NDC 68071-3475-01 - CYCLOBENZAPRINE HYDROCHLORIDE
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 68071-3475
- Requested NDC
- 68071-3475-01
- Package NDCs from labels
- 68071-3475-2, 68071-3475-3, 68071-3475-1, 68071-3475-4, 68071-3475-9, 68071-3475-01
- Manufacturer
- NuCare Pharmaceuticals,Inc.
- Effective date
- 2025-01-14
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Cyclobenzaprine hydrochloride, USP | NuCare Pharmaceuticals,Inc. | 2025-01-14 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-3475-1 | CYCLOBENZAPRINE HYDROCHLORIDE | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | 5 | |
| 68071-3475-2 | CYCLOBENZAPRINE HYDROCHLORIDE | 12 in 1 BOTTLE | TABLET, FILM COATED | 12 | 5 | |
| 68071-3475-3 | CYCLOBENZAPRINE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 5 | |
| 68071-3475-4 | CYCLOBENZAPRINE HYDROCHLORIDE | 14 in 1 BOTTLE | TABLET, FILM COATED | 14 | 5 | |
| 68071-3475-9 | CYCLOBENZAPRINE HYDROCHLORIDE | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-3475 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] | 5 | Current NDC, 5 package rows | 20250116_01e18825-1cf9-a98c-e063-6294a90ae0a4.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Parathyropar | SYMPHYTUM OFFICINALE, BARYTA CARBONICA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, HEKLA LAVA, MANGANUM METALLICUM, PARATHYROID GLAND (BOVINE), RHUS TOX, SILICEA | Energique, Inc. | 6b098910-2f36-4757-a463-e01105340c43 | 2026-01-05 | Warnings | ETJ7Z6XBU4 |
| VACC HC | ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, BRYONIA (ALBA), ECHINACEA (ANGUSTIFOLIA), GELSEMIUM SEMPERVIRENS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYOSCYAMUS NIGER, INFLUENZINUM, LEDUM PALUSTRE, MERCURIUS SOLUBILIS, MEZEREUM, NICOTINAMIDUM, HUMAN CORONAVIRUS (RNA), SENEGA OFFICINALIS, SILICEA, SPIGELIA ANTHELMIA, SULPHUR, THUJA OCCIDENTALIS, ZINCUM METALLICUM | Deseret Biologicals, Inc. | 16d782b2-1bef-45e5-8a1d-721b1ffe5631 | 2026-01-05 | Warnings | ETJ7Z6XBU4 |
| Bellas Friends Roll-on Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | PANERGYTEK USA INC | 478d46ce-14e8-2231-e063-6394a90a3e27 | 2026-01-04 | Warnings | 15FIX9V2JP |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | NORTHSTAR RX LLC | 2a3a13c3-116c-4e9e-a7f3-7ad7c80486c3 | 2026-01-02 | Warnings, Adverse reactions | ANDA208170 828299 828320 828348 0VE05JYS2P |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | Northwind Health Company, LLC | c29cf8bd-2f63-ed4b-e053-2995a90ab6eb | 2026-01-01 | Warnings, Adverse reactions | ANDA208170 828320 0VE05JYS2P |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | Northwind Health Company, LLC | dae3be94-a40c-5be1-e053-2a95a90a1484 | 2026-01-01 | Warnings, Adverse reactions | ANDA208170 828348 0VE05JYS2P |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE | Northwind Health Company, LLC | e04eea45-12ec-4d2b-e053-2a95a90a6b76 | 2026-01-01 | Warnings, Adverse reactions | 828348 0VE05JYS2P |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | Northwind Health Company, LLC | f32bceda-1d24-322d-e053-2995a90aae1b | 2026-01-01 | Warnings, Adverse reactions | ANDA208170 828348 0VE05JYS2P |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | Northwind Health Company, LLC | f708cf0f-8373-14a2-e053-6394a90ab3fe | 2026-01-01 | Warnings, Adverse reactions | ANDA208170 828320 0VE05JYS2P |
| Youth Glow Vitamin C CC Cream Sunscreen SPF 50 - Fair | OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE | Pur-lisse Beauty, LLC | 47428cd4-fbad-ba7a-e063-6394a90a1c5c | 2025-12-31 | Warnings | 15FIX9V2JP |
| Youth Glow Vitamin C CC Cream Sunscreen SPF 50 - Medium | OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE | Pur-lisse Beauty, LLC | 47433a62-91e0-b031-e063-6294a90a0d49 | 2025-12-31 | Warnings | 15FIX9V2JP |
| Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Fair | OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE | Pur-lisse Beauty, LLC | 4743b6a9-4d79-1b2b-e063-6394a90a9710 | 2025-12-31 | Warnings | 15FIX9V2JP |
| Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Light Medium | OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE | Pur-lisse Beauty, LLC | 4744e501-f12a-6d25-e063-6394a90a2574 | 2025-12-31 | Warnings | 15FIX9V2JP |
| Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Medium | OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE | Pur-lisse Beauty, LLC | 47456bf5-9f6c-e6a5-e063-6294a90a7054 | 2025-12-31 | Warnings | 15FIX9V2JP |
| Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Tan | OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE | Pur-lisse Beauty, LLC | 4745ab56-abaa-42de-e063-6394a90a6310 | 2025-12-31 | Warnings | 15FIX9V2JP |
| Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Tan Deep | OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE | Pur-lisse Beauty, LLC | 4745ebec-acb0-77c4-e063-6394a90aee07 | 2025-12-31 | Warnings | 15FIX9V2JP |
| Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Deep | OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE | Pur-lisse Beauty, LLC | 47461ad3-a11e-2a11-e063-6294a90a0f8f | 2025-12-31 | Warnings | 15FIX9V2JP |
| Sei Bella CC Brightening Creme Light | OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1% | Melaleuca Inc. | 6894b9d9-a5b5-4c98-e053-2991aa0a9ca2 | 2025-12-31 | Warnings | 15FIX9V2JP |
| Sei Bella CC Brightening Creme Fair | OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1% | Melaleuca Inc. | 6892952a-d032-30bf-e053-2a91aa0a3bba | 2025-12-31 | Warnings | 15FIX9V2JP |
| Sei Bella CC Brightening Creme Medium Tan | OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1% | Melaleuca Inc. | 68a4e8b4-36cb-6306-e053-2a91aa0a6d25 | 2025-12-31 | Warnings | 15FIX9V2JP |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.