CARISOPRODOL
- Product NDC
- 68071-5075
- 11-digit product format
- 680715075
- Labeler code
- 68071
- Product ID
- 68071-5075_1b46743c-f411-528b-e063-6394a90a3505
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CARISOPRODOL
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA203374
- Marketing category
- ANDA
- Marketing start
- 2014-01-27
- Substance
- CARISOPRODOL
- Active strength
- 350 mg/1
- Pharmacologic classes
- Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- CARISOPRODOL
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CARISOPRODOL | 350 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 21925K482H |
| Rxcui | 197446 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 68071-5075-3 | 2024-06-19 | C162847 | 48780-1 | ba0f9c33-476a-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use CARISOPRODOL tablets, USP safely and effectively. See full prescribing information for CARISOPRODOL tablets, USP. Carisoprodol tablets, USP for Oral use CIV Initial U.S. Approval: 1959 |
| 68071-5075-3 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-476a-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use CARISOPRODOL tablets, USP safely and effectively. See full prescribing information for CARISOPRODOL tablets, USP. Carisoprodol tablets, USP for Oral use CIV Initial U.S. Approval: 1959 |
| 68071-5075-3 | 2021-02-19 | C162847 | 48780-1 | ba0f9c33-476a-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use CARISOPRODOL tablets, USP safely and effectively. See full prescribing information for CARISOPRODOL tablets, USP. Carisoprodol tablets, USP for Oral use CIV Initial U.S. Approval: 1959 |
| 68071-5075-3 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-476a-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use CARISOPRODOL tablets, USP safely and effectively. See full prescribing information for CARISOPRODOL tablets, USP. Carisoprodol tablets, USP for Oral use CIV Initial U.S. Approval: 1959 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-5075-3 | CARISOPRODOL | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-5075 | CARISOPRODOL TABLET [NUCARE PHARMACEUTICALS,INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240621_93cbe188-5443-b392-e053-2995a90a9ac7.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 |
|---|
| 68071-5075-3 | 68071507503 | 30 TABLET in 1 BOTTLE (68071-5075-3) | 30 tablet | 2019-09-30 | 0000-00-00 | No | No | Current |