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 |
|---|---|---|---|---|---|---|
| Cyclobenzaprine hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 348c7ad4-b380-4b78-88f4-106b94079f52 | 2026-04-01 | Warnings, Adverse reactions | 828348 0VE05JYS2P |
| Clinical Skin Filter Tinted Sunscreen | CLINICAL SKIN FILTER TINTED SUNSCREEN | BY KIN AESTHETICS LLC | 4e69a8a3-8dbb-577a-e063-6294a90a6a23 | 2026-04-01 | Warnings | 15FIX9V2JP |
| Krx Aesthetics All Day Glow Sunblocker | KRX AESTHETICS ALL DAY GLOW SUNBLOCKER | BY KIN AESTHETICS LLC | 4e69df43-393b-bc09-e063-6394a90a275a | 2026-04-01 | Warnings | 15FIX9V2JP |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | e4e8bab3-c5e7-4d2b-9692-ee6c6799b120 | 2026-04-01 | Warnings, Adverse reactions | ANDA208170 828320 0VE05JYS2P |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 014dd648-5b84-4d1d-80fc-a467e2d741ef | 2026-04-01 | Warnings, Adverse reactions | 828348 0VE05JYS2P |
| Cyclobenzaprine hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ac8ae965-af50-41d3-8df5-ca6daf4bbd1c | 2026-04-01 | Warnings, Adverse reactions | 828320 0VE05JYS2P |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | e343fd12-1ca2-418a-b690-f3e8f567596d | 2026-04-01 | Warnings, Adverse reactions | ANDA208170 828348 0VE05JYS2P |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 29ca9548-23b0-4c50-82cb-4f0564d7e065 | 2026-04-01 | Warnings, Adverse reactions | 828320 0VE05JYS2P |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | a4cc7965-2ba8-42e8-8c5c-b90145a6598a | 2026-04-01 | Warnings, Adverse reactions | 828299 0VE05JYS2P |
| spf 50 mineral powder sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Smalls Brand LLC DBA Roe Wellness | f8762dd1-0484-74ea-e053-6294a90ac112 | 2026-03-31 | Warnings | 15FIX9V2JP |
| SeranovaTM ULTRALIGHT SPF50 SERUM | SERANOVATM ULTRALIGHT SPF50 SERUM | Guangzhou Ariel Biotech Co., Ltd. | 4e5d716d-2b2d-d42f-e063-6294a90a1e52 | 2026-03-31 | Warnings | 15FIX9V2JP |
| Acne HP | CARBO ANIMALIS, CARBO VEGETABILIS, KALI BICHROMICUM, NATRUM MURIATICUM, PULSATILLA (VULGARIS), SEPIA, SILICEA, SULPHUR, ZINCUM METALLICUM | BioActive Nutritional, Inc. | 2ab4ff53-4274-40c7-b05c-44d918d809be | 2026-03-31 | Warnings | ETJ7Z6XBU4 |
| Lymphoplex | MYRRHA, TRIGONELLA FOENUM-GRAECUM, PINUS SYLVESTRIS, LYMPH (SUIS), SPLEEN (SUIS), CONIUM MACULATUM, ECHINACEA (ANGUSTIFOLIA), HEPAR SULPHURIS CALCAREUM, HYDRANGEA ARBORESCENS, PHYTOLACCA DECANDRA, SILICEA | BioActive Nutritional, Inc. | 624f35db-291e-4e7f-a2c9-ae319717157a | 2026-03-30 | Warnings | ETJ7Z6XBU4 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | REMEDYREPACK INC. | fada6577-bcb8-422c-be37-08562919ebc9 | 2026-03-30 | Warnings, Adverse reactions | 0VE05JYS2P |
| Equisetum Silicea | EQUISETUM SILICEA | Uriel Pharmacy Inc. | e88b820b-4a07-42e2-8fe2-b30729e91a8c | 2026-03-30 | Warnings | ETJ7Z6XBU4 |
| B Force HP | APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, LACHESIS MUTUS, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEA | BioActive Nutritional, Inc. | 811c6f32-fcad-464c-bcf6-ae6a59195b1c | 2026-03-30 | Warnings | ETJ7Z6XBU4 |
| Lymphdrainex | GERANIUM ROBERTIANUM, NASTURTIUM AQUATICUM, TEUCRIUM SCORODONIA, EQUISETUM HYEMALE, FUMARIA OFFICINALIS, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, PINUS SYLVESTRIS, VERONICA OFFICINALIS, BAPTISIA TINCTORIA, GALIUM APARINE, GENTIANA LUTEA, APIS MELLIFICA, SARSAPARILLA (SMILAX REGELII), BARYTA CARBONICA, HEPAR SULPHURIS CALCAREUM, MERCURIUS CYANATUS, SCROPHULARIA NODOSA, ALOE, FERRUM IODATUM, MYOSOTIS ARVENSIS, ARANEA DIADEMA, CALCAREA PHOSPHORICA, JUGLANS REGIA, PARATHYROID GLAND (BOVINE), SILICEA, | Energique, Inc. | c512f211-f4f8-46f6-87ed-dd50287359df | 2026-03-27 | Warnings | ETJ7Z6XBU4 |
| UV SOLUTIONS BRIGHTENING TINTED BROAD SPECTRUM SPF 50 SUNSCREEN NIACINAMIDE ANTIOXIDANTS DARK SHADE | TITANIUM DIOXIDE AND ZINC OXIDE | CLINIQUE LABORATORIES LLC | 4e0bd355-99c6-8cf4-e063-6294a90ab4b3 | 2026-03-27 | Warnings | 15FIX9V2JP |
| Crocodile Tears Lubricant Eye Drops | GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400 | Crocodile Tears LLC | 4df29336-ea0c-0484-e063-6294a90a685a | 2026-03-26 | Warnings | B697894SGQ 3NXW29V3WO |
| SUNNYSIDEKICK UVA/UVB Broad Spectrum SPF 30 Brush-On Mineral | ZINC OXIDE, TITANIUM DIOXIDE | Classic Cosmetics LLC | 4df3b8c0-71bc-acdd-e063-6394a90a35c0 | 2026-03-26 | Warnings | 15FIX9V2JP |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.