Hydrocodone Bitartrate and Homatropine Methylbromide
- Product NDC
- 40032-810
- 11-digit product format
- 400320810
- Labeler code
- 40032
- Product ID
- 40032-810_c524711b-29fd-41d1-b026-072e7314b06a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Homatropine Methylbromide
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Novel Laboratories, Inc.
- Application
- ANDA203535
- Marketing category
- ANDA
- Marketing start
- 2017-02-13
- Substance
- HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE
- Active strength
- 1.5; 5 mg/5mL; mg/5mL
- 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 and Homatropine Methylbromide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HOMATROPINE METHYLBROMIDE | 1.5 mg/5mL |
| HYDROCODONE BITARTRATE | 5 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 68JRS2HC1C, NO70W886KK |
| Rxcui | 992668 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 40032-810-05 | Hydrocodone Bitartrate and Homatropine Methylbromide | 473 mL in 1 BOTTLE | SYRUP | 473 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 40032-810 | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [NOVEL LABORATORIES, INC.] | 8 | Current NDC, Legacy NDC, 1 package rows | 20241204_4050ae05-7f1a-48b7-99b9-f8db8aa02741.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 40032-810-05 | 40032081005 | 473 mL in 1 BOTTLE (40032-810-05) | 473 ml | 2017-02-13 | 0000-00-00 | Yes | No | Current |