HYDROCODONE BITARTRATE AND ACETAMINOPHEN
- Product NDC
- 21695-386
- 11-digit product format
- 216950386
- Labeler code
- 21695
- Product ID
- 21695-386_5dad6fbc-2e4d-49dc-8810-721a7701f01e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDROCODONE BITARTRATE AND ACETAMINOPHEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA090118
- Marketing category
- ANDA
- Marketing start
- 2009-03-30
- Marketing end
- 0000-00-00
- Substance
- HYDROCODONE BITARTRATE; ACETAMINOPHEN
- Active strength
- 8 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC],Opioid Agonists [MoA]
- DEA schedule
- CIII
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 |
|---|
| 21695-386-10 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 10 in 1 BOTTLE | TABLET | 10 | | 1 |
| 21695-386-30 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 21695-386-60 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21695-386 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP] | 1 | Legacy NDC, 3 package rows | 20110407_5dad6fbc-2e4d-49dc-8810-721a7701f01e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 21695-386-10 | 21695038610 | 10 in 1 BOTTLE | Historical |
| 21695-386-30 | 21695038630 | 30 in 1 BOTTLE | Historical |
| 21695-386-60 | 21695038660 | 60 in 1 BOTTLE | Historical |