Cyclobenzaprine Hydrochloride
- Product NDC
- 68071-1961
- 11-digit product format
- 680711961
- Labeler code
- 68071
- Product ID
- 68071-1961_bc05dccd-72ce-1673-e053-2a95a90a1d9b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA078722
- Marketing category
- ANDA
- Marketing start
- 2015-03-25
- 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
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 68071-1961-1 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-152a-a910-e053-dadaa90a0b85 | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
| 68071-1961-2 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-152a-a910-e053-dadaa90a0b85 | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
| 68071-1961-3 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-152a-a910-e053-dadaa90a0b85 | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
| 68071-1961-6 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-152a-a910-e053-dadaa90a0b85 | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
| 68071-1961-9 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-152a-a910-e053-dadaa90a0b85 | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
| 68071-1961-1 | 2021-02-23 | C162847 | 48780-1 | ba0f9c33-152a-a910-e053-dadaa90a0b85 | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
| 68071-1961-2 | 2021-02-23 | C162847 | 48780-1 | ba0f9c33-152a-a910-e053-dadaa90a0b85 | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
| 68071-1961-3 | 2021-02-23 | C162847 | 48780-1 | ba0f9c33-152a-a910-e053-dadaa90a0b85 | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
| 68071-1961-6 | 2021-02-23 | C162847 | 48780-1 | ba0f9c33-152a-a910-e053-dadaa90a0b85 | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
| 68071-1961-9 | 2021-02-23 | C162847 | 48780-1 | ba0f9c33-152a-a910-e053-dadaa90a0b85 | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
| 68071-1961-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-152a-a910-e053-dadaa90a0b85 | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
| 68071-1961-2 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-152a-a910-e053-dadaa90a0b85 | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
| 68071-1961-3 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-152a-a910-e053-dadaa90a0b85 | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
| 68071-1961-6 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-152a-a910-e053-dadaa90a0b85 | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
| 68071-1961-9 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-152a-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 |
|---|
| 68071-1961-1 | Cyclobenzaprine Hydrochloride | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 3 |
| 68071-1961-2 | Cyclobenzaprine Hydrochloride | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 3 |
| 68071-1961-3 | Cyclobenzaprine Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
| 68071-1961-6 | Cyclobenzaprine Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 3 |
| 68071-1961-9 | Cyclobenzaprine Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-1961 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.] | 3 | Legacy NDC, 5 package rows | 20210224_492392c0-682f-2131-e054-00144ff8d46c.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 |
|---|
| 68071-1961-1 | 68071196101 | 15 TABLET, FILM COATED in 1 BOTTLE (68071-1961-1) | 2017-02-22 | 0000-00-00 | No | No | Current |
| 68071-1961-2 | 68071196102 | 20 TABLET, FILM COATED in 1 BOTTLE (68071-1961-2) | 2017-02-22 | 0000-00-00 | No | No | Current |
| 68071-1961-3 | 68071196103 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-1961-3) | 2017-02-22 | 0000-00-00 | No | No | Current |
| 68071-1961-6 | 68071196106 | 60 TABLET, FILM COATED in 1 BOTTLE (68071-1961-6) | 2017-02-22 | 0000-00-00 | No | No | Current |
| 68071-1961-9 | 68071196109 | 90 TABLET, FILM COATED in 1 BOTTLE (68071-1961-9) | 2017-02-22 | 0000-00-00 | No | No | Current |