Cyclobenzaprine Hydrochloride
- Product NDC
- 53002-3080
- 11-digit product format
- 530023080
- Labeler code
- 53002
- Product ID
- 53002-3080_c8f550ff-b040-40d3-ad88-c88a1cb67b04
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA090478
- Marketing category
- ANDA
- Marketing start
- 2016-07-22
- Marketing end
- 0000-00-00
- Substance
- CYCLOBENZAPRINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 |
|---|
| 53002-3080-1 | Cyclobenzaprine Hydrochloride | 5 in 1 BOTTLE | TABLET, FILM COATED | 5 | | 5 |
| 53002-3080-2 | Cyclobenzaprine Hydrochloride | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 5 |
| 53002-3080-3 | Cyclobenzaprine Hydrochloride | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 5 |
| 53002-3080-4 | Cyclobenzaprine Hydrochloride | 21 in 1 BOTTLE | TABLET, FILM COATED | 21 | | 5 |
| 53002-3080-5 | Cyclobenzaprine Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-3080 | CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE) TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 5 package rows | 20230609_2ff7cb40-9b43-47fb-a7b4-f9e6e9d65e5b.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 |
|---|
| 53002-3080-1 | 53002308001 | 5 TABLET, FILM COATED in 1 BOTTLE (53002-3080-1) | 2017-10-01 | 0000-00-00 | No | No | Current |
| 53002-3080-2 | 53002308002 | 10 TABLET, FILM COATED in 1 BOTTLE (53002-3080-2) | 2017-10-01 | 0000-00-00 | No | No | Current |
| 53002-3080-3 | 53002308003 | 15 TABLET, FILM COATED in 1 BOTTLE (53002-3080-3) | 2017-10-01 | 0000-00-00 | No | No | Current |
| 53002-3080-4 | 53002308004 | 21 TABLET, FILM COATED in 1 BOTTLE (53002-3080-4) | 2017-10-01 | 0000-00-00 | No | No | Current |
| 53002-3080-5 | 53002308005 | 30 TABLET, FILM COATED in 1 BOTTLE (53002-3080-5) | 2017-10-01 | 0000-00-00 | No | No | Current |