Cyclobenzaprine Hydrochloride
- Product NDC
- 72603-311
- 11-digit product format
- 726030311
- Labeler code
- 72603
- Product ID
- 72603-311_4764d2fb-f80d-1435-e063-6294a90acd0b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NORTHSTAR RX LLC
- Application
- ANDA208170
- Marketing category
- ANDA
- Marketing start
- 2017-05-31
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cyclobenzaprine Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CYCLOBENZAPRINE HYDROCHLORIDE | 7.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0VE05JYS2P |
| Rxcui | 828299, 828320, 828348 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72603-311-01 | Cyclobenzaprine Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72603-311 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] | 1 | Current NDC, 1 package rows | 20241031_2a3a13c3-116c-4e9e-a7f3-7ad7c80486c3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72603-311-01 | 72603031101 | 100 TABLET, FILM COATED in 1 BOTTLE (72603-311-01) | 2024-11-01 | No | No | Current |