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 |
|---|---|---|---|---|---|---|
| Constipation | ECHINACEA, IRIS VERSICOLOR, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ABIES NIGRA, AESCULUS HIPPOCASTANUM, ALOE, ALUMINA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLLINSONIA CANADENSIS, GRAPHITE, HYDRASTIS CANADENSIS 15X, KALI CARBONICUM 15X, LYCOPODIUM CLAVATUM 15X, MAGNESIA MURIATICA 15X, MEZEREUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHAMNUS PURSHIANA, SANICULA, SELENIUM METALLICUM, SEPIA, SILICEA, TABACUM, VERATRUM ALBUM, ZINCUM METALLICUM | Newton Laboratories, Inc. | 9d63b107-cd47-d9a5-e053-2a95a90a4493 | 2025-01-28 | Warnings | ETJ7Z6XBU4 |
| TiZO Mineral Sun Defense SPF 50 | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals Ltd. | 2cc8f7ef-eda3-fe71-e063-6394a90a6a9a | 2025-01-28 | Warnings | 15FIX9V2JP |
| Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30 | TITANIUM DIOXIDE AND ZINC OXIDE | Z&Z Skin Essentials | 2cdc48f3-474f-9c06-e063-6294a90afea1 | 2025-01-27 | Warnings | 15FIX9V2JP |
| Cetaphil Sheer Mineral Sunscreen Stick SPF 50 | TITANIUM DIOXIDE, ZINC OXIDE | Galderma Laboratories, L.P. | 54f6df65-e90c-4070-aa95-f47496dd11bd | 2025-01-27 | Warnings | 15FIX9V2JP |
| Bestmade Natural Products BM55 | DAPHNE INDICA, NATRUM PHOS, SILICA MARINA, TABACUM | Bestmade Natural Products | 2c751942-5b36-8558-e063-6294a90af87a | 2025-01-24 | Warnings | ETJ7Z6XBU4 |
| Constipation | ECHINACEA, IRIS VERSICOLOR, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ABIES NIGRA, AESCULUS HIPPOCASTANUM, ALOE, ALUMINA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLLINSONIA CANADENSIS, GRAPHITE, HYDRASTIS CANADENSIS 15X, KALI CARBONICUM 15X, LYCOPODIUM CLAVATUM 15X, MAGNESIA MURIATICA 15X, MEZEREUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHAMNUS PURSHIANA, SANICULA, SELENIUM METALLICUM, SEPIA, SILICEA, TABACUM, VERATRUM ALBUM, ZINCUM METALLICUM | Newton Laboratories, Inc. | 9d626292-7abb-1afb-e053-2995a90a2818 | 2025-01-24 | Warnings | ETJ7Z6XBU4 |
| CoTZ Silky Foam - Tinted | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals, LTD | d63088d7-a1d7-4b56-a7d8-ad217011a8a8 | 2025-01-24 | Warnings | 15FIX9V2JP |
| CoTZ Silky Foam Non-Tinted | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals, LTD | 9c04b76e-ae65-4183-b475-3b8e8764db59 | 2025-01-24 | Warnings | 15FIX9V2JP |
| Cyclobenzaprine hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Redpharm Drug, Inc. | 09d0e2fc-76a4-bb7d-e063-6394a90a4a7d | 2025-01-23 | Warnings, Adverse reactions | 828348 0VE05JYS2P |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Redpharm Drug | fc61c9f5-b0ec-3ff8-e053-6394a90adeb7 | 2025-01-23 | Warnings, Adverse reactions | 828348 0VE05JYS2P |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Redpharm Drug | 09d35c34-11fa-3a5d-e063-6294a90ab172 | 2025-01-23 | Warnings, Adverse reactions | 828348 0VE05JYS2P |
| DOCTRUST K Tooth | SILICON DIOXIDE, SODIUM MONOFLUOROPHOSPHATE | DOCSMEDI Co., Ltd. | a02f8865-e7be-4ef4-b09c-dad846639764 | 2025-01-22 | Warnings | ETJ7Z6XBU4 |
| Cyclobenzaprine HCL ER | CYCLOBENZAPRINE HCL ER | Direct_Rx | e4a3383a-7b30-25b7-e053-2995a90a341b | 2025-01-22 | Warnings, Adverse reactions | 0VE05JYS2P |
| Cyclobenzaprine HCL ER | CYCLOBENZAPRINE HCL ER | Direct_Rx | ed0b9acc-132f-64c0-e053-2995a90a198c | 2025-01-22 | Warnings, Adverse reactions | 0VE05JYS2P |
| Lemon Quince | LEMON QUINCE | Uriel Pharmacy Inc | 332e4a40-e0f3-11de-8a39-0800200c9a66 | 2025-01-22 | Warnings | ETJ7Z6XBU4 |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | DirectRx | ceb56ab8-4a76-6dee-e053-2995a90aab30 | 2025-01-20 | Warnings, Adverse reactions | ANDA208170 828320 0VE05JYS2P |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | DIRECT RX | a58cf759-048b-6740-e053-2a95a90a8b43 | 2025-01-17 | Warnings, Adverse reactions | ANDA208170 828348 0VE05JYS2P |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | DIRECT RX | a512d34c-8164-0c04-e053-2995a90a1942 | 2025-01-17 | Warnings, Adverse reactions | 0VE05JYS2P |
| Proceuticals Private Label by TiZO Tinted Facial Mineral Sunscreen Backbar | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals, LTD | 2be9f92a-a041-0595-e063-6394a90af7a8 | 2025-01-17 | Warnings | 15FIX9V2JP |
| Hydration Complex | BETA VULGARIS, BOLDO, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CARDUUS BENEDICTUS, CHELIDONIUM MAJUS, COFFEA TOSTA, EQUISETUM ARVENSE, GERMANIUM SESQUIOXIDE, GINKGO BILOBA, HYPERICUM PERFORATUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, PETROSELINUM SATIVUM, SILICEA, TARAXACUM OFFICINALE | Deseret Biologicals, Inc. | f60a2ab8-4146-4995-9bc6-be2660b17540 | 2025-01-16 | Warnings | ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.