Cyclobenzaprine Hydrochloride
- Product NDC
- 0440-1350
- 11-digit product format
- 004401350
- Labeler code
- 0440
- Product ID
- 0440-1350_1ee65ac1-c6be-403f-bd22-0e3d72227937
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Liberty Pharmaceuticals, Inc.
- Application
- ANDA071611
- Marketing category
- ANDA
- Marketing start
- 1989-05-03
- Marketing end
- 0000-00-00
- Substance
- CYCLOBENZAPRINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- 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 |
|---|
| 0440-1350-09 | Cyclobenzaprine Hydrochloride | 9 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 9 | | 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 [LIBERTY PHARMACEUTICALS, INC.] | 1 | |
| CYCLOBENZAPRINE | ACTIVE MOIETY | 69O5WQQ5TI | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.] | 1 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.] | 1 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0440-1350 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.] | 1 | Legacy NDC, 1 package rows | 20130909_4636827c-a0cf-46e3-a682-08a19021be11.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 0440-1350-09 | 00440135009 | 9 in 1 BOTTLE, PLASTIC | Historical |