Hydrocodone Bitartrate and Homatropine Methylbromide
- Product NDC
- 0121-1036
- 11-digit product format
- 001211036
- Labeler code
- 0121
- Product ID
- 0121-1036_3b3068f2-238d-46b3-b80d-a0ae90142908
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Homatropine Methylbromide
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- PAI Holdings, LLC dba PAI Pharma
- Application
- NDA005213
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2024-08-05
- 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 |
|---|
| 0121-1036-05 | Hydrocodone Bitartrate and Homatropine Methylbromide | 5 mL in 1 CUP, UNIT-DOSE | SOLUTION | 5 | | 1 |
| 0121-1036-40 | Hydrocodone Bitartrate and Homatropine Methylbromide | 4 in 1 CASE | SOLUTION | 4 | | 1 |
| 0121-1036-40 | Hydrocodone Bitartrate and Homatropine Methylbromide | 10 in 1 TRAY | SOLUTION | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0121-1036 | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] | 1 | Current NDC, 3 package rows | 20240806_71319a6f-aaf4-4bc5-8b40-a16c6f139be6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0121-1036-05 | 00121103605 | 5 mL in 1 CUP, UNIT-DOSE | 5 ml | | | | Historical |
| 0121-1036-40 | 00121103640 | 4 TRAY in 1 CASE (0121-1036-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-1036-05) | 4 tray | 2024-08-05 | No | No | Historical |