Cyclobenzaprine Hydrochloride
- Product NDC
- 71085-010
- 11-digit product format
- 710850010
- Labeler code
- 71085
- Product ID
- 71085-010_f7821fc7-c11b-465e-9d33-a399e09926ae
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- IPG PHARMACEUTICALS, INC.
- Application
- ANDA078722
- Marketing category
- ANDA
- Marketing start
- 2017-08-01
- 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
- 2019-12-31
- 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 |
|---|---|---|---|---|---|
| 71085-010-01 | 2024-12-04 | C162847 | 48780-1 | 9d75b9cf-dc6a-f424-e053-dadaa90a57ce | f7821fc7-c11b-465e-9d33-a399e09926ae |
| 71085-010-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-dc6a-f424-e053-dadaa90a57ce | f7821fc7-c11b-465e-9d33-a399e09926ae |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71085-010-01 | EA - Each | 71085-010 | f08b2ca1-5b94-4dd7-918b-3711bc964255 | 1 | 2017-08-11 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 828299 | cyclobenzaprine HCl 7.5 MG Oral Tablet | PSN | a4f851e5-ef99-4a09-b120-5f9c874f7143 | 2 |
| 828299 | cyclobenzaprine hydrochloride 7.5 MG Oral Tablet | SCD | a4f851e5-ef99-4a09-b120-5f9c874f7143 | 2 |