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 |
|---|---|---|---|---|---|---|
| Warts | ANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUM | Newton Laboratories, Inc. | f0315c9e-8922-c0b5-e053-2a95a90ae54e | 2022-12-19 | Warnings | ETJ7Z6XBU4 |
| Warts | ANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUM | Newton Laboratories, Inc. | f031e256-fca5-3939-e053-2995a90a4fe6 | 2022-12-19 | Warnings | ETJ7Z6XBU4 |
| SILICEA | SILICON DIOXIDE | Hyland's Inc. | 86da31ff-b39a-4ac2-92e5-810f6d8888e6 | 2022-12-19 | Warnings | ETJ7Z6XBU4 |
| Warts | ANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUM | Newton Laboratories, Inc. | f0328097-e5d2-3532-e053-2a95a90a93f0 | 2022-12-19 | Warnings | ETJ7Z6XBU4 |
| Warts | ANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUM | Newton Laboratories, Inc. | f032e7bb-a6fd-2951-e053-2a95a90a8c3a | 2022-12-19 | Warnings | ETJ7Z6XBU4 |
| Silicea | SILICON DIOXIDE | Hyland's Inc. | d3c426ab-1a61-3494-e053-2a95a90a9677 | 2022-12-14 | Warnings | ETJ7Z6XBU4 |
| Silicea | SILICEA | Hahnemann Laboratories, INC. | efcdc393-5dab-38d1-e053-2995a90acb2e | 2022-12-14 | ETJ7Z6XBU4 | |
| Defend Cold and Mucus | BRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PATENS, RUMEX CRISPUS ROOT, AND SILICON DIOXIDE | Hyland's Inc. | bb851be1-0528-4199-91e7-e09f994b2862 | 2022-12-12 | Warnings | ETJ7Z6XBU4 |
| Miranda Castros healing cell salts for bones, hair, nails and teeth Homeopathic Combination | CALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEA | OHM PHARMA INC. | 044a7174-f7a3-490f-9cad-01f2665d7575 | 2022-12-02 | Warnings | ETJ7Z6XBU4 |
| Refresh Digital PF | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80 | Allergan, Inc. | 97e83e68-6374-4df4-93f6-d707fc32748d | 2022-11-28 | Warnings | 6OZP39ZG8H |
| Refresh Digital | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80 | Allergan, Inc. | b2bd34d4-fab9-4f4b-9be2-5d30b55f5b81 | 2022-11-28 | Warnings | 6OZP39ZG8H |
| 4 Kids Cold and Mucus Nighttime | EUPHRASIA STRICTA,SILICON DIOXIDE, RUMEX CRISPUS ROOT, ANEMONE PULSATILLA, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ONION, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA, ARABICA COFFEE BEAN, CALCIUM SULFIDE AND SULFUR | Hyland's Inc. | 6f7b2585-2f0e-5938-e053-2a91aa0aa9d1 | 2022-11-21 | Warnings | ETJ7Z6XBU4 |
| 4 Kids Complete Cold and Mucus | BRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDE | Hyland's Inc. | ef39fe3d-a42d-4baa-9199-91f664feb432 | 2022-11-21 | Warnings | ETJ7Z6XBU4 |
| REFRESH OPTIVE Advanced | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80 | Allergan, Inc. | ebd0839e-2e1d-4e0e-986c-19f1f5c76358 | 2022-09-15 | Warnings | 6OZP39ZG8H |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | Asclemed USA, Inc. | 2a6b2ad9-307a-4976-98b7-1b96e0408da7 | 2022-09-14 | Warnings, Adverse reactions | ANDA208170 828299 0VE05JYS2P |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Asclemed USA, Inc. | f8dec4e2-3151-4a79-b194-a11a57ada0b6 | 2022-09-03 | Warnings, Adverse reactions | 828299 828320 828348 0VE05JYS2P |
| REFRESH OPTIVE Advanced | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80 | Allergan, Inc. | aaa943e4-7c38-4c5a-b7c0-5a656d8cafc0 | 2022-09-01 | Warnings | 6OZP39ZG8H |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Solco Healthcare U.S., LLC | f558863b-ea3f-4e4b-85e9-edb2573e7151 | 2022-08-22 | Warnings, Adverse reactions | 828320 828348 0VE05JYS2P |
| Hendel Periodontal and Tooth Pain Relief | SODIUM BORATE, TRIBASIC CALCIUM PHOSPHATE, MERCURIUS SOLUBILIS, AND SILICON DIOXIDE | MediNatura Inc | f34e9f77-69fd-4c7f-9eea-2d721a4d27fb | 2022-08-22 | Warnings | ETJ7Z6XBU4 |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | Asclemed USA, Inc. | 751f0d33-ceff-40b0-9329-9125f176e06a | 2022-07-29 | Warnings, Adverse reactions | ANDA208170 828320 0VE05JYS2P |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.