Hydrocodone Bitartrate and Homatropine Methylbromide
- Product NDC
- 10702-055
- 11-digit product format
- 107020055
- Labeler code
- 10702
- Product ID
- 10702-055_47ba86ad-2410-e733-e063-6394a90a24e3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Homatropine Methylbromide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- KVK-Tech, Inc.
- Application
- ANDA207176
- Marketing category
- ANDA
- Marketing start
- 2017-08-07
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydrocodone Bitartrate and Homatropine Methylbromide
- Listing expiration
- 2027-12-31
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 |
|---|
| 10702-055-01 | Hydrocodone Bitartrate and Homatropine Methylbromide | 100 in 1 BOTTLE | TABLET | 100 | | 9 |
| 10702-055-03 | Hydrocodone Bitartrate and Homatropine Methylbromide | 30 in 1 BOTTLE | TABLET | 30 | | 9 |
| 10702-055-09 | Hydrocodone Bitartrate and Homatropine Methylbromide | 90 in 1 BOTTLE | TABLET | 90 | | 9 |
| 10702-055-10 | Hydrocodone Bitartrate and Homatropine Methylbromide | 1000 in 1 BOTTLE | TABLET | 1000 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10702-055 | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLET [KVK-TECH, INC.] | 8 | Current NDC, Legacy NDC, 4 package rows | 20181220_26d7c90c-5e6b-4bdb-b06f-c76173a01c21.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 |
|---|
| 10702-055-01 | 10702005501 | 100 TABLET in 1 BOTTLE (10702-055-01) | 100 tablet | 2017-08-07 | 0000-00-00 | No | No | Current |
| 10702-055-03 | 10702005503 | 30 TABLET in 1 BOTTLE (10702-055-03) | 30 tablet | 2017-08-07 | 0000-00-00 | No | No | Current |
| 10702-055-09 | 10702005509 | 90 TABLET in 1 BOTTLE (10702-055-09) | 90 tablet | 2017-08-07 | 0000-00-00 | No | No | Current |
| 10702-055-10 | 10702005510 | 1000 TABLET in 1 BOTTLE (10702-055-10) | 1000 tablet | 2017-08-07 | 0000-00-00 | No | No | Current |