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 |
|---|---|---|---|---|---|---|
| Respiforce A-HP | ARSENICUM ALBUM, BELLADONNA, IPECACUANHA, KALI CARBONICUM, LOBELIA INFLATA, NATRUM SULPHURICUM, SILICEA | BioActive Nutritional, Inc. | ebf5f0c7-e7a4-45fe-acfd-52c46a8d789c | 2026-03-05 | Warnings | ETJ7Z6XBU4 |
| Sinus Defense 2.0 | LAC VACCINUM, SILICEA, ASPERGILLUS NIGER, BABESIA MICROTI, BORRELIA BURGDORFERI, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, CHLAMYDIA TRACHOMATIS, COLIBACILLINUM CUM NATRUM MURIATICUM, CYTOMEGALOVIRUS NOSODE, EHRLICHIA NOSODE, HERPES SIMPLEX I AND II NOSODE, HUMAN PAPILLOMA NOSODE, KLEBSIELLA PNEUMONIAE, MUCOR RACEMOSUS, MYCOBACTERIUM PARATUBERCULOSIS, PNEUMOCCOCCINUM, STAPHYLOCOCCUS AUREUS, STREPTOCOCCUS VIRIDANS, EPSTEIN-BARR VIRUS NOSODE, HERPES ZOSTER NOSODE | Micro Balance Health Products LLC | 560f84f6-2544-4ba8-8236-a95906eb7d97 | 2026-03-04 | Warnings | ETJ7Z6XBU4 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 4c3a3b4f-7b2b-3fe9-e063-6394a90aae47 | 2026-03-04 | Warnings, Adverse reactions | ANDA208170 828348 0VE05JYS2P |
| Snore Control | BROMIUM, CHAMOMILLA, CINCHONA, CUPRUM METALLICUM, HELLEBORUS NIGER, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, LAUROCERASUS, NUX VOMICA, PHOSPHORICUM ACIDUM, RHUS TOX, SILICEA, STRAMONIUM, SULPHUR AND ZINCUM METALLICUM. | King Bio Inc. | 704bb574-6c54-49d1-bdae-81ffe0e79d10 | 2026-03-04 | Warnings | ETJ7Z6XBU4 |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | Bryant Ranch Prepack | dc3cc6b6-c692-4986-8ff7-3a6cd8c85cb2 | 2026-03-04 | Warnings, Adverse reactions | ANDA208170 828348 0VE05JYS2P |
| Refresh Optive Mega-3 PF | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80 | Allergan, Inc. | 326cb5d6-c784-404f-9a13-6d69262dda6e | 2026-03-01 | Warnings | 6OZP39ZG8H |
| 911 Adrenal Burnout and Fatigue | ACETICUM AC, ADRENALINUM, ADRENOCORTICOTROPHIN (30X), AESCULUS HIPPOCASTANUM, FLOS, ALFALFA, ALPHA-LIPOIC AC, AMBRA, ARG NIT, AVENA SATIVA, BRYONIA, CARBONEUM OXYGENISATUM, CARPINUS BETULUS, FLOS, DNA, FUMARICUM ACIDUM, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, HYPOTHALAMUS, KALI PHOSPHORICUM, LACTICUM ACIDUM, LECITHIN, NATRUM MURIATICUM, OXALICUM ACIDUM, PHOSPHORICUM ACIDUM, PITUITARUM POSTERIUM, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SEPIA, SILICEA, SUCCINICUM ACIDUM AND THYROIDINUM. | King Bio Inc. | 21c6b6c1-e846-4f25-a1dc-02e79d1be756 | 2026-02-26 | Warnings | ETJ7Z6XBU4 |
| TIBENA EVERY DAY REAL SUN BLOCK | TITANIUM DIOXIDE, ZINC OXIDE | KONAD CO LTD | 211c9930-4f91-cf8f-e063-6394a90a97b3 | 2026-02-26 | Warnings | 15FIX9V2JP |
| CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION MATTE M B10 | TITANIUM DIOXIDE | Shiseido Americas Corporation | 54f8210f-4934-4ada-89c3-aa89e7a09260 | 2026-02-26 | Warnings | 15FIX9V2JP |
