Cyclobenzaprine hydrochloride
- Product NDC
- 70518-3702
- 11-digit product format
- 705183702
- Labeler code
- 70518
- Product ID
- 70518-3702_4f8027eb-ec82-92ed-e063-6294a90a52b1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA213324
- Marketing category
- ANDA
- Marketing start
- 2023-04-06
- 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 | 828348 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-3702-0 | Cyclobenzaprine hydrochloride | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 9 |
| 70518-3702-1 | Cyclobenzaprine hydrochloride | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 9 |
| 70518-3702-2 | Cyclobenzaprine hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 9 |
| 70518-3702-3 | Cyclobenzaprine hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3702 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.] | 5 | Current NDC, 4 package rows | 20241027_51d85ea8-8317-4a76-a108-20383f118ad4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-3702-0 | 70518370200 | 60 in 1 BOTTLE, PLASTIC | | | | Historical |
| 70518-3702-1 | 70518370201 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3702-1) | 2023-04-12 | No | No | Historical |
| 70518-3702-2 | 70518370202 | 90 in 1 BOTTLE, PLASTIC | | | | Historical |
| 70518-3702-3 | 70518370203 | 30 in 1 BOTTLE, PLASTIC | | | | Historical |