Cyclobenzaprine Hydrochloride
- Product NDC
- 0093-3422
- 11-digit product format
- 000933422
- Labeler code
- 0093
- Product ID
- 0093-3422_43707f11-5cf5-46a1-af67-c12153c11fd1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA071611
- Marketing category
- ANDA
- Marketing start
- 2021-07-20
- 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
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CYCLOBENZAPRINE HYDROCHLORIDE | 10 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 |
|---|
| 0093-3422-01 | Cyclobenzaprine Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 5 |
| 0093-3422-05 | Cyclobenzaprine Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 5 |
| 0093-3422-10 | 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 |
|---|
| 0093-3422 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] | 4 | Current NDC, Legacy NDC, 3 package rows | 20241127_1d9e34cc-eee9-4147-abf8-c810a80e39d2.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 |
|---|
| 0093-3422-01 | 00093342201 | 100 TABLET, FILM COATED in 1 BOTTLE (0093-3422-01) | 2021-07-20 | 0000-00-00 | No | No | Current |
| 0093-3422-05 | 00093342205 | 500 TABLET, FILM COATED in 1 BOTTLE (0093-3422-05) | 2021-07-20 | 0000-00-00 | No | No | Current |
| 0093-3422-10 | 00093342210 | 1000 TABLET, FILM COATED in 1 BOTTLE (0093-3422-10) | 2021-07-20 | 0000-00-00 | No | No | Current |