NDC 59385-021 – Belbuca
Buprenorphine Hydrochloride 75 ug/1 · Film, Soluble · Buccal
Product NDC59385-021
Product details
- Brand name
- Belbuca
- Generic name
- Buprenorphine hydrochloride
- Labeler
- BioDelivery Sciences International Inc
- Dosage form
- Film, Soluble
- Route
- Buccal
- Marketing category
- NDA · NDA207932
- Marketed since
- September 1, 2017
- Listing expires
- December 31, 2027
- Pharmacologic class
- Partial Opioid Agonist
Active ingredients
- Buprenorphine Hydrochloride 75 ug/1
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 59385-021-60 | 60 POUCH in 1 CARTON (59385-021-60) / 1 FILM, SOLUBLE in 1 POUCH (59385-021-01) | Sep 1, 2017 |
Recalls mentioning this NDC
- D-0448-2021 Jun 2, 2021 · Class II
CGMP Deviations: Intermittent exposure to temperature excursion during storage. - D-0449-2021 Jun 2, 2021 · Class II
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Other Belbuca products
- 59385-022 Buprenorphine Hydrochloride 150 ug/1 · Film, Soluble · BioDelivery Sciences International Inc
- 59385-023 Buprenorphine Hydrochloride 300 ug/1 · Film, Soluble · BioDelivery Sciences International Inc
- 59385-024 Buprenorphine Hydrochloride 450 ug/1 · Film, Soluble · BioDelivery Sciences International Inc
- 59385-025 Buprenorphine Hydrochloride 600 ug/1 · Film, Soluble · BioDelivery Sciences International Inc
- 59385-026 Buprenorphine Hydrochloride 750 ug/1 · Film, Soluble · BioDelivery Sciences International Inc
- 59385-027 Buprenorphine Hydrochloride 900 ug/1 · Film, Soluble · BioDelivery Sciences International Inc