Cyclobenzaprine Hydrochloride
- Product NDC
- 55700-762
- 11-digit product format
- 557000762
- Labeler code
- 55700
- Product ID
- 55700-762_e9960a9c-a7ce-4fd2-b12a-3f80ff18c5e0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Quality Care Products, LLC
- Application
- ANDA078722
- Marketing category
- ANDA
- Marketing start
- 2019-06-14
- Marketing end
- 0000-00-00
- Substance
- CYCLOBENZAPRINE HYDROCHLORIDE
- Active strength
- 8 mg/1
- Pharmacologic classes
- Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55700-762-01 | 2025-01-10 | C162847 | 48780-1 | 1030e365-690b-111a-e063-dadaa90a10e2 | 929d6a22-0ee8-4612-a5e9-ed52b815a252 |
| 55700-762-30 | 2025-01-10 | C162847 | 48780-1 | 1030e365-690b-111a-e063-dadaa90a10e2 | 929d6a22-0ee8-4612-a5e9-ed52b815a252 |
| 55700-762-60 | 2025-01-10 | C162847 | 48780-1 | 1030e365-690b-111a-e063-dadaa90a10e2 | 929d6a22-0ee8-4612-a5e9-ed52b815a252 |
| 55700-762-90 | 2025-01-10 | C162847 | 48780-1 | 1030e365-690b-111a-e063-dadaa90a10e2 | 929d6a22-0ee8-4612-a5e9-ed52b815a252 |
| 55700-762-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-690b-111a-e063-dadaa90a10e2 | 929d6a22-0ee8-4612-a5e9-ed52b815a252 |
| 55700-762-30 | 2024-01-30 | C162847 | 48780-1 | 1030e365-690b-111a-e063-dadaa90a10e2 | 929d6a22-0ee8-4612-a5e9-ed52b815a252 |
| 55700-762-60 | 2024-01-30 | C162847 | 48780-1 | 1030e365-690b-111a-e063-dadaa90a10e2 | 929d6a22-0ee8-4612-a5e9-ed52b815a252 |
| 55700-762-90 | 2024-01-30 | C162847 | 48780-1 | 1030e365-690b-111a-e063-dadaa90a10e2 | 929d6a22-0ee8-4612-a5e9-ed52b815a252 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55700-762-01 | EA - Each | 55700-762 | bde76e3a-14f8-4125-a04c-f8528a46f1ac | 1 | 2019-07-02 |
| 55700-762-30 | EA - Each | 55700-762 | f8f23f1b-e2bc-4b13-8514-1b0d3150bc9d | 1 | 2019-07-02 |
| 55700-762-60 | EA - Each | 55700-762 | a80b778f-4c71-4974-ac25-dd95e810f713 | 1 | 2019-07-02 |
| 55700-762-90 | EA - Each | 55700-762 | d0e72bea-ec64-4760-a5db-93612a023c1c | 1 | 2019-07-02 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 55700-762-01 | 55700076201 | 120 TABLET, FILM COATED in 1 BOTTLE (55700-762-01) | 2019-06-14 | 0000-00-00 | No | No | Current |
| 55700-762-30 | 55700076230 | 30 TABLET, FILM COATED in 1 BOTTLE (55700-762-30) | 2019-06-14 | 0000-00-00 | No | No | Current |
| 55700-762-60 | 55700076260 | 60 TABLET, FILM COATED in 1 BOTTLE (55700-762-60) | 2019-06-14 | 0000-00-00 | No | No | Current |
| 55700-762-90 | 55700076290 | 90 TABLET, FILM COATED in 1 BOTTLE (55700-762-90) | 2019-06-14 | 0000-00-00 | No | No | Current |