Cyclobenzaprine Hydrochloride
- Product NDC
- 45865-801
- 11-digit product format
- 458650801
- Labeler code
- 45865
- Product ID
- 45865-801_7dca1d1e-ce33-2025-e053-2a91aa0afdf3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cyclobenzaprine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- medsource pharmaceuticals
- Application
- ANDA077797
- Marketing category
- ANDA
- Marketing start
- 2017-03-30
- Marketing end
- 0000-00-00
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 45865-801-60 | Cyclobenzaprine Hydrochloride | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45865-801 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 2 | Legacy NDC, 1 package rows | 20181225_7dc9ffa8-9c80-b5a3-e053-2991aa0a5118.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 |
|---|
| 45865-801-60 | 45865080160 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (45865-801-60) | 2018-06-01 | 0000-00-00 | No | No | Current |