Cyclobenzaprine Hydrochloride
- Product NDC
- 71610-907
- 11-digit product format
- 716100907
- Labeler code
- 71610
- Product ID
- 71610-907_37b2aadd-c544-9ecf-e063-6394a90a2cb0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA077563
- Marketing category
- ANDA
- Marketing start
- 2020-04-03
- 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 |
|---|
| 71610-907-45 | Cyclobenzaprine Hydrochloride | 45 in 1 BOTTLE | TABLET, FILM COATED | 45 | | 2 |
| 71610-907-53 | Cyclobenzaprine Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-907 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ] | 1 | Current NDC, 2 package rows | 20250515_34f4e63a-1259-0226-e063-6294a90a9fc4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-907-45 | 71610090745 | 45 TABLET, FILM COATED in 1 BOTTLE (71610-907-45) | 2025-05-08 | No | No | Historical |
| 71610-907-53 | 71610090753 | 60 TABLET, FILM COATED in 1 BOTTLE (71610-907-53) | 2025-06-13 | No | No | Historical |