Cyclobenzaprine Hydrochloride
- Product NDC
- 45865-685
- 11-digit product format
- 458650685
- Labeler code
- 45865
- Product ID
- 45865-685_1f915bbb-93a2-6cfd-e054-00144ff8d46c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Medsource Pharmaceuticals
- Application
- ANDA078722
- Marketing category
- ANDA
- Marketing start
- 2011-08-29
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 45865-685-30 | Cyclobenzaprine Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 45865-685-40 | Cyclobenzaprine Hydrochloride | 40 in 1 BOTTLE | TABLET, FILM COATED | 40 | | 1 |
| 45865-685-45 | Cyclobenzaprine Hydrochloride | 45 in 1 BOTTLE | TABLET, FILM COATED | 45 | | 1 |
| 45865-685-51 | Cyclobenzaprine Hydrochloride | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 1 |
| 45865-685-60 | Cyclobenzaprine Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
| 45865-685-90 | Cyclobenzaprine Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
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 [MEDSOURCE PHARMACEUTICALS] | 1 | |
| CYCLOBENZAPRINE | ACTIVE MOIETY | 69O5WQQ5TI | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 1 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 1 | |
| STARCH, PREGELATINIZED CORN | INACTIVE INGREDIENT | O8232NY3SJ | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45865-685 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 1 | Legacy NDC, 6 package rows | 20150913_1f915bbb-93a1-6cfd-e054-00144ff8d46c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 45865-685-30 | 45865068530 | 30 in 1 BOTTLE | Historical |
| 45865-685-40 | 45865068540 | 40 in 1 BOTTLE | Historical |
| 45865-685-45 | 45865068545 | 45 in 1 BOTTLE | Historical |
| 45865-685-51 | 45865068551 | 120 in 1 BOTTLE | Historical |
| 45865-685-60 | 45865068560 | 60 in 1 BOTTLE | Historical |
| 45865-685-90 | 45865068590 | 90 in 1 BOTTLE | Historical |