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 | PD-Rx Pharmaceuticals, Inc. | 4eaa675a-c24c-4043-8fdf-9d59e5e4f4d5 | 2026-01-22 | Warnings, Adverse reactions | ANDA208170 828320 0VE05JYS2P |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 13C | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | be9f7608-cfaa-4b16-83dd-0580047af56c | 2026-01-21 | Warnings | 15FIX9V2JP |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 15C | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 6b27df44-c441-4ae8-a1b0-a9cf2fff6f21 | 2026-01-21 | Warnings | 15FIX9V2JP |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 3c295f6b-6202-a2e1-e063-6394a90a9a60 | 2026-01-21 | Warnings | 15FIX9V2JP |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 19C | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | b2eee48f-b644-403c-a57e-04a1491bc386 | 2026-01-21 | Warnings | 15FIX9V2JP |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | ebcc2c6c-a039-48d5-8c1c-5b347254c4c2 | 2026-01-21 | Warnings | 15FIX9V2JP |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 6967f8bc-3092-44a9-926a-6c11676425e5 | 2026-01-21 | Warnings | 15FIX9V2JP |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 23W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 37d4d8c1-e76b-48a3-9a13-f0543af1b28f | 2026-01-21 | Warnings | 15FIX9V2JP |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 24W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | fa5046f2-a6db-4ac3-a78f-1b5df075d7e8 | 2026-01-21 | Warnings | 15FIX9V2JP |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 25N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 0c5fc63f-1899-4406-944a-1cdcdf8b4277 | 2026-01-21 | Warnings | 15FIX9V2JP |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27C | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 58a84ecd-3f27-40fc-8e0b-e29192679e6b | 2026-01-21 | Warnings | 15FIX9V2JP |
| BioMicroneedle PDRN Cream | SILICON DIOXIDE | Guangzhou Shengyanghui Industrial Trading Co., Ltd | 48e2edae-94ea-c42e-e063-6394a90a907b | 2026-01-21 | Warnings | ETJ7Z6XBU4 |
| sunscreen | TITANIUM DIOXIDE | Guangdong Zhoubang Biotechnology Co., Ltd | 48f13b1c-8104-881b-e063-6394a90a816d | 2026-01-21 | Warnings | 15FIX9V2JP |
| Inflammation I | ECHINACEA (ANGUSTIFOLIA), NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, FERRUM PHOSPHORICUM, NITRICUM ACIDUM, OLEANDER, SILICEA | BioActive Nutritional, Inc. | 3cb12181-ae7e-45c7-a1b1-e1952f36f8c3 | 2026-01-21 | Warnings | ETJ7Z6XBU4 |
| Welmedix HomeCare PRO Fragile Skin Dual Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Welmedix LLC | 48da4589-0f5a-c25b-e063-6394a90ac18b | 2026-01-20 | Warnings | 15FIX9V2JP |
| KONEUK SUNSCREEN SPF50 | KONEUK SUNSCREEN SPF50 | Guangzhou Meixi Biotechnology Co., Ltd. | 48dd7f6e-2a4d-2c92-e063-6294a90a4255 | 2026-01-20 | Warnings | 15FIX9V2JP |
| Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2CR Cool Fosy | OCTISALATE, TITANIUM DIOXIDE | Parfums Christian Dior | 12edec55-2414-4bbd-bc96-4599a96b96ac | 2026-01-19 | Warnings | 15FIX9V2JP |
| OUTER REEF MINERAL SUNSCREEN SPF 30 | TITANIUM DIOXIDE | Coral Reef Park Co., Inc. | 86ee2fdf-8a88-44e6-b12a-36a92360477a | 2026-01-19 | Warnings | 15FIX9V2JP |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | PHOENIX RX LLC | 48c33e51-db07-af68-e063-6294a90a897e | 2026-01-19 | Warnings, Adverse reactions | 0VE05JYS2P |
| CURESHIELD MANICURE SUNSCREEN | ZINC OXIDE, TITANIUM DIOXIDE | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 48b4fad7-073d-d983-e063-6394a90ae314 | 2026-01-18 | Warnings | 15FIX9V2JP |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.