Cyclobenzaprine Hydrochloride
- Product NDC
- 70518-4225
- 11-digit product format
- 705184225
- Labeler code
- 70518
- Product ID
- 70518-4225_4004e5c0-1ec3-9534-e063-6294a90a068a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA091281
- Marketing category
- ANDA
- Marketing start
- 2024-10-31
- 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 Hydrochloride
- 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 |
|---|
| 70518-4225-0 | Cyclobenzaprine Hydrochloride | 30 in 1 BOTTLE, PLASTIC | CAPSULE, EXTENDED RELEASE | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4225 | CYCLOBENZAPRINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REMEDYREPACK INC.] | 1 | Current NDC, 1 package rows | 20241102_ba659e1a-0091-45f6-b418-f4f36c9a2c79.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4225-0 | 70518422500 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4225-0) | 2024-10-31 | No | No | Historical |