CYCLOBENZAPRINE HYDROCHLORIDE
- Product NDC
- 51655-539
- 11-digit product format
- 516550539
- Labeler code
- 51655
- Product ID
- 51655-539_494dea9c-f9af-2eec-e063-6294a90ab96f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cyclobenzaprine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA208170
- Marketing category
- ANDA
- Marketing start
- 2021-01-14
- 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 |
|---|
| 51655-539-20 | CYCLOBENZAPRINE HYDROCHLORIDE | 20 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 20 | | 2 |
| 51655-539-52 | CYCLOBENZAPRINE HYDROCHLORIDE | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 2 |
| 51655-539-53 | CYCLOBENZAPRINE HYDROCHLORIDE | 10 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 10 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-539 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS] | 1 | Current NDC, 3 package rows | 20230328_dae3be94-a40c-5be1-e053-2a95a90a1484.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 51655-539-20 | 51655053920 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-539-20) | 2021-01-14 | No | No | Current |
| 51655-539-52 | 51655053952 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-539-52) | 2021-05-26 | No | No | Current |
| 51655-539-53 | 51655053953 | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-539-53) | 2022-04-15 | No | No | Current |