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 |
|---|---|---|---|---|---|---|
| Aging Eye Formula | CINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUM | Nutritional Specialties, Inc. | d5b44f79-5299-4b31-ba45-0e511cdbe17c | 2026-08-24 | Warnings | ETJ7Z6XBU4 |
| Rohto All-In-One | HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE | The Mentholatum Company | 43e690e4-b381-46e3-838c-33aef5bdadde | 2026-08-20 | Warnings | 3NXW29V3WO |
| Rohto Max Strength | NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80 | The Mentholatum Company | e4b49550-1ca3-4bd7-854d-409b53fa5e26 | 2026-08-20 | Warnings | 6OZP39ZG8H |
| Bio Combination 28 | SCHUESSLER SALTS | LDD Bioscience Private Limited | 597caf33-5107-9dec-e063-6294a90a5fcd | 2026-08-20 | Warnings | ETJ7Z6XBU4 |
| Sweat Resistant Sunscreen Body Original | TITANIUM DIOXIDE, ZINC OXIDE | Clutch, Inc. | 4bbde755-e312-123e-e063-6294a90a467f | 2026-08-20 | Warnings | 15FIX9V2JP |
| Psorinum Complex | PHOSPHORUS, SILICEA, SULPHUR, ALOE | BioActive Nutritional, Inc. | d4746927-e6d4-463d-a084-56ffc48d1e67 | 2026-08-20 | Warnings | ETJ7Z6XBU4 |
| Boneforce HP | CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALE | BioActive Nutritional, Inc. | d96ca52b-781d-431c-ad2a-a54fd57eb106 | 2026-08-20 | Warnings | ETJ7Z6XBU4 |
| HEADHUNTER SURF SCREEN SPF 50 SUNSCREEN | ZINC OXIDE,TITANIUM DIOXIDE | Guangzhou Tata Biotechnology Co., Ltd. | 4339df13-77d3-31a1-e063-6394a90a5208 | 2026-08-17 | Warnings | 15FIX9V2JP |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | REMEDYREPACK INC. | e4ed7ad2-cf58-4fdb-bc8c-d89f23b01210 | 2026-08-17 | Warnings, Adverse reactions | 828348 0VE05JYS2P |
| Cerebellum Thalamus A Aurm | CEREBELLUM THALAMUS A AURUM | Uriel Pharmacy Inc. | e1c395b8-9221-401f-8980-c91ff8843458 | 2026-08-17 | Warnings | ETJ7Z6XBU4 |
| Stay Ageless Tinted Mineral Sunscreen | BROAD SPECTRUM SPF30 | HAMBLIN DERMATOLOGY | 5942e64c-416e-7525-e063-6394a90a2839 | 2026-08-17 | Warnings | 15FIX9V2JP |
| Protect Tinted Mineral Sunscreen | BROAD SPECTRUM SPF30 | Opal Day Spa | 5943413a-48e1-0bdf-e063-6294a90a2fff | 2026-08-17 | Warnings | 15FIX9V2JP |
| Stay Ageless Tinted Mineral Sunscreen | BROAD SPECTRUM SPF30 | MedSpa By Beauty Bar LLC | 5943ba3d-688e-9e9c-e063-6294a90afa9a | 2026-08-17 | Warnings | 15FIX9V2JP |
| Stay Ageless Tinted Mineral Sunscreen | BROAD SPECTRUM SPF30 | CORBY, JR., TERRY L. | 594443fd-8e27-4ec6-e063-6294a90a3ff0 | 2026-08-17 | Warnings | 15FIX9V2JP |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | Unit Dose Solutions, Inc. | 53bef1ab-55c0-cc52-e063-6394a90a12b3 | 2026-08-17 | Warnings, Adverse reactions | ANDA208170 828348 0VE05JYS2P |
| Leader Dry Eye Relief Eye Drops | GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400 | CARDINAL HEALTH 110, LLC. DBA LEADER | 2ded4bda-b3c3-4521-8701-5c8446fd148b | 2026-08-17 | Warnings | B697894SGQ 3NXW29V3WO |
| BM BM134 DROPS | ARSENIC ALBUM, HYDRASTIS, MYRISTICA, NITRIC ACID, PAEONIA, RHUS TOX, SILICEA | BM Private Limited | 59023500-89be-cc76-e063-6294a90a6e02 | 2026-08-14 | Warnings | ETJ7Z6XBU4 |
| BM BM173 DROPS | ECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA UREN | BM Private Limited | 59036ca4-e7bb-bbe7-e063-6394a90a410a | 2026-08-14 | Warnings | ETJ7Z6XBU4 |
| TONMYA | CYCLOBENZAPRINE HYDROCHLORIDE | Tonix Medicines, Inc. | 6fa59588-ce9b-48cf-8c5f-725a448f8571 | 2026-08-14 | Warnings, Adverse reactions | 0VE05JYS2P |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Redpharm Drug | 58e6d82b-52fd-cca3-e063-6294a90a1104 | 2026-08-13 | Warnings, Adverse reactions | ANDA208170 828348 0VE05JYS2P |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.