Cyclobenzaprine hydrochloride
- Product NDC
- 53002-0523
- 11-digit product format
- 530020523
- Labeler code
- 53002
- Product ID
- 53002-0523_efd2ef8a-b380-4499-91ed-77f97000a473
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA213324
- Marketing category
- ANDA
- Marketing start
- 2020-07-06
- Marketing end
- 0000-00-00
- Substance
- CYCLOBENZAPRINE HYDROCHLORIDE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-0523-1 | Cyclobenzaprine hydrochloride | 5 in 1 BOTTLE | TABLET, FILM COATED | 5 | | 1 |
| 53002-0523-2 | Cyclobenzaprine hydrochloride | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 1 |
| 53002-0523-3 | Cyclobenzaprine hydrochloride | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 1 |
| 53002-0523-4 | Cyclobenzaprine hydrochloride | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 1 |
| 53002-0523-5 | Cyclobenzaprine hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-0523 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.] | 1 | Legacy NDC, 5 package rows | 20220331_eb94a3f6-24dd-4847-8c05-22c49b853655.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53002-0523-1 | 53002052301 | 5 TABLET, FILM COATED in 1 BOTTLE (53002-0523-1) | 2022-09-01 | 0000-00-00 | No | No | Current |
| 53002-0523-2 | 53002052302 | 10 TABLET, FILM COATED in 1 BOTTLE (53002-0523-2) | 2022-09-01 | 0000-00-00 | No | No | Current |
| 53002-0523-3 | 53002052303 | 15 TABLET, FILM COATED in 1 BOTTLE (53002-0523-3) | 2022-09-01 | 0000-00-00 | No | No | Current |
| 53002-0523-4 | 53002052304 | 20 TABLET, FILM COATED in 1 BOTTLE (53002-0523-4) | 2022-09-01 | 0000-00-00 | No | No | Current |
| 53002-0523-5 | 53002052305 | 30 TABLET, FILM COATED in 1 BOTTLE (53002-0523-5) | 2022-09-01 | 0000-00-00 | No | No | Current |