Cyclobenzaprine Hydrochloride
- Product NDC
- 71800-003
- 11-digit product format
- 718000003
- Labeler code
- 71800
- Product ID
- 71800-003_d24f06f7-d248-48ea-8b30-5f617f7cdf7e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Innovida Pharmaceutique Corporation
- Application
- ANDA078722
- Marketing category
- ANDA
- Marketing start
- 2018-01-16
- 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 51048710-225c-aa41-d0e7-eed095d02838 | Product name | 4 | 20250331 |
| c2c26dc9-7e16-fc02-7eba-6b46ed3515ee | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 71800-003-01 | 2025-01-09 | C162847 | 48780-1 | ab0e2407-3376-f274-e053-dbdaa90a6471 | 19dd144a-db95-47f2-8e91-a1239a475fc1 |
| 71800-003-01 | 2023-01-30 | C162847 | 48780-1 | ab0e2407-3376-f274-e053-dbdaa90a6471 | 19dd144a-db95-47f2-8e91-a1239a475fc1 |
| 71800-003-01 | 2020-10-02 | C162847 | 48780-1 | ab0e2407-3376-f274-e053-dbdaa90a6471 | 19dd144a-db95-47f2-8e91-a1239a475fc1 |
| 71800-003-01 | 2020-09-27 | C162847 | 48780-1 | ab0e2407-3376-f274-e053-dbdaa90a6471 | 19dd144a-db95-47f2-8e91-a1239a475fc1 |
| 71800-003-01 | 2020-09-25 | C162847 | 48780-1 | ab0e2407-3376-f274-e053-dbdaa90a6471 | 19dd144a-db95-47f2-8e91-a1239a475fc1 |
| 71800-003-01 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-3376-f274-e053-dbdaa90a6471 | 19dd144a-db95-47f2-8e91-a1239a475fc1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71800-003-01 | EA - Each | 71800-003 | 6caa66dd-e51e-4973-b03a-f172ef7093be | 1 | 2018-02-20 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 828320 | cyclobenzaprine HCl 5 MG Oral Tablet | PSN | 858d10e7-dfe5-4c4f-e053-2a91aa0a783e | 12 |
| 828299 | cyclobenzaprine HCl 7.5 MG Oral Tablet | PSN | 858d10e7-dfe5-4c4f-e053-2a91aa0a783e | 12 |
| 828320 | cyclobenzaprine hydrochloride 5 MG Oral Tablet | SCD | 858d10e7-dfe5-4c4f-e053-2a91aa0a783e | 12 |
| 828299 | cyclobenzaprine hydrochloride 7.5 MG Oral Tablet | SCD | 858d10e7-dfe5-4c4f-e053-2a91aa0a783e | 12 |
| 828299 | cyclobenzaprine HCl 7.5 MG Oral Tablet | PSN | 64669718-02a0-47c6-9709-5f8db5736e04 | 3 |
| 828299 | cyclobenzaprine hydrochloride 7.5 MG Oral Tablet | SCD | 64669718-02a0-47c6-9709-5f8db5736e04 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 71800-003-01 | 71800000301 | 1000 TABLET, FILM COATED in 1 BOTTLE (71800-003-01) | 2018-01-16 | 0000-00-00 | No | No | Current |