Hydrocodone Bitartrate and Homatropine Methylbromide
- Product NDC
- 43386-118
- 11-digit product format
- 433860118
- Labeler code
- 43386
- Product ID
- 43386-118_116df522-26b7-42de-8c0b-16cc60c2e764
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Homatropine Methylbromide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals,Inc.
- Application
- ANDA091528
- Marketing category
- ANDA
- Marketing start
- 2014-09-23
- Substance
- HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE
- Active strength
- 1.5; 5 mg/1; 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 and Homatropine Methylbromide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HOMATROPINE METHYLBROMIDE | 1.5 mg/1 |
| HYDROCODONE BITARTRATE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 68JRS2HC1C, NO70W886KK |
| Rxcui | 992656 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43386-118-01 | Hydrocodone Bitartrate and Homatropine Methylbromide | 100 in 1 BOTTLE | TABLET | 100 | | 6 |
| 43386-118-03 | Hydrocodone Bitartrate and Homatropine Methylbromide | 30 in 1 BOTTLE | TABLET | 30 | | 6 |
| 43386-118-05 | Hydrocodone Bitartrate and Homatropine Methylbromide | 500 in 1 BOTTLE | TABLET | 500 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| HOMATROPINE METHYLBROMIDE | ACTIVE INGREDIENT | 68JRS2HC1C | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLET [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| HYDROCODONE BITARTRATE | ACTIVE INGREDIENT | NO70W886KK | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLET [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| HYDROCODONE | ACTIVE MOIETY | 6YKS4Y3WQ7 | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLET [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| METHYLHOMATROPINE | ACTIVE MOIETY | P97OGJ7L1L | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLET [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | INACTIVE INGREDIENT | L11K75P92J | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLET [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLET [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLET [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLET [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLET [GAVIS PHARMACEUTICALS, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43386-118 | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLET [LUPIN PHARMACEUTICALS,INC.] | 6 | Current NDC, Legacy NDC, 3 package rows | 20241204_41ac90b3-f007-4eb2-9d41-ea626ced2017.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 |
|---|
| 43386-118-01 | 43386011801 | 100 TABLET in 1 BOTTLE (43386-118-01) | 100 tablet | 2014-09-23 | 0000-00-00 | Yes | No | Current |
| 43386-118-03 | 43386011803 | 30 TABLET in 1 BOTTLE (43386-118-03) | 30 tablet | 2014-09-23 | 0000-00-00 | Yes | No | Current |
| 43386-118-05 | 43386011805 | 500 TABLET in 1 BOTTLE (43386-118-05) | 500 tablet | 2014-09-23 | 0000-00-00 | No | No | Current |