Cyclobenzaprine Hydrochloride
- Product NDC
- 16571-782
- 11-digit product format
- 165710782
- Labeler code
- 16571
- Product ID
- 16571-782_0280b504-4a42-44f3-8a1a-34a20eac054a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA078643
- Marketing category
- ANDA
- Marketing start
- 2008-09-26
- 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 |
|---|---|
| CYCLOBENZAPRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 0VE05JYS2P |
| Rxcui | 828320, 828348 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 51048710-225c-aa41-d0e7-eed095d02838 | Product name | 4 | 20250331 |
| c2c26dc9-7e16-fc02-7eba-6b46ed3515ee | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 16571-782-01 | Cyclobenzaprine Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 1 | |
| 16571-782-10 | Cyclobenzaprine Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | 1 | |
| 16571-782-50 | Cyclobenzaprine Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 16571-782-01 | EA - Each | 16571-782 | 5c160f3c-a3f7-4f5d-926a-9f4fd5e4eef2 | 1 | 2021-11-09 |
| 16571-782-10 | EA - Each | 16571-782 | f8395a2d-ca38-4458-a2eb-0e1f593f2a56 | 1 | 2021-11-09 |
| 16571-782-50 | EA - Each | 16571-782 | 325f1855-f2a5-450f-903e-765d09959374 | 1 | 2021-11-09 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 828320 | cyclobenzaprine HCl 5 MG Oral Tablet | PSN | 0a695685-cfec-464e-840c-32e3b7a68bd3 | 105 |
| 828320 | cyclobenzaprine hydrochloride 5 MG Oral Tablet | SCD | 0a695685-cfec-464e-840c-32e3b7a68bd3 | 105 |
| 828320 | cyclobenzaprine HCl 5 MG Oral Tablet | PSN | 29ca9548-23b0-4c50-82cb-4f0564d7e065 | 5 |
| 828320 | cyclobenzaprine hydrochloride 5 MG Oral Tablet | SCD | 29ca9548-23b0-4c50-82cb-4f0564d7e065 | 5 |
| 828320 | cyclobenzaprine HCl 5 MG Oral Tablet | PSN | e3b5fc92-9186-6944-e053-2a95a90a1c9f | 4 |
| 828320 | cyclobenzaprine hydrochloride 5 MG Oral Tablet | SCD | e3b5fc92-9186-6944-e053-2a95a90a1c9f | 4 |
| 828348 | cyclobenzaprine HCl 10 MG Oral Tablet | PSN | 508e310e-067a-4f95-869a-e1da49aabe94 | 3 |
| 828320 | cyclobenzaprine HCl 5 MG Oral Tablet | PSN | fbe6ba88-0581-50ef-e053-6394a90ab086 | 3 |
| 828320 | cyclobenzaprine HCl 5 MG Oral Tablet | PSN | 508e310e-067a-4f95-869a-e1da49aabe94 | 3 |
| 828348 | cyclobenzaprine hydrochloride 10 MG Oral Tablet | SCD | 508e310e-067a-4f95-869a-e1da49aabe94 | 3 |
| 828320 | cyclobenzaprine hydrochloride 5 MG Oral Tablet | SCD | 508e310e-067a-4f95-869a-e1da49aabe94 | 3 |
| 828320 | cyclobenzaprine hydrochloride 5 MG Oral Tablet | SCD | fbe6ba88-0581-50ef-e053-6394a90ab086 | 3 |
| 828320 | cyclobenzaprine HCl 5 MG Oral Tablet | PSN | 1912d134-a909-5511-e063-6294a90aea29 | 2 |
| 828320 | cyclobenzaprine hydrochloride 5 MG Oral Tablet | SCD | 1912d134-a909-5511-e063-6294a90aea29 | 2 |
| 828348 | cyclobenzaprine HCl 10 MG Oral Tablet | PSN | 0280b504-4a42-44f3-8a1a-34a20eac054a | 1 |
| 828320 | cyclobenzaprine HCl 5 MG Oral Tablet | PSN | 0280b504-4a42-44f3-8a1a-34a20eac054a | 1 |
| 828320 | cyclobenzaprine HCl 5 MG Oral Tablet | PSN | 32da07a1-2b0c-44bb-a3b4-31ba8274d226 | 1 |
| 828320 | cyclobenzaprine HCl 5 MG Oral Tablet | PSN | e3998083-e3db-4052-9b5b-19d7aaa4e658 | 1 |
| 828348 | cyclobenzaprine hydrochloride 10 MG Oral Tablet | SCD | 0280b504-4a42-44f3-8a1a-34a20eac054a | 1 |
| 828320 | cyclobenzaprine hydrochloride 5 MG Oral Tablet | SCD | e3998083-e3db-4052-9b5b-19d7aaa4e658 | 1 |
| 828320 | cyclobenzaprine hydrochloride 5 MG Oral Tablet | SCD | 32da07a1-2b0c-44bb-a3b4-31ba8274d226 | 1 |
| 828320 | cyclobenzaprine hydrochloride 5 MG Oral Tablet | SCD | 0280b504-4a42-44f3-8a1a-34a20eac054a | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 16571-782-01 | 16571078201 | 100 TABLET, FILM COATED in 1 BOTTLE (16571-782-01) | 2008-09-26 | 0000-00-00 | No | No | Current |
| 16571-782-10 | 16571078210 | 1000 TABLET, FILM COATED in 1 BOTTLE (16571-782-10) | 2008-09-26 | 0000-00-00 | No | No | Current |
| 16571-782-50 | 16571078250 | 500 TABLET, FILM COATED in 1 BOTTLE (16571-782-50) | 2008-09-26 | 0000-00-00 | No | No | Current |