CYCLOBENZAPRINE HYROCHLORIDE
- Product NDC
- 76519-1000
- 11-digit product format
- 765191000
- Labeler code
- 76519
- Product ID
- 76519-1000_1987e93d-951f-4738-af92-6196f753d121
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CYCLOBENZAPRINE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- H.J. Harkins Company, Inc.
- 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
- 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 |
|---|
| 76519-1000-1 | CYCLOBENZAPRINE HYROCHLORIDE | 10 in 1 BOTTLE | TABLET | 10 | | 2 |
| 76519-1000-2 | CYCLOBENZAPRINE HYROCHLORIDE | 20 in 1 BOTTLE | TABLET | 20 | | 2 |
| 76519-1000-3 | CYCLOBENZAPRINE HYROCHLORIDE | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
| 76519-1000-5 | CYCLOBENZAPRINE HYROCHLORIDE | 15 in 1 BOTTLE | TABLET | 15 | | 2 |
| 76519-1000-6 | CYCLOBENZAPRINE HYROCHLORIDE | 60 in 1 BOTTLE | TABLET | 60 | | 2 |
| 76519-1000-7 | CYCLOBENZAPRINE HYROCHLORIDE | 120 in 1 BOTTLE | TABLET | 120 | | 2 |
| 76519-1000-9 | CYCLOBENZAPRINE HYROCHLORIDE | 90 in 1 BOTTLE | TABLET | 90 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CYCLOBENZAPRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 0VE05JYS2P | CYCLOBENZAPRINE HYROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [H.J. HARKINS COMPANY, INC.] | 2 | |
| CYCLOBENZAPRINE | ACTIVE MOIETY | 69O5WQQ5TI | CYCLOBENZAPRINE HYROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [H.J. HARKINS COMPANY, INC.] | 2 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | CYCLOBENZAPRINE HYROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [H.J. HARKINS COMPANY, INC.] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CYCLOBENZAPRINE HYROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [H.J. HARKINS COMPANY, INC.] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | CYCLOBENZAPRINE HYROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [H.J. HARKINS COMPANY, INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CYCLOBENZAPRINE HYROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [H.J. HARKINS COMPANY, INC.] | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | CYCLOBENZAPRINE HYROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [H.J. HARKINS COMPANY, INC.] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | CYCLOBENZAPRINE HYROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [H.J. HARKINS COMPANY, INC.] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | CYCLOBENZAPRINE HYROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [H.J. HARKINS COMPANY, INC.] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CYCLOBENZAPRINE HYROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [H.J. HARKINS COMPANY, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76519-1000 | CYCLOBENZAPRINE HYROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [H.J. HARKINS COMPANY, INC.] | 2 | Legacy NDC, 7 package rows | 20120405_884b2f1f-ba7c-4218-b7b8-d4bd3f56482e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 76519-1000-1 | 76519100001 | 10 in 1 BOTTLE | Historical |
| 76519-1000-2 | 76519100002 | 20 in 1 BOTTLE | Historical |
| 76519-1000-3 | 76519100003 | 30 in 1 BOTTLE | Historical |
| 76519-1000-5 | 76519100005 | 15 in 1 BOTTLE | Historical |
| 76519-1000-6 | 76519100006 | 60 in 1 BOTTLE | Historical |
| 76519-1000-7 | 76519100007 | 120 in 1 BOTTLE | Historical |
| 76519-1000-9 | 76519100009 | 90 in 1 BOTTLE | Historical |