CYCLOBENZAPRINE HYDROCHLORIDE
- Product NDC
- 67296-1621
- 11-digit product format
- 672961621
- Labeler code
- 67296
- Product ID
- 67296-1621_d61d3545-f923-85c1-e053-2995a90aff61
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cyclobenzaprine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- RedPharm Drug, Inc.
- Application
- ANDA208170
- Marketing category
- ANDA
- Marketing start
- 2018-01-01
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- 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 |
|---|
| 67296-1621-1 | 2026-01-29 | C162847 | 48780-1 | 1030e365-530f-111a-e063-dadaa90a10e2 | Cyclobenzaprine hydrochloride, USP |
| 67296-1621-3 | 2026-01-29 | C162847 | 48780-1 | 1030e365-530f-111a-e063-dadaa90a10e2 | Cyclobenzaprine hydrochloride, USP |
| 67296-1621-5 | 2026-01-29 | C162847 | 48780-1 | 1030e365-530f-111a-e063-dadaa90a10e2 | Cyclobenzaprine hydrochloride, USP |
| 67296-1621-7 | 2026-01-29 | C162847 | 48780-1 | 1030e365-530f-111a-e063-dadaa90a10e2 | Cyclobenzaprine hydrochloride, USP |
| 67296-1621-1 | 2024-08-15 | C162847 | 48780-1 | 1030e365-530f-111a-e063-dadaa90a10e2 | Cyclobenzaprine hydrochloride, USP |
| 67296-1621-3 | 2024-08-15 | C162847 | 48780-1 | 1030e365-530f-111a-e063-dadaa90a10e2 | Cyclobenzaprine hydrochloride, USP |
| 67296-1621-7 | 2024-08-15 | C162847 | 48780-1 | 1030e365-530f-111a-e063-dadaa90a10e2 | Cyclobenzaprine hydrochloride, USP |
| 67296-1621-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-530f-111a-e063-dadaa90a10e2 | Cyclobenzaprine hydrochloride, USP |
| 67296-1621-3 | 2024-01-30 | C162847 | 48780-1 | 1030e365-530f-111a-e063-dadaa90a10e2 | Cyclobenzaprine hydrochloride, USP |
| 67296-1621-7 | 2024-01-30 | C162847 | 48780-1 | 1030e365-530f-111a-e063-dadaa90a10e2 | Cyclobenzaprine hydrochloride, USP |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67296-1621-1 | CYCLOBENZAPRINE HYDROCHLORIDE | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 11 |
| 67296-1621-3 | CYCLOBENZAPRINE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 11 |
| 67296-1621-5 | CYCLOBENZAPRINE HYDROCHLORIDE | 5 in 1 BOTTLE | TABLET, FILM COATED | 5 | | 11 |
| 67296-1621-7 | CYCLOBENZAPRINE HYDROCHLORIDE | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67296-1621 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG, INC.] | 11 | Legacy NDC, 4 package rows | 20240816_7b246152-e7a7-228c-e053-2a91aa0ad863.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 |
|---|
| 67296-1621-1 | 67296162101 | 10 TABLET, FILM COATED in 1 BOTTLE (67296-1621-1) | 2018-01-01 | 0000-00-00 | No | No | Current |
| 67296-1621-3 | 67296162103 | 30 TABLET, FILM COATED in 1 BOTTLE (67296-1621-3) | 2018-01-01 | 0000-00-00 | No | No | Current |
| 67296-1621-5 | 67296162105 | 5 in 1 BOTTLE | | | | | Historical |
| 67296-1621-7 | 67296162107 | 15 TABLET, FILM COATED in 1 BOTTLE (67296-1621-7) | 2018-01-01 | 0000-00-00 | No | No | Current |