Cyclobenzaprine Hydrochloride
- Product NDC
- 70934-063
- 11-digit product format
- 709340063
- Labeler code
- 70934
- Product ID
- 70934-063_b8a74629-4bdd-ab84-e053-2a95a90aace1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cyclobenzaprine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Denton Pharma, Inc.
- Application
- ANDA077797
- Marketing category
- ANDA
- Marketing start
- 2018-01-15
- 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
- 2022-12-31
- 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 |
|---|
| 70934-063-15 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-5cca-a910-e053-dadaa90a0b85 | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
| 70934-063-20 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-5cca-a910-e053-dadaa90a0b85 | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
| 70934-063-30 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-5cca-a910-e053-dadaa90a0b85 | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
| 70934-063-15 | 2021-01-31 | C162847 | 48780-1 | ba0f9c33-5cca-a910-e053-dadaa90a0b85 | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
| 70934-063-20 | 2021-01-31 | C162847 | 48780-1 | ba0f9c33-5cca-a910-e053-dadaa90a0b85 | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
| 70934-063-30 | 2021-01-31 | C162847 | 48780-1 | ba0f9c33-5cca-a910-e053-dadaa90a0b85 | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
| 70934-063-15 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-5cca-a910-e053-dadaa90a0b85 | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
| 70934-063-20 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-5cca-a910-e053-dadaa90a0b85 | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
| 70934-063-30 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-5cca-a910-e053-dadaa90a0b85 | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70934-063-15 | Cyclobenzaprine Hydrochloride | 15 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 15 | | 6 |
| 70934-063-20 | Cyclobenzaprine Hydrochloride | 20 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 20 | | 6 |
| 70934-063-30 | Cyclobenzaprine Hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70934-063 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DENTON PHARMA, INC.] | 6 | Legacy NDC, 3 package rows | 20210201_643c0b19-01c9-e477-e053-2a91aa0a529c.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 |
|---|
| 70934-063-15 | 70934006315 | 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-063-15) | 2018-06-20 | 0000-00-00 | No | No | Current |
| 70934-063-20 | 70934006320 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-063-20) | 2018-05-25 | 0000-00-00 | No | No | Current |
| 70934-063-30 | 70934006330 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-063-30) | 2018-01-15 | 0000-00-00 | No | No | Current |