Cyclobenzaprine Hydrochloride
- Product NDC
- 68071-3805
- 11-digit product format
- 680713805
- Labeler code
- 68071
- Product ID
- 68071-3805_4ece7809-ea40-8b06-e063-6394a90a72b6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3805-1 | Cyclobenzaprine Hydrochloride | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 3 |
| 68071-3805-2 | Cyclobenzaprine Hydrochloride | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 3 |
| 68071-3805-7 | Cyclobenzaprine Hydrochloride | 21 in 1 BOTTLE | TABLET, FILM COATED | 21 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3805 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.] | 2 | Current NDC, 3 package rows | 20250331_2f89c8f6-7f3c-8396-e063-6294a90a643e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3805-1 | 68071380501 | 15 TABLET, FILM COATED in 1 BOTTLE (68071-3805-1) | 2025-03-04 | No | No | Historical |
| 68071-3805-2 | 68071380502 | 20 TABLET, FILM COATED in 1 BOTTLE (68071-3805-2) | 2026-04-06 | No | No | Historical |
| 68071-3805-7 | 68071380507 | 21 TABLET, FILM COATED in 1 BOTTLE (68071-3805-7) | 2025-03-04 | No | No | Historical |