Cyclobenzaprine Hydrochloride
- Product NDC
- 63629-8206
- 11-digit product format
- 636298206
- Labeler code
- 63629
- Product ID
- 63629-8206_9883a891-91a6-4b0c-827d-59bc6b14b0ae
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- NDA021777
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2019-03-04
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-8206-1 | Cyclobenzaprine Hydrochloride | 30 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 30 | | 5 |
| 63629-8206-2 | Cyclobenzaprine Hydrochloride | 90 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 90 | | 5 |
| 63629-8206-3 | Cyclobenzaprine Hydrochloride | 60 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 60 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-8206 | CYCLOBENZAPRINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK] | 5 | Current NDC, Legacy NDC, 3 package rows | 20250328_2169667d-4f4b-472d-929b-8a0bcbddbe9c.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 |
|---|
| 63629-8206-1 | 63629820601 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-8206-1) | 2024-07-08 | 0000-00-00 | No | No | Current |
| 63629-8206-2 | 63629820602 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-8206-2) | 2024-07-08 | 0000-00-00 | No | No | Current |
| 63629-8206-3 | 63629820603 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-8206-3) | 2024-07-08 | | No | No | Historical |