Cyclobenzaprine hydrochloride
- Product NDC
- 29300-414
- 11-digit product format
- 293000414
- Labeler code
- 29300
- Product ID
- 29300-414_cc113cd6-8904-4485-b1b2-15dd5ff7468b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Unichem Pharmaceuticals (USA), Inc.
- 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, 828320, 828348 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 29300-414-01 | Cyclobenzaprine hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 5 |
| 29300-414-10 | Cyclobenzaprine hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 29300-414 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20230105_1adcdd8a-30f9-4a7b-853c-948a5589acab.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 |
|---|
| 29300-414-01 | 29300041401 | 100 TABLET, FILM COATED in 1 BOTTLE (29300-414-01) | 2020-09-30 | 0000-00-00 | No | No | Current |
| 29300-414-10 | 29300041410 | 1000 TABLET, FILM COATED in 1 BOTTLE (29300-414-10) | 2020-09-30 | 0000-00-00 | No | No | Current |