Manufacturers/American Regent, Inc.

American Regent, Inc.

20 drugs in NADAC|17 Generic,3 Brand

View Recalls (8)

American Regent, Inc. lists 20 NDCs in the CMS NADAC file (17 generic, 3 brand), at an average NADAC of $8.49 per unit, with a week-over-week move of +0.8% across products that moved. The firm's full portfolio, pricing trend, and FDA recalls are listed below.

Total Drugs

20

17G / 3B

Avg Price / Unit

$8.4872

$0.07 – $34.18

Avg 7d Change

+0.80%

Across 13 drugs with changes

7d Activity

677 flat

of 20 total drugs

Portfolio Price Trend

Monthly average NADAC price across all drugs

Frequently Asked Questions

How many drugs does American Regent, Inc. make?

American Regent, Inc. lists 20 NDCs in the CMS NADAC file — 17 generic and 3 brand products.

What is the average price of American Regent, Inc. drugs?

The average NADAC across American Regent, Inc.'s portfolio is $8.4872 per unit, ranging from $0.0661 to $34.1832.

What types of drugs does American Regent, Inc. make?

American Regent, Inc. makes drugs across 13 FDA pharmacologic classes. The most common by NDC count are Corticosteroid (6), Parenteral Iron Replacement (3), Phosphate Binder (3), Antidote (3), Antidote for Acetaminophen Overdose (3).

Has American Regent, Inc. had any drug recalls?

8 FDA recalls are matched to American Regent, Inc. in the openFDA feed, most recently on Apr 16, 2026.

How has American Regent, Inc.'s pricing changed recently?

Over the past 7 days, 6 American Regent, Inc. products rose and 7 fell, with a portfolio-wide average change of +0.8%.

Drug Portfolio

20 drugs total, 20 shown

Drug Price 7d Change
ESTRADIOL VALERATE 200 MG/5 ML
ESTRADIOL VALERATE
$34.1832
per ML
+1.63%
OLANZAPINE 10 MG VIAL
Olanzapine
$22.1658
per EA
+1.32%
ESTRADIOL VALERATE 100 MG/5 ML
ESTRADIOL VALERATE
$20.9000
per ML
-0.49%
VENOFER 200 MG/10 ML VIAL
iron sucrose
$12.5305
per ML
TESTOSTERONE CYP 200 MG/ML
Testosterone Cypionate
$12.3075
per ML
VENOFER 100 MG/5 ML VIAL
iron sucrose
$12.2067
per ML
VENOFER 100 MG/5 ML VIAL
iron sucrose
$12.2067
per ML
BETAMETHASONE SP-AC 30 MG/5 ML
Betamethasone Sodium Phosphate and Betamethasone Acetate
$9.4576
per ML
-0.05%
BETAMETHASONE SP-AC 30 MG/5 ML
Betamethasone Sodium Phosphate and Betamethasone Acetate
$9.4576
per ML
-0.05%
BETAMETHASONE SP-AC 30 MG/5 ML
Betamethasone Sodium Phosphate and Betamethasone Acetate
$9.4576
per ML
-0.05%
HYDROXYZINE 25 MG/ML VIAL
Hydroxyzine Hydrochloride
$2.8346
per ML
ACETYLCYSTEINE 10% VIAL (NOT FOR INJECTION)
acetylcysteine
$2.6373
per ML
+3.14%
ACETYLCYSTEINE 20% VIAL (NOT FOR INJECTION)
acetylcysteine
$2.2755
per ML
-4.11%
CYANOCOBALAMIN 10,000 MCG/10 ML
cyanocobalamin
$1.9731
per ML
+0.78%
CYANOCOBALAMIN 1,000 MCG/ML VL
cyanocobalamin
$1.4915
per ML
-0.88%
GLYCOPYRROLATE 0.2 MG/ML VIAL
Glycopyrrolate
$1.3269
per ML
+3.22%
ACETYLCYSTEINE 20% VIAL
acetylcysteine
$1.1883
per ML
CYANOCOBALAMIN 30,000 MCG/30 ML
cyanocobalamin
$0.7612
per ML
+6.79%
WATER FOR INJECTION VIAL
Water
$0.3160
per ML
-0.89%
WATER FOR INJECTION VIAL
Water
$0.0661
per ML

FDA Recalls (8)

Recalls matched by company name. Verify current status with FDA.

D-0494-2026
Ongoing
Class III

Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC: 0517-1045-01

Labeling: Missing Label

Initiated: 4/16/2026
D-0398-2025
Ongoing
Class II

niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, Mfd for: Civica, Inc., Lehi, UT 84043,Mfd by: American Regent, Inc., New Albany, OH 43064. NDC Carton: 72572-470-10/ NDC Vial: 72572-470-01.

Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.

Initiated: 4/18/2025
D-0399-2025
Ongoing
Class II

niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC carton: 0517-0735-10 / NDC Vial: 0517-0735-01]

Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.

Initiated: 4/18/2025
D-0080-2025
Ongoing
Class II

Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-534-01 (vial), NDC: 49230-534-25 (25 x 5 mL/vial cartons).

Presence of Particulate Matter: Potential for glass delamination from the vials.

Initiated: 11/11/2024
D-0082-2025
Ongoing
Class II

Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, American Regent, Inc. Shirley, NY 11967, NDC: 0517-2340-01 (vial), NDC: 0517-2340-10 (10 x 5 mL/vial cartons), NDC: 0517-2340-25 (25 x 5 mL/vial cartons).

Presence of Particulate Matter: Potential for glass delamination from the vials.

Initiated: 11/11/2024
D-0081-2025
Ongoing
Class II

Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-530-01 (vial), NDC: 49230-530-10 (10 x 2.5mL/vial cartons), NDC: 49230-530-25 (25 x 2.5mL/vial cartons).

Presence of Particulate Matter: Potential for glass delamination from the vials.

Initiated: 11/11/2024
D-0503-2024
Terminated
Class II

niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For Intravenous Use Only, Mfd for: Civica, Inc., Lehi, UT 84043; Mfd by: American Regent, Inc., New Albany, OH 43054. NDC 72572-470-10

Lack of Assurance of Sterility.

Initiated: 5/14/2024
D-0507-2024
Terminated
Class II

Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose Vial, Rx only, For Intravenous Infusion, American Regent, Inc., Shirley, NY 11967, NDC 0517-1030-01

Subpotent product in addition to having out-of-specification results for impurities.

Initiated: 5/13/2024