Cyclobenzaprine Hydrochloride
- Product NDC
- 53489-591
- 11-digit product format
- 534890591
- Labeler code
- 53489
- Product ID
- 53489-591_f31e2835-b272-4f87-bbc7-6cb4ec25fde9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mutual Pharmaceutical
- Application
- ANDA073541
- Marketing category
- ANDA
- Marketing start
- 1995-05-23
- 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 |
|---|
| 53489-591-01 | Cyclobenzaprine Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 4 |
| 53489-591-05 | Cyclobenzaprine Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 4 |
| 53489-591-07 | Cyclobenzaprine Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
| 53489-591-10 | Cyclobenzaprine Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 4 |
| 53489-591-60 | Cyclobenzaprine Hydrochloride | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 4 |
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 [MUTUAL PHARMACEUTICAL] | 4 | |
| Cyclobenzaprine | ACTIVE MOIETY | 69O5WQQ5TI | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL] | 4 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL] | 4 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL] | 4 | |
| lactose | INACTIVE INGREDIENT | J2B2A4N98G | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL] | 4 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL] | 4 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL] | 4 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL] | 4 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL] | 4 | |
| starch, corn | INACTIVE INGREDIENT | O8232NY3SJ | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL] | 4 | |
| CYCLOBENZAPRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 0VE05JYS2P | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| Cyclobenzaprine | ACTIVE MOIETY | 69O5WQQ5TI | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53489-591 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL] | 4 | Legacy NDC, 5 package rows | 20130514_ac490da0-6347-4f5d-bcae-c23261b43725.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53489-591-01 | 53489059101 | 100 in 1 BOTTLE | Historical |
| 53489-591-05 | 53489059105 | 500 in 1 BOTTLE | Historical |
| 53489-591-07 | 53489059107 | 30 in 1 BOTTLE | Historical |
| 53489-591-10 | 53489059110 | 1000 in 1 BOTTLE | Historical |
| 53489-591-60 | 53489059160 | 20 in 1 BOTTLE | Historical |