Suboxone
- Product NDC
- 53217-328
- 11-digit product format
- 532170328
- Labeler code
- 53217
- Product ID
- 53217-328_4f1210ae-a8ec-4253-b825-35e66ac93a1c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- buprenorphine hydrochloride, naloxone hydrochloride
- Dosage form
- FILM, SOLUBLE
- Route
- SUBLINGUAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- NDA022410
- Marketing category
- NDA
- Marketing start
- 2010-09-13
- Marketing end
- 0000-00-00
- Substance
- BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
- Active strength
- 8 mg/1; mg/1
- Pharmacologic classes
- Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53217-328-01 | Suboxone | 30 in 1 CARTON | FILM, SOLUBLE | 30 | | 4 |
| 53217-328-01 | Suboxone | 1 in 1 POUCH | FILM, SOLUBLE | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53217-328 | SUBOXONE (BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE) FILM, SOLUBLE [AIDAREX PHARMACEUTICALS LLC] | 4 | Legacy NDC, 2 package rows | 20180601_54c487ac-750b-462e-a4cb-dcab1dd43ba8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53217-328-01 | 53217032801 | 30 in 1 CARTON | Historical |