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 |
|---|---|---|---|---|---|---|
| Sei Bella Tinted BB Moisturizing Cream | 410 N | Melaleuca Inc. | 2f380433-3369-9d05-e063-6394a90a6479 | 2026-03-17 | Warnings | 15FIX9V2JP |
| Sei Bella Tinted BB Moisturizing Cream | 115 N | Melaleuca Inc. | 2f132cc0-e8e3-35e3-e063-6394a90a4f3d | 2026-03-17 | Warnings | 15FIX9V2JP |
| Tinted Sunscreen Broad SPF30 | TINTED SUNSCREEN BROAD SPF30 | DOSCHER FAMILY HEALTH NP P.C. | 4d4021ba-4b29-6b81-e063-6294a90a5ea7 | 2026-03-17 | Warnings | 15FIX9V2JP |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 96b650d8-4ad5-42af-aa8c-aa0ac25abfb5 | 2026-03-17 | Warnings, Adverse reactions | 0VE05JYS2P |
| BM BIO18 | CALC FLUOR, CALC SULF, SILICEA. | BM Private Limited | 4d269a3b-18ba-3ad2-e063-6294a90a1fae | 2026-03-16 | Warnings | ETJ7Z6XBU4 |
| HYDRATING TINTED MOISTURIZER SPF50 | HYDRATING TINTED MOISTURIZER SPF50 | NING PTE. LTD. | 4cf8d3d3-eebf-2da0-e063-6294a90a7065 | 2026-03-14 | Warnings | 15FIX9V2JP |
| TINTED WATERY SUNSCREEN | TITANIUM DIOXIDE, ZINC OXIDE | KSISTERS PTE. LTD. | 4ced53d0-8bfc-ff8e-e063-6294a90a9dbd | 2026-03-13 | Warnings | 15FIX9V2JP |
| Daily Moisturizing Mineral Sunscreen | BROAD SPECTRUM SPF30 | EDINA PLASTIC SURGERY,LTD. | 4d056e2b-5813-da42-e063-6294a90ac519 | 2026-03-13 | Warnings | 15FIX9V2JP |
| Ligatone | ARNICA MONTANA, BRYONIA, CALCAREA PHOSPHORICA, CAUSTICUM, KALI CARBONICUM, MANGANESE GLUCONATE, MEZEREUM, RHUS TOX, RUTA GRAVEOLENS, SILICEA | BioActive Nutritional, Inc. | 3a3bdd55-daec-43b9-a380-54a747fb7d10 | 2026-03-13 | Warnings | ETJ7Z6XBU4 |
| Leader Ultra Lubricating Eye Drops | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL | Cardinal Health | d7f011a2-05ba-47c3-9519-d31602e105c7 | 2026-03-12 | Warnings | B697894SGQ |
| Leader Advanced Relief Eye Drops | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL | Cardinal Health | 5c5d6c13-9b51-48f0-8627-b60b0f707fd3 | 2026-03-12 | Warnings | B697894SGQ |
| Neutrogena Healthy Skin Liquid Makeup Broad Spectrum SPF 20 - Cool Bronze 440C | TITANIUM DIOXIDE | Kenvue Brands LLC | 4c335d9c-40ca-c0ce-e063-6394a90ac20a | 2026-03-11 | Warnings | 15FIX9V2JP |
| Lower GI and Probiotic Restoration | AETHUSA CYNAPIUM, ALLIUM SATIVUM, BAPTISIA TINCTORIA, CAPSICUM ANNUUM, CARBO VEGETABILIS, CHAMOMILLA, CINCHONA OFFICINALIS, COLLINSONIA CANADENSIS, COLOCYNTHIS, CONDURANGO, GAMBOGIA, GRATIOLA OFFICINALIS, LAC VACCINUM, LACTICUM ACIDUM, NATRUM CARBONICUM, NUX VOMICA, PODOPHYLLUM PELTATUM, SEPIA AND SILICEA. | King Bio Inc. | 2e1f3ca1-9036-4f14-bd3c-d0eed9a9ff93 | 2026-03-10 | Warnings | ETJ7Z6XBU4 |
| Constitutional Enhancer | ACONITUM NAPELLUS, ARSENICUM ALBUM, BARYTA CARBONICA, BRYONIA, CALCAREA CARBONICA, CANTHARIS, GELSEMIUM SEMPERVIRENS, GRAPHITES, HYDRASTIS CANADENSIS, KALI IODATUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHUS TOX, SEPIA, SILICEA AND SULPHUR. | King Bio Inc. | 448becd7-58aa-40ae-9b4b-39f48a8f13dd | 2026-03-10 | Warnings | ETJ7Z6XBU4 |
| Vermiclear | GRANATUM, RHAMNUS PURSHIANA, JUGLANS REGIA, FILIX MAS, ABSINTHIUM, AESCULUS HIPPOCASTANUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, CINA, CINCHONA OFFICINALIS, CUPRUM METALLICUM, IPECACUANHA, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, NUX VOMICA, PODOPHYLLUM PELTATUM, PULSATILLA (VULGARIS), RATANHIA, RHUS TOX, SABADILLA, SILICEA, SPIGELIA ANTHELMIA, TEREBINTHINA, TEUCRIUM MARUM | Energique, Inc. | f7cf3edd-2451-4a4f-b1f2-1b3db2bb4dca | 2026-03-09 | Warnings | ETJ7Z6XBU4 |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | DirectRx | cdc5b438-6b6b-0cdd-e053-2a95a90a7f75 | 2026-03-06 | Warnings, Adverse reactions | 828320 0VE05JYS2P |
| Artificial Tears | GLYCERIN | Preferred Pharmaceuticals Inc. | dd646c72-8f47-43c6-a734-db0dcc8cd4d1 | 2026-03-06 | Warnings | B697894SGQ 3NXW29V3WO |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Direct_Rx | 15aad4af-5c05-be36-e063-6294a90a9bb3 | 2026-03-05 | Warnings, Adverse reactions | ANDA208170 828348 0VE05JYS2P |
| cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL B50 | OCTINOXATE AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | 4490f968-46b6-44d2-af2d-5130b52c8861 | 2026-03-05 | Warnings | 15FIX9V2JP |
| Osteoplex | EQUISETUM HYEMALE, MAGNESIA MURIATICA, ASCORBICUM ACIDUM, MANGANUM MURIATICUM, SYMPHYTUM OFFICINALE, MEDULLA OSSIS SUIS, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEA, PARATHYROID GLAND (SUIS), LIGAMENT (SUIS) | BioActive Nutritional, Inc. | 8a7e1397-a387-4f2c-ab4f-7f1a7f1a849b | 2026-03-05 | Warnings | ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.