Cyclobenzaprine HCL ER
- Product NDC
- 72189-389
- 11-digit product format
- 721890389
- Labeler code
- 72189
- Product ID
- 72189-389_2c4cd6df-c359-b1f7-e063-6394a90a9507
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine HCL ER
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- NDA021777
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2022-11-09
- Substance
- CYCLOBENZAPRINE HYDROCHLORIDE
- Active strength
- 15 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 HCL ER
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CYCLOBENZAPRINE HYDROCHLORIDE | 15 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0VE05JYS2P |
| Rxcui | 828358 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72189-389-60 | Cyclobenzaprine HCL ER | 60 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 60 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72189-389 | CYCLOBENZAPRINE HCL ER CAPSULE, EXTENDED RELEASE [DIRECT_RX] | 2 | Current NDC, Legacy NDC, 1 package rows | 20250123_ed0b9acc-132f-64c0-e053-2995a90a198c.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 |
|---|
| 72189-389-60 | 72189038960 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72189-389-60) | 2022-11-09 | 0000-00-00 | No | No | Current |