Cyclobenzaprine Hydrochloride
- Product NDC
- 68084-753
- 11-digit product format
- 680840753
- Labeler code
- 68084
- Product ID
- 68084-753_292934aa-0e3e-af97-e063-6394a90ae5b4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA078048
- Marketing category
- ANDA
- Marketing start
- 2016-01-04
- Substance
- CYCLOBENZAPRINE HYDROCHLORIDE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cyclobenzaprine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CYCLOBENZAPRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0VE05JYS2P |
| Rxcui | 828320 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68084-753-11 | Cyclobenzaprine Hydrochloride | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 9 |
| 68084-753-25 | Cyclobenzaprine Hydrochloride | 30 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 30 | | 9 |
| 68084-753-65 | Cyclobenzaprine Hydrochloride | 50 in 1 CARTON | TABLET, FILM COATED | 50 | | 9 |
| 68084-753-95 | Cyclobenzaprine Hydrochloride | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68084-753 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 9 | Current NDC, Legacy NDC, 4 package rows | 20241215_5f321a03-ccfb-4c11-ac60-a461a5580c69.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68084-753-11 | 68084075311 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 68084-753-25 | 68084075325 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-753-25) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-753-95) | 30 blister pack | 2016-01-04 | 0000-00-00 | No | No | Current |
| 68084-753-65 | 68084075365 | 50 BLISTER PACK in 1 CARTON (68084-753-65) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-753-11) | 50 blister pack | 2024-03-27 | | No | No | Current |
| 68084-753-95 | 68084075395 | 1 in 1 BLISTER PACK | | | | | | Historical |