NDC 47781-358 – Buprenorphine and Naloxone Sublingual Film
Buprenorphine Hydrochloride 12 mg/1; Naloxone Hydrochloride Dihydrate 3 mg/1 · Film · Buccal, Sublingual
Product NDC47781-358
Product details
- Brand name
- Buprenorphine and Naloxone Sublingual Film
- Generic name
- Buprenorphine and Naloxone
- Labeler
- Alvogen Inc.
- Dosage form
- Film
- Route
- Buccal, Sublingual
- Marketing category
- ANDA · ANDA205954
- Marketed since
- February 11, 2019
- Listing expires
- December 31, 2027
- Pharmacologic class
- Opioid Antagonist; Partial Opioid Agonist
Active ingredients
- Buprenorphine Hydrochloride 12 mg/1
- Naloxone Hydrochloride Dihydrate 3 mg/1
Uses, dosage, side effects and warnings for Buprenorphine and Naloxone →
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 47781-358-03 | 30 POUCH in 1 CARTON (47781-358-03) / 1 FILM in 1 POUCH (47781-358-11) | Feb 11, 2019 |
Recalls mentioning this NDC
- D-0649-2021 Jul 14, 2021 · Class II
Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
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