BUPRENORPHINE HCL
- Product NDC
- 76519-1170
- 11-digit product format
- 765191170
- Labeler code
- 76519
- Product ID
- 76519-1170_77d3c308-58b9-2ab0-e053-2991aa0a4918
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BUPRENORPHINE HCL
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- H.J. Harkins Company, Inc.
- Application
- ANDA078633
- Marketing category
- ANDA
- Marketing start
- 2018-03-16
- Marketing end
- 0000-00-00
- Substance
- BUPRENORPHINE HYDROCHLORIDE
- Active strength
- 8 mg/1
- Pharmacologic classes
- Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
- 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 |
|---|
| 76519-1170-0 | BUPRENORPHINE HCLSL | 14 in 1 BOTTLE | TABLET | 14 | | 1 |
| 76519-1170-1 | BUPRENORPHINE HCLSL | 28 in 1 BOTTLE | TABLET | 28 | | 1 |
| 76519-1170-2 | BUPRENORPHINE HCLSL | 56 in 1 BOTTLE | TABLET | 56 | | 1 |
| 76519-1170-3 | BUPRENORPHINE HCLSL | 70 in 1 BOTTLE | TABLET | 70 | | 1 |
| 76519-1170-4 | BUPRENORPHINE HCLSL | 84 in 1 BOTTLE | TABLET | 84 | | 1 |
| 76519-1170-5 | BUPRENORPHINE HCLSL | 42 in 1 BOTTLE | TABLET | 42 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76519-1170 | BUPRENORPHINE HCL SL (BUPRENORPHINE HCL) TABLET [H.J. HARKINS COMPANY, INC.] | 1 | Legacy NDC, 6 package rows | 20181024_77d3c308-58b8-2ab0-e053-2991aa0a4918.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 76519-1170-0 | 76519117000 | 14 in 1 BOTTLE | Historical |
| 76519-1170-1 | 76519117001 | 28 in 1 BOTTLE | Historical |
| 76519-1170-2 | 76519117002 | 56 in 1 BOTTLE | Historical |
| 76519-1170-3 | 76519117003 | 70 in 1 BOTTLE | Historical |
| 76519-1170-4 | 76519117004 | 84 in 1 BOTTLE | Historical |
| 76519-1170-5 | 76519117005 | 42 in 1 BOTTLE | Historical |