Cyclobenzaprine Hydrochloride
- Product NDC
- 43547-399
- 11-digit product format
- 435470399
- Labeler code
- 43547
- Product ID
- 43547-399_0318717e-68e2-48bc-aa86-d34101d2bd25
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cyclobenzaprine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Solco Healthcare U.S., LLC
- Application
- ANDA077797
- Marketing category
- ANDA
- Marketing start
- 2017-03-30
- Substance
- CYCLOBENZAPRINE HYDROCHLORIDE
- Active strength
- 5 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 | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0VE05JYS2P |
| Rxcui | 828320, 828348 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 43547-399-01 | 2020-03-05 | C162847 | 48780-1 | 9d75b9d1-058b-f424-e053-dadaa90a57ce | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
| 43547-399-10 | 2020-03-05 | C162847 | 48780-1 | 9d75b9d1-058b-f424-e053-dadaa90a57ce | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
| 43547-399-11 | 2020-03-05 | C162847 | 48780-1 | 9d75b9d1-058b-f424-e053-dadaa90a57ce | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
| 43547-399-50 | 2020-03-05 | C162847 | 48780-1 | 9d75b9d1-058b-f424-e053-dadaa90a57ce | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
| 43547-399-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-058b-f424-e053-dadaa90a57ce | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
| 43547-399-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-058b-f424-e053-dadaa90a57ce | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
| 43547-399-11 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-058b-f424-e053-dadaa90a57ce | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
| 43547-399-50 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-058b-f424-e053-dadaa90a57ce | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43547-399-01 | Cyclobenzaprine Hydrochloride | 10 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 10 | | 3 |
| 43547-399-10 | Cyclobenzaprine Hydrochloride | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 3 |
| 43547-399-11 | Cyclobenzaprine Hydrochloride | 1000 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 1000 | | 3 |
| 43547-399-50 | Cyclobenzaprine Hydrochloride | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 500 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43547-399 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC] | 3 | Current NDC, Legacy NDC, 4 package rows | 20250402_f558863b-ea3f-4e4b-85e9-edb2573e7151.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43547-399-01 | 43547039901 | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-399-01) | 2017-03-30 | 0000-00-00 | No | No | Current |
| 43547-399-10 | 43547039910 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-399-10) | 2017-03-30 | 0000-00-00 | No | No | Current |
| 43547-399-11 | 43547039911 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-399-11) | 2017-03-30 | 0000-00-00 | No | No | Current |
| 43547-399-50 | 43547039950 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-399-50) | 2017-03-30 | 0000-00-00 | No | No | Current |