Cyclobenzaprine Hydrochloride
- Product NDC
- 69336-104
- 11-digit product format
- 693360104
- Labeler code
- 69336
- Product ID
- 69336-104_e49e22dc-5660-4d54-8a62-d0e04a7f1a99
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- CAPSULE, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Sterling Knight Pharmaceuticals,LLC
- Application
- ANDA078218
- Marketing category
- ANDA
- Marketing start
- 2016-11-03
- 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
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 69336-104-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-de5c-f424-e053-dadaa90a57ce | CYCLOBENZAPRINE HYDROCHLORIDE- cyclobenzaprine hydrochloride tablet, film coated Sterling-Knight Pharmaceuticals, LLC Cyclobenzaprine Hydrochloride Tablets , USP Rx only |
| 69336-104-11 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-de5c-f424-e053-dadaa90a57ce | CYCLOBENZAPRINE HYDROCHLORIDE- cyclobenzaprine hydrochloride tablet, film coated Sterling-Knight Pharmaceuticals, LLC Cyclobenzaprine Hydrochloride Tablets , USP Rx only |
| 69336-104-50 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-de5c-f424-e053-dadaa90a57ce | CYCLOBENZAPRINE HYDROCHLORIDE- cyclobenzaprine hydrochloride tablet, film coated Sterling-Knight Pharmaceuticals, LLC Cyclobenzaprine Hydrochloride Tablets , USP Rx only |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69336-104-10 | Cyclobenzaprine Hydrochloride | 100 in 1 BOTTLE | CAPSULE, FILM COATED, EXTENDED R | 100 | | 6 |
| 69336-104-11 | Cyclobenzaprine Hydrochloride | 1000 in 1 BOTTLE | CAPSULE, FILM COATED, EXTENDED R | 1000 | | 6 |
| 69336-104-50 | Cyclobenzaprine Hydrochloride | 500 in 1 BOTTLE | CAPSULE, FILM COATED, EXTENDED R | 500 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69336-104 | CYCLOBENZAPRINE HYDROCHLORIDE CAPSULE, FILM COATED, EXTENDED RELEASE [STERLING KNIGHT PHARMACEUTICALS,LLC] | 6 | Legacy NDC, 3 package rows | 20161114_9312079f-4bef-4d2a-ba8a-62c94145a4e5.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 69336-104-10 | 69336010410 | 100 in 1 BOTTLE | Historical |
| 69336-104-11 | 69336010411 | 1000 in 1 BOTTLE | Historical |
| 69336-104-50 | 69336010450 | 500 in 1 BOTTLE | Historical |