Cyclobenzaprine Hydrochloride
- Product NDC
- 70518-3764
- 11-digit product format
- 705183764
- Labeler code
- 70518
- Product ID
- 70518-3764_4f83668c-6485-2195-e063-6394a90a7bde
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA078643
- Marketing category
- ANDA
- Marketing start
- 2023-06-13
- 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 |
|---|
| 70518-3764-0 | Cyclobenzaprine Hydrochloride | 12 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 12 | | 7 |
| 70518-3764-1 | Cyclobenzaprine Hydrochloride | 14 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 14 | | 7 |
| 70518-3764-2 | Cyclobenzaprine Hydrochloride | 21 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 21 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3764 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.] | 4 | Current NDC, 3 package rows | 20250316_e4ed7ad2-cf58-4fdb-bc8c-d89f23b01210.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-3764-0 | 70518376400 | 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3764-0) | 2023-06-13 | No | No | Current |
| 70518-3764-1 | 70518376401 | 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3764-1) | 2024-03-05 | No | No | Current |
| 70518-3764-2 | 70518376402 | 21 in 1 BOTTLE, PLASTIC | | | | Historical |