| Resilience | CEREBRUM SUIS, HYPOTHALAMUS SUIS, HYPOPHYSIS SUIS, SEROTONIN (HYDROCHLORIDE), NPY (NEUROPEPTIDE Y), CALCAREA CARBONICA, SILICEA, VERATRUM ALBUM, BLATTA AMERICANA, CACAO, DIOSPYROS KAKI, FORMICA RUFA, PALOONDO, SULPHUR, TAXUS BACCATA, TELA ARANEAE, SALIX VITELLINA, FLOS | Deseret Biologicals, Inc. | 3aa6c1e7-2bd9-4c2d-bfd4-63ffb7c62e9c | 2026-02-26 | Warnings | ETJ7Z6XBU4 |
| Quantum Harmony | BLATTA AMERICANA, CEREBRUM SUIS, CACAO, COLUMBUS PALUMBA, HEART (SUIS), DIOSPYROS KAKI, FORMICA RUFA, HYPOTHALAMUS SUIS, HYPOPHYSIS SUIS, PALOONDO, NPY (NEUROPEPTIDE Y), SEROTONIN (HYDROCHLORIDE), SILICEA, SULPHUR, VERATRUM ALBUM, SALIX VITELLINA, FLOS | Deseret Biologicals, Inc. | 1742ac50-ec6e-4261-a0b8-791b893742ef | 2026-02-25 | Warnings | ETJ7Z6XBU4 |
| SHISEIDO UV PROTECTIVE COMPACT (REFILL) FAIR IVORY | OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | c05cef12-a6a7-4682-9357-6d77f4ca3267 | 2026-02-25 | Warnings | 15FIX9V2JP |
| cle de peau BEAUTE RADIANT FOUNDATION N M I10 | OCTINOXATE AND TITANIUM DIOXIDE | Shiseido Americas Corporation | 3be1fe06-bd3b-4078-bee9-d3caf8d068ff | 2026-02-25 | Warnings | 15FIX9V2JP |
| cle de peau BEAUTE THE FOUNDATION N M O20 | OCTINOXATE AND TITANIUM DIOXIDE | Shiseido Americas Corporation | 9507f6d1-c11c-428d-8d95-b436f27ba26a | 2026-02-24 | Warnings | 15FIX9V2JP |
| Perfect Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | SKIN PERFECT MEDICAL | 4b93538a-3b3e-90f7-e063-6294a90ab898 | 2026-02-24 | Warnings | 15FIX9V2JP |
| ANTI-AGING TINTED SUNSCREEN | TITANIUM DIOXIDE, ZINC OXIDE | LASER GIRL SKINCARE, LLC | 4b93cd22-1289-29bc-e063-6294a90ab781 | 2026-02-24 | Warnings | 15FIX9V2JP |
| ANTI-AGING TINTED SUNSCREEN | TITANIUM DIOXIDE, ZINC OXIDE | LASER GIRL SKINCARE, LLC | 4b943d72-dcde-e2e4-e063-6294a90ab7c4 | 2026-02-24 | Warnings | 15FIX9V2JP |
| ANTI-AGING NON-TINTED SUNSCREEN | TITANIUM DIOXIDE, ZINC OXIDE | LASER GIRL SKINCARE, LLC | 4b946c39-718b-d70e-e063-6394a90a0db8 | 2026-02-24 | Warnings | 15FIX9V2JP |
| Outdoor Allergies | ACONITUM NAPELLUS, ADRENALINUM, ALLIUM CEPA, RAGWEED POLLEN, ARSENICUM IODATUM, MUGWORT POLLEN, MUSTARD POLLEN, LAMBS QUARTERS POLLEN, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, PERENNIAL RYE GRASS POLLEN, ALFALFA POLLEN, TIMOTHY GRASS POLLEN, YELLOW DOCK POLLEN, SABADILLA, SILICEA, DANDELION POLLEN, RED CLOVER POLLEN, COCKLEBUR POLLEN | NaturalCare | b0a76faa-a081-4cee-ae40-e5605458bec3 | 2026-02-23 | Warnings | ETJ7Z6XBU4 |
| BM BIO28 (General Tonic) | CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA | BM Private Limited | 38d2cff0-3550-b119-e063-6394a90a31cb | 2026-02-23 | Warnings | ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.