CYCLOBENZAPRINE HYDROCHLORIDE
- Product NDC
- 61919-261
- 11-digit product format
- 619190261
- Labeler code
- 61919
- Product ID
- 61919-261_b8555ee4-3de9-d01a-e053-2995a90a478c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CYCLOBENZAPRINE HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA078722
- Marketing category
- ANDA
- Marketing start
- 2019-08-16
- 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61919-261-15 | CYCLOBENZAPRINE HYDROCHLORIDE | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 5 |
| 61919-261-30 | CYCLOBENZAPRINE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 61919-261-60 | CYCLOBENZAPRINE HYDROCHLORIDE | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 2 |
| 61919-261-72 | CYCLOBENZAPRINE HYDROCHLORIDE | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 2 |
| 61919-261-90 | CYCLOBENZAPRINE HYDROCHLORIDE | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CYCLOBENZAPRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 0VE05JYS2P | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] | 2 | |
| CYCLOBENZAPRINE | ACTIVE MOIETY | 69O5WQQ5TI | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] | 2 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61919-261 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT_RX] | 5 | Legacy NDC, 1 package rows | 20230125_903e3a5a-7c58-b70d-e053-2a95a90a6f9d.zip |
| 61919-261 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] | 2 | Legacy NDC, 4 package rows | 20150810_ded16433-2462-4fec-8de7-2aed82f55f40.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 |
|---|
| 61919-261-15 | 61919026115 | 15 TABLET, FILM COATED in 1 BOTTLE (61919-261-15) | 2019-08-16 | 0000-00-00 | No | No | Current |
| 61919-261-30 | 61919026130 | 30 in 1 BOTTLE | | | | | Historical |
| 61919-261-60 | 61919026160 | 60 in 1 BOTTLE | | | | | Historical |
| 61919-261-72 | 61919026172 | 120 in 1 BOTTLE | | | | | Historical |
| 61919-261-90 | 61919026190 | 90 in 1 BOTTLE | | | | | Historical |