Hydrocodone Bitartrate and Homatropine Methylbromide
- Product NDC
- 10702-150
- 11-digit product format
- 107020150
- Labeler code
- 10702
- Product ID
- 10702-150_526d7f1f-bdeb-5e1f-e063-6294a90a6916
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydrocodone bitartrate and homatropine methylbromide oral solution
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- KVK-Tech, Inc.
- Application
- ANDA207487
- Marketing category
- ANDA
- Marketing start
- 2017-02-21
- 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
- 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/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 |
|---|
| 10702-150-16 | Hydrocodone Bitartrate and Homatropine Methylbromide | 473 mL in 1 BOTTLE | LIQUID | 473 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10702-150 | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE ORAL SOLUTION) LIQUID [KVK-TECH, INC.] | 11 | Current NDC, Legacy NDC, 1 package rows | 20181220_9a737416-08e0-4df6-897e-cf9d1b5f0b01.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 |
|---|
| 10702-150-16 | 10702015016 | 473 mL in 1 BOTTLE (10702-150-16) | 473 ml | 2017-02-21 | 0000-00-00 | No | No | Current |