Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 53217-192
- 11-digit product format
- 532170192
- Labeler code
- 53217
- Product ID
- 53217-192_bdefe013-f1c1-4262-9773-cfab52bb5c1f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA040148
- Marketing category
- ANDA
- Marketing start
- 2014-10-06
- Marketing end
- 0000-00-00
- Substance
- HYDROCODONE BITARTRATE; ACETAMINOPHEN
- Active strength
- 3 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC],Opioid Agonists [MoA]
- DEA schedule
- CII
- 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 |
|---|
| 53217-192-02 | Hydrocodone Bitartrate and Acetaminophen | 02 in 1 BOTTLE | TABLET | 02 | | 1 |
| 53217-192-30 | Hydrocodone Bitartrate and Acetaminophen | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 53217-192-60 | Hydrocodone Bitartrate and Acetaminophen | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
| 53217-192-90 | Hydrocodone Bitartrate and Acetaminophen | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53217-192 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | Legacy NDC, 4 package rows | 20170302_8f7a1e1c-88b1-4353-a2f1-56880eae7eeb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53217-192-02 | 53217019202 | 02 in 1 BOTTLE | Historical |
| 53217-192-30 | 53217019230 | 30 in 1 BOTTLE | Historical |
| 53217-192-60 | 53217019260 | 60 in 1 BOTTLE | Historical |
| 53217-192-90 | 53217019290 | 90 in 1 BOTTLE | Historical |