NDC 70518-3597-01 - Pregabalin
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
- 70518-3597
- Requested NDC
- 70518-3597-01
- Package NDCs from labels
- 70518-3597-0, 70518-3597-1, 70518-3597-2, 70518-3597-3, 70518-3597-01
- Manufacturer
- REMEDYREPACK INC.
- Effective date
- 2026-08-14
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Pregabalin - REMEDYREPACK INC. | REMEDYREPACK INC. | 2026-08-14 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70518-3597-0 | Pregabalin | 90 in 1 BOTTLE, PLASTIC | CAPSULE | 90 | 8 | |
| 70518-3597-1 | Pregabalin | 60 in 1 BOTTLE, PLASTIC | CAPSULE | 60 | 8 | |
| 70518-3597-2 | Pregabalin | 90 in 1 BOTTLE, PLASTIC | CAPSULE | 90 | 8 | |
| 70518-3597-3 | Pregabalin | 60 in 1 BOTTLE, PLASTIC | CAPSULE | 60 | 8 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70518-3597 | PREGABALIN CAPSULE [REMEDYREPACK INC.] | 5 | Current NDC, Legacy NDC, 4 package rows | 20241218_12309847-0857-4ff7-a7e7-edeadc3dfb61.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70518-3597-0 | EA - Each | 70518-3597 | d1f128c7-0e21-4032-9628-d267b2b46f42 | 1 | 2026-01-08 |
| 70518-3597-1 | EA - Each | 70518-3597 | 05f433e5-ae15-499d-a974-444416d59606 | 1 | 2026-01-08 |
| 70518-3597-2 | EA - Each | 70518-3597 | e26c2135-c861-4292-b7bd-4dd8ecd006e6 | 1 | 2026-01-08 |
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 |
|---|---|---|---|---|---|---|
| PREGABALIN | PREGABALIN | Cadila Pharmaceuticals Limited | 170c0c95-2ee8-4dff-bbd6-b87a21e8cf81 | 2025-09-12 | Warnings, Adverse reactions | 483440 483444 483442 577127 483448 483438 483450 483446 55JG375S6M |
| Pregabalin | PREGABALIN | Preferred Pharmaceuticals, Inc. | ceedde96-fdaf-4708-9ca1-e48e052cde75 | 2025-09-12 | Warnings, Adverse reactions | 483438 55JG375S6M |
| Pregabalin | PREGABALIN | Preferred Pharmaceuticals Inc. | a0da0534-b386-4c93-ae89-03b0e3325e02 | 2025-09-11 | Warnings, Adverse reactions | ANDA207799 483450 55JG375S6M |
| Pregabalin | PREGABALIN | Preferred Pharmaceuticals, Inc. | 1760ccdc-46f7-4182-a563-96b13212cb7e | 2025-09-11 | Warnings, Adverse reactions | 483450 55JG375S6M |
| sunscreen | TITANIUM DIOXIDE(NANO) | Mingyu (guangdong) Cosmetics Technology Co., Ltd | 3e6fe9f3-486b-bba7-e063-6294a90adf37 | 2025-09-10 | Warnings | 15FIX9V2JP |
| Pregabalin | PREGABALIN | Preferred Pharmaceuticals, Inc. | 3dbfd868-8408-4514-ba1c-04a5d095c16a | 2025-09-10 | Warnings, Adverse reactions | 483448 55JG375S6M |
| Pregabalin | PREGABALIN | Aphena Pharma Solutions - Tennessee, LLC | 31e7caf6-0a8b-f343-e063-6294a90ad729 | 2025-09-08 | Warnings, Adverse reactions | 483438 55JG375S6M |
| PHOFAY Matte Sunscreen Liquid Foundation SPF 30 5 | ENSULIZOLE ,HOMOSALATE ,OCTINOXATE,TITANIUM DIOXIDE | Hangzhou Jingshen Trading Co., Ltd. | 3dbb07e2-971c-284d-e063-6294a90a437f | 2025-09-06 | Warnings | 15FIX9V2JP |
| PHOFAY Matte Sunscreen Liquid Foundation SPF 30 6 | ENSULIZOLE,HOMOSALATE ,OCTINOXATE ,TITANIUM DIOXIDE | Hangzhou Jingshen Trading Co., Ltd. | 3e069cb2-c4c5-abf5-e063-6394a90a56b0 | 2025-09-06 | Warnings | 15FIX9V2JP |
| Powder | TITANIUM DIOXIDE | Oxygen Development LLC | 08b52f29-c1a0-c673-e063-6294a90a9a7a | 2025-09-05 | Warnings | 15FIX9V2JP 1K09F3G675 |
| Powder | TITANIUM DIOXIDE | Oxygen Development LLC | 08b8003f-40be-3380-e063-6294a90a4f6b | 2025-09-05 | Warnings | 15FIX9V2JP 1K09F3G675 |
| PREGABALIN | PREGABALIN | Rising Pharma Holdings, Inc. | dbebfa61-0685-41b4-8364-00b8d8b73714 | 2025-09-05 | Warnings, Adverse reactions | 483440 483444 483442 577127 483448 483438 483450 483446 55JG375S6M |
| PHOFAY Matte Sunscreen Liquid Foundation SPF 30, 1 | ENSULIZOLE, HOMOSALATE, OCTINOXATE, TITANIUM DIOXIDE | Hangzhou Jingshen Trading Co., Ltd. | 18130858-429c-4ed4-a75b-5bc014481250 | 2025-09-04 | Warnings | 15FIX9V2JP |
| Dolce and Gabbana Everlast Foundation SPF 20 38C Deep | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | 0358a87d-8002-4f3e-851a-3a582d356edf | 2025-09-03 | Warnings | 15FIX9V2JP |
| Dolce and Gabbana Everlast Foundation SPF 20 39N Deep | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | 34dfc4c5-44f7-4531-97ba-8846ebe14724 | 2025-09-03 | Warnings | 15FIX9V2JP |
| Dolce and Gabbana Everlast Foundation SPF 20 40C Deep | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | cf4b6f45-d4ae-4665-87b4-c5af4910befa | 2025-09-03 | Warnings | 15FIX9V2JP |
| TRIMO SAN | OXYQUINOLINE SULFATE AND SODIUM LAURYL SULFATE | CooperSurgical, Inc. | 1e4a1caa-e6ba-44ef-8347-07e6385a7c9e | 2025-09-03 | Warnings | 368GB5141J |
| Pure6 ManiShield Hand Screen | ZINC OXIDE, TITANIUM DIOXIDE | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 3abcb6ba-1de8-55e7-e063-6294a90aecf1 | 2025-09-02 | Warnings | 15FIX9V2JP |
| toty Ilumina CC Creamy Compact 6N | TITANIUM DIOXIDE | Chipican LLC | 3da732e7-19b0-3195-e063-6394a90a9a0c | 2025-09-01 | Warnings | 15FIX9V2JP |
| PHOFAY Matte Sunscreen Liquid Foundation SPF 30 4 | ENSULIZOLE ,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDE | Hangzhou Jingshen Trading Co., Ltd. | 3dba1360-f70f-e450-e063-6394a90a8c9f | 2025-09-01 | Warnings | 15FIX9V2JP |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.