Cyclobenzaprine Hydrochloride
- Product NDC
- 0904-7401
- 11-digit product format
- 009047401
- Labeler code
- 0904
- Product ID
- 0904-7401_01d0daef-106b-4557-95d2-380a993ba9f1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA078643
- Marketing category
- ANDA
- Marketing start
- 2008-09-26
- Marketing end
- 2027-07-31
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cyclobenzaprine Hydrochloride
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CYCLOBENZAPRINE HYDROCHLORIDE | 10 mg/1 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-7401-61 | Cyclobenzaprine Hydrochloride | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 3 |
| 0904-7401-61 | Cyclobenzaprine Hydrochloride | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7401 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 1 | Current NDC, 2 package rows | 20240224_508e310e-067a-4f95-869a-e1da49aabe94.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0904-7401-61 | 00904740161 | 100 BLISTER PACK in 1 CARTON (0904-7401-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 100 blister pack | 2024-02-21 | No | No | Historical |