Carisoprodol
- Product NDC
- 53489-110
- 11-digit product format
- 534890110
- Labeler code
- 53489
- Product ID
- 53489-110_cdfbe64d-ba89-4cb7-bc1a-3bfaadd0258c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carisoprodol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mutual Pharmaceutical Company, Inc.
- Application
- ANDA089346
- Marketing category
- ANDA
- Marketing start
- 1991-10-17
- Marketing end
- 0000-00-00
- Substance
- CARISOPRODOL
- Active strength
- 350 mg/1
- Pharmacologic classes
- Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
- DEA schedule
- CIV
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 53489-110-01 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-4a7c-60a7-e053-dbdaa90a05bd | These highlights do not include all the information needed to use CARISOPRODOL tablets USP safely and effectively. See full prescribing information for carisoprodol. CARISOPRODOL tablets, USP for oral use, C-IV Initial U.S. Approval: 1959 |
| 53489-110-05 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-4a7c-60a7-e053-dbdaa90a05bd | These highlights do not include all the information needed to use CARISOPRODOL tablets USP safely and effectively. See full prescribing information for carisoprodol. CARISOPRODOL tablets, USP for oral use, C-IV Initial U.S. Approval: 1959 |
| 53489-110-06 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-4a7c-60a7-e053-dbdaa90a05bd | These highlights do not include all the information needed to use CARISOPRODOL tablets USP safely and effectively. See full prescribing information for carisoprodol. CARISOPRODOL tablets, USP for oral use, C-IV Initial U.S. Approval: 1959 |
| 53489-110-07 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-4a7c-60a7-e053-dbdaa90a05bd | These highlights do not include all the information needed to use CARISOPRODOL tablets USP safely and effectively. See full prescribing information for carisoprodol. CARISOPRODOL tablets, USP for oral use, C-IV Initial U.S. Approval: 1959 |
| 53489-110-10 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-4a7c-60a7-e053-dbdaa90a05bd | These highlights do not include all the information needed to use CARISOPRODOL tablets USP safely and effectively. See full prescribing information for carisoprodol. CARISOPRODOL tablets, USP for oral use, C-IV Initial U.S. Approval: 1959 |
| 53489-110-60 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-4a7c-60a7-e053-dbdaa90a05bd | These highlights do not include all the information needed to use CARISOPRODOL tablets USP safely and effectively. See full prescribing information for carisoprodol. CARISOPRODOL tablets, USP for oral use, C-IV Initial U.S. Approval: 1959 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53489-110-01 | Carisoprodol | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 8 |
| 53489-110-05 | Carisoprodol | 500 in 1 BOTTLE, PLASTIC | TABLET | 500 | | 8 |
| 53489-110-06 | Carisoprodol | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 8 |
| 53489-110-07 | Carisoprodol | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 8 |
| 53489-110-10 | Carisoprodol | 1000 in 1 BOTTLE, PLASTIC | TABLET | 1000 | | 8 |
| 53489-110-60 | Carisoprodol | 20 in 1 BOTTLE, PLASTIC | TABLET | 20 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Carisoprodol | ACTIVE INGREDIENT | 21925K482H | CARISOPRODOL TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 8 | |
| Carisoprodol | ACTIVE MOIETY | 21925K482H | CARISOPRODOL TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 8 | |
| lactose | INACTIVE INGREDIENT | J2B2A4N98G | CARISOPRODOL TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 8 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | CARISOPRODOL TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 8 | |
| povidones | INACTIVE INGREDIENT | FZ989GH94E | CARISOPRODOL TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 8 | |
| sodium lauryl sulfate | INACTIVE INGREDIENT | 368GB5141J | CARISOPRODOL TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 8 | |
| sodium starch glycolate type a potato | INACTIVE INGREDIENT | 5856J3G2A2 | CARISOPRODOL TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 8 | |
| starch, corn | INACTIVE INGREDIENT | O8232NY3SJ | CARISOPRODOL TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 8 | |
| stearic acid | INACTIVE INGREDIENT | 4ELV7Z65AP | CARISOPRODOL TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 8 | |
| CARISOPRODOL | ACTIVE INGREDIENT | 21925K482H | CARISOPRODOL TABLET [APOTHECA, INC.] | 4 | |
| CARISOPRODOL | ACTIVE MOIETY | 21925K482H | CARISOPRODOL TABLET [APOTHECA, INC.] | 4 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | CARISOPRODOL TABLET [APOTHECA, INC.] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CARISOPRODOL TABLET [APOTHECA, INC.] | 4 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | CARISOPRODOL TABLET [APOTHECA, INC.] | 4 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | CARISOPRODOL TABLET [APOTHECA, INC.] | 4 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | CARISOPRODOL TABLET [APOTHECA, INC.] | 4 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | CARISOPRODOL TABLET [APOTHECA, INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53489-110 | CARISOPRODOL TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 8 | Legacy NDC, 6 package rows | 20140303_76a36c15-38d3-442e-84a0-b0649a213d13.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53489-110-01 | 53489011001 | 100 in 1 BOTTLE, PLASTIC | Historical |
| 53489-110-05 | 53489011005 | 500 in 1 BOTTLE, PLASTIC | Historical |
| 53489-110-06 | 53489011006 | 60 in 1 BOTTLE, PLASTIC | Historical |
| 53489-110-07 | 53489011007 | 30 in 1 BOTTLE, PLASTIC | Historical |
| 53489-110-10 | 53489011010 | 1000 in 1 BOTTLE, PLASTIC | Historical |
| 53489-110-60 | 53489011060 | 20 in 1 BOTTLE, PLASTIC | Historical |