AMRIX
- Product NDC
- 21695-723
- 11-digit product format
- 216950723
- Labeler code
- 21695
- Product ID
- 21695-723_555ff988-280c-4272-bf1f-a911fe2e584d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Rebel Distributors Corp.
- Application
- NDA021777
- Marketing category
- NDA
- Marketing start
- 2007-10-01
- Marketing end
- 0000-00-00
- Substance
- CYCLOBENZAPRINE HYDROCHLORIDE
- Active strength
- 15 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 |
|---|
| 21695-723-14 | AMRIX | 14 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 14 | | 1 |
| 21695-723-28 | AMRIX | 28 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 28 | | 1 |
| 21695-723-60 | AMRIX | 60 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 60 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| cyclobenzaprine hydrochloride | ACTIVE INGREDIENT | 0VE05JYS2P | AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.] | 1 | |
| Cyclobenzaprine | ACTIVE MOIETY | 69O5WQQ5TI | AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.] | 1 | |
| diethyl phthalate | INACTIVE INGREDIENT | UF064M00AF | AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.] | 1 | |
| ETHYLCELLULOSES | INACTIVE INGREDIENT | 7Z8S9VYZ4B | AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.] | 1 | |
| FD&C GREEN NO. 3 | INACTIVE INGREDIENT | 3P3ONR6O1S | AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.] | 1 | |
| gelatin | INACTIVE INGREDIENT | 2G86QN327L | AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.] | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.] | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21695-723 | AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.] | 1 | Legacy NDC, 3 package rows | 20101210_555ff988-280c-4272-bf1f-a911fe2e584d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 21695-723-14 | 21695072314 | 14 in 1 BOTTLE | Historical |
| 21695-723-28 | 21695072328 | 28 in 1 BOTTLE | Historical |
| 21695-723-60 | 21695072360 | 60 in 1 BOTTLE | Historical |