Cyclobenzaprine Hydrochloride
- Product NDC
- 72789-115
- 11-digit product format
- 727890115
- Labeler code
- 72789
- Product ID
- 72789-115_3416fd46-7b24-04d7-e063-6294a90ae444
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cyclobenzaprine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA077797
- Marketing category
- ANDA
- Marketing start
- 2017-03-30
- 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
- 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 | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0VE05JYS2P |
| Rxcui | 828320 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72789-115-10 | Cyclobenzaprine Hydrochloride | 10 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 10 | | 9 |
| 72789-115-20 | Cyclobenzaprine Hydrochloride | 20 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 20 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-115 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 9 | Current NDC, Legacy NDC, 2 package rows | 20250503_59b428fa-5013-4b2b-872f-16ba4a9d4f5d.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 |
|---|
| 72789-115-10 | 72789011510 | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-115-10) | 2020-09-14 | 0000-00-00 | No | No | Current |
| 72789-115-20 | 72789011520 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-115-20) | 2021-01-19 | 0000-00-00 | No | No | Current |