Hydrocodone Bitartrate and Homatropine Methylbromide
- Product NDC
- 60432-455
- 11-digit product format
- 604320455
- Labeler code
- 60432
- Product ID
- 60432-455_58db75ad-7605-4459-b6b8-c91619767eea
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydrocodone bitartrate and homatropine methylbromide
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Morton Grove Pharmaceuticals, Inc.
- Application
- ANDA088008
- Marketing category
- ANDA
- Marketing start
- 1983-03-03
- Marketing end
- 0000-00-00
- Substance
- HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE
- Active strength
- 2 mg/5mL; mg/5mL
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
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 SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] | 3 | |
| Hydrocodone Bitartrate | ACTIVE INGREDIENT | NO70W886KK | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] | 3 | |
| HYDROCODONE | ACTIVE MOIETY | 6YKS4Y3WQ7 | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] | 3 | |
| METHYLHOMATROPINE | ACTIVE MOIETY | P97OGJ7L1L | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] | 3 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] | 3 | |
| CARAMEL | INACTIVE INGREDIENT | T9D99G2B1R | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] | 3 | |
| D&C RED NO. 33 | INACTIVE INGREDIENT | 9DBA0SBB0L | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] | 3 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] | 3 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] | 3 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] | 3 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] | 3 | |
| Sorbitol | INACTIVE INGREDIENT | 506T60A25R | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] | 3 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] | 3 | |
| TRISODIUM CITRATE DIHYDRATE | INACTIVE INGREDIENT | B22547B95K | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] | 3 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60432-455 | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] | 8 | Legacy NDC | 20220210_58ddde62-2ba2-4f39-8e32-5130d3963144.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 |
|---|
| 60432-455-16 | 60432045516 | 473 mL in 1 BOTTLE, PLASTIC (60432-455-16) | 473 ml | 1983-03-03 | 0000-00-00 | No | No | Current |
| 60432-455-28 | 60432045528 | 3785 mL in 1 BOTTLE, PLASTIC (60432-455-28) | 3785 ml | 1983-03-03 | 0000-00-00 | No | No | Current |