Hydrocodone Bitartrate
- Product NDC
- 47781-412
- 11-digit product format
- 477810412
- Labeler code
- 47781
- Product ID
- 47781-412_efb4a6cd-a407-a935-70b9-6ab1074ca819
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Alvogen Inc.
- Application
- ANDA206986
- Marketing category
- ANDA
- Marketing start
- 2020-01-21
- Substance
- HYDROCODONE BITARTRATE
- Active strength
- 30 mg/1
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydrocodone Bitartrate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCODONE BITARTRATE | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | NO70W886KK |
| Rxcui | 1860491, 1860493, 1860495, 1860497, 1860499, 1860501 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 47781-412-60 | Hydrocodone Bitartrate | 60 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 60 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47781-412 | HYDROCODONE BITARTRATE CAPSULE, EXTENDED RELEASE [ALVOGEN INC.] | 6 | Current NDC, Legacy NDC, 1 package rows | 20241121_a7b8ea07-e926-f0a5-c20d-92f23ed350d0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 47781-412-60 | 47781041260 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47781-412-60) | 2020-01-21 | 0000-00-00 | No | No | Current |