Cyclobenzaprine Hydrochloride
- Product NDC
- 60687-558
- 11-digit product format
- 606870558
- Labeler code
- 60687
- Product ID
- 60687-558_437e4fe5-baf0-1534-e063-6394a90a22d4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA090478
- Marketing category
- ANDA
- Marketing start
- 2022-02-10
- 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
- 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0VE05JYS2P |
| Rxcui | 828348 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60687-558-01 | Cyclobenzaprine Hydrochloride | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 4 |
| 60687-558-11 | Cyclobenzaprine Hydrochloride | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60687-558 | CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240417_269bc278-963d-4830-816a-39bb4bf8c936.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 60687-558-01 | 60687055801 | 100 BLISTER PACK in 1 CARTON (60687-558-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-558-11) | 100 blister pack | 2022-02-10 | 0000-00-00 | No | No | Current |
| 60687-558-11 | 60687055811 | 1 in 1 BLISTER PACK | | | | | | Historical |