Cyclobenzaprine hydrochloride
- Product NDC
- 60760-780
- 11-digit product format
- 607600780
- Labeler code
- 60760
- Product ID
- 60760-780_446e3701-c7d4-d867-e063-6394a90a6326
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- ST. MARY'S MEDICAL PARK PHARMACY
- Application
- ANDA213324
- Marketing category
- ANDA
- Marketing start
- 2020-07-06
- Substance
- CYCLOBENZAPRINE HYDROCHLORIDE
- Active strength
- 7.5 mg/1
- Pharmacologic classes
- Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cyclobenzaprine hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CYCLOBENZAPRINE HYDROCHLORIDE | 7.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0VE05JYS2P |
| Rxcui | 828299 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60760-780-30 | Cyclobenzaprine hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 3 |
| 60760-780-60 | Cyclobenzaprine hydrochloride | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 3 |
| 60760-780-90 | Cyclobenzaprine hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 3 |
| 60760-780-92 | Cyclobenzaprine hydrochloride | 120 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 120 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60760-780 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY] | 2 | Current NDC, 4 package rows | 20240511_16ed7d7e-862f-db36-e063-6394a90a02a5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 60760-780-30 | 60760078030 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-780-30) | 2024-05-08 | No | No | Current |
| 60760-780-60 | 60760078060 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-780-60) | 2024-05-08 | No | No | Current |
| 60760-780-90 | 60760078090 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-780-90) | 2024-04-09 | No | No | Current |
| 60760-780-92 | 60760078092 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-780-92) | 2024-04-16 | No | No | Current |