Cyclobenzaprine Hydrochloride
- Product NDC
- 67544-251
- 11-digit product format
- 675440251
- Labeler code
- 67544
- Product ID
- 67544-251_41c6e9d2-bc3f-492e-b855-0acc742ebdeb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- 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
- No
- Listing certified through
- 2020-12-31
- 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 |
|---|
| 67544-251-15 | Cyclobenzaprine Hydrochloride | 15 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 15 | | 2 |
| 67544-251-30 | Cyclobenzaprine Hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 2 |
| 67544-251-45 | Cyclobenzaprine Hydrochloride | 45 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 45 | | 2 |
| 67544-251-53 | Cyclobenzaprine Hydrochloride | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 2 |
| 67544-251-60 | Cyclobenzaprine Hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 2 |
| 67544-251-70 | Cyclobenzaprine Hydrochloride | 120 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 120 | | 2 |
| 67544-251-80 | Cyclobenzaprine Hydrochloride | 180 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 180 | | 2 |
| 67544-251-92 | Cyclobenzaprine Hydrochloride | 270 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 270 | | 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 [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| CYCLOBENZAPRINE | ACTIVE MOIETY | 69O5WQQ5TI | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67544-251 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | Legacy NDC, 8 package rows | 20191227_1d325ea3-fd3f-4cf7-9d07-d5144e7945f5.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 |
|---|
| 67544-251-15 | 67544025115 | 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-251-15) | 2008-05-05 | 0000-00-00 | No | No | Current |
| 67544-251-30 | 67544025130 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-251-30) | 2007-01-10 | 0000-00-00 | No | No | Current |
| 67544-251-45 | 67544025145 | 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-251-45) | 2009-10-19 | 0000-00-00 | No | No | Current |
| 67544-251-53 | 67544025153 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-251-53) | 2009-03-09 | 0000-00-00 | No | No | Current |
| 67544-251-60 | 67544025160 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-251-60) | 2008-10-17 | 0000-00-00 | No | No | Current |
| 67544-251-70 | 67544025170 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-251-70) | 2012-09-26 | 0000-00-00 | No | No | Current |
| 67544-251-80 | 67544025180 | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-251-80) | 2009-10-19 | 0000-00-00 | No | No | Current |
| 67544-251-92 | 67544025192 | 270 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-251-92) | 2009-03-09 | 0000-00-00 | No | No | Current |