Cyclobenzaprine Hydrochloride
- Product NDC
- 10544-072
- 11-digit product format
- 105440072
- Labeler code
- 10544
- Product ID
- 10544-072_1313f0dc-5975-5ec7-e054-00144ff8d46c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA071611
- Marketing category
- ANDA
- Marketing start
- 2012-03-30
- 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
- 2017-12-31
- 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 |
|---|
| 10544-072-00 | Cyclobenzaprine Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 3 |
| 10544-072-02 | Cyclobenzaprine Hydrochloride | 2 in 1 BOTTLE | TABLET, FILM COATED | 2 | | 3 |
| 10544-072-09 | Cyclobenzaprine Hydrochloride | 9 in 1 BOTTLE | TABLET, FILM COATED | 9 | | 3 |
| 10544-072-10 | Cyclobenzaprine Hydrochloride | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 3 |
| 10544-072-14 | Cyclobenzaprine Hydrochloride | 14 in 1 BOTTLE | TABLET, FILM COATED | 14 | | 3 |
| 10544-072-15 | Cyclobenzaprine Hydrochloride | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 3 |
| 10544-072-20 | Cyclobenzaprine Hydrochloride | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 3 |
| 10544-072-21 | Cyclobenzaprine Hydrochloride | 21 in 1 BOTTLE | TABLET, FILM COATED | 21 | | 3 |
| 10544-072-30 | Cyclobenzaprine Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
| 10544-072-45 | Cyclobenzaprine Hydrochloride | 45 in 1 BOTTLE | TABLET, FILM COATED | 45 | | 3 |
| 10544-072-60 | Cyclobenzaprine Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 3 |
| 10544-072-84 | Cyclobenzaprine Hydrochloride | 84 in 1 BOTTLE | TABLET, FILM COATED | 84 | | 3 |
| 10544-072-90 | Cyclobenzaprine Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 3 |
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 [BLENHEIM PHARMACAL, INC.] | 3 | |
| CYCLOBENZAPRINE | ACTIVE MOIETY | 69O5WQQ5TI | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 3 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 3 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 3 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-072 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 3 | Legacy NDC, 13 package rows | 20150407_3d3179d3-e2f0-4d4f-aef6-dc18b26fd4a7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-072-00 | 10544007200 | 100 in 1 BOTTLE | Historical |
| 10544-072-02 | 10544007202 | 2 in 1 BOTTLE | Historical |
| 10544-072-09 | 10544007209 | 9 in 1 BOTTLE | Historical |
| 10544-072-10 | 10544007210 | 10 in 1 BOTTLE | Historical |
| 10544-072-14 | 10544007214 | 14 in 1 BOTTLE | Historical |
| 10544-072-15 | 10544007215 | 15 in 1 BOTTLE | Historical |
| 10544-072-20 | 10544007220 | 20 in 1 BOTTLE | Historical |
| 10544-072-21 | 10544007221 | 21 in 1 BOTTLE | Historical |
| 10544-072-30 | 10544007230 | 30 in 1 BOTTLE | Historical |
| 10544-072-45 | 10544007245 | 45 in 1 BOTTLE | Historical |
| 10544-072-60 | 10544007260 | 60 in 1 BOTTLE | Historical |
| 10544-072-84 | 10544007284 | 84 in 1 BOTTLE | Historical |
| 10544-072-90 | 10544007290 | 90 in 1 BOTTLE | Historical |