Product Information
BUPRENORPHINE-NALOXONE 12-3 MG SL FILM is a generic product labeled by Mylan Pharmaceuticals Inc., priced at $4.4680 per EA under NDC 00378876893. Its NADAC has been published 379 times since May 22, 2019.
FDA first approved this application on Jun 14, 2018. Its Orange Book therapeutic-equivalence code is AB — FDA rates it therapeutically equivalent to (substitutable for) its reference product.
Strength
12; 3 mg/1; mg/1
Manufacturer
Mylan Pharmaceuticals Inc.NDC
00378876893
Classification
Generic
Dosage Form
FILM
Route
BUCCAL; SUBLINGUAL
Effective Date
8/19/2026
Active Ingredients
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATEApproval Type
Generic (ANDA)
FDA Application
ANDA207607FDA Approved
6/14/2018
TE Code
AB
On Market Since
2/20/2019
Pharmacological Classes
Price Statistics
The NADAC for BUPRENORPHINE-NALOXONE 12-3 MG SL FILM has been published 379 times since May 22, 2019, and over the history we have for it it has declined 62.2%. The table below summarizes its recorded NADAC range and movement.
| Current price | $4.4680 per EA |
|---|---|
| All-time high | $11.8317 (Jun 12, 2019) |
| All-time low | $3.8234 (Apr 17, 2024) |
| 52-week high | $4.4680 |
| 52-week low | $4.1480 |
| Median price | $6.9327 |
| Average price | $6.8797 |
| Largest weekly change | +62.0% (Aug 21, 2024) |
| Weeks tracked | 379 |
| Tracking since | May 22, 2019 |
Generic Alternatives
The matcher finds 2 manufacturers offering a NADAC-published product with this drug's active ingredient and strength in a comparable dosage form (cheapest from each manufacturer, up to 10 shown below). None of the shown alternatives sit below the current price. These are candidates to verify clinically, not guaranteed substitutes — see our generic drug prices guide.
Related Drugs
Same classification
Frequently asked questions
What is the NADAC price of BUPRENORPHINE-NALOXONE 12-3 MG SL FILM?
The current National Average Drug Acquisition Cost (NADAC) for BUPRENORPHINE-NALOXONE 12-3 MG SL FILM, manufactured by Mylan Pharmaceuticals Inc., is $4.4680 per EA (NDC 00378876893), effective Aug 19, 2026.
How has the price of BUPRENORPHINE-NALOXONE 12-3 MG SL FILM changed over time?
Over the history we have for it, the NADAC for BUPRENORPHINE-NALOXONE 12-3 MG SL FILM has declined 62.2%. It has been tracked across 379 weekly CMS publications since May 22, 2019.
What are the highest and lowest recorded NADAC prices for BUPRENORPHINE-NALOXONE 12-3 MG SL FILM?
Since May 22, 2019, the NADAC for BUPRENORPHINE-NALOXONE 12-3 MG SL FILM has ranged from a low of $3.8234 (Apr 17, 2024) to a high of $11.8317 (Jun 12, 2019), with a median of $6.9327 per EA.
Are there cheaper alternatives to BUPRENORPHINE-NALOXONE 12-3 MG SL FILM?
2 manufacturers publish a NADAC-priced product with the same active ingredient and strength as BUPRENORPHINE-NALOXONE 12-3 MG SL FILM in a comparable dosage form, but none are currently priced below it.
Who manufactures BUPRENORPHINE-NALOXONE 12-3 MG SL FILM?
BUPRENORPHINE-NALOXONE 12-3 MG SL FILM (NDC 00378876893) is labeled by Mylan Pharmaceuticals Inc., and CMS classifies it as a generic product.