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 | Tris Pharma Inc | 62aa850d-199c-44d5-a730-45f43efa850e | 2022-11-30 | Warnings, Adverse reactions | 483440 483444 577127 483448 483438 483450 483446 55JG375S6M |
| Pregabalin | PREGABALIN | Aphena Pharma Solutions - Tennessee, LLC | df80e09f-3d57-47a0-ba58-bb79e9ba1953 | 2022-11-29 | Warnings, Adverse reactions | 483450 55JG375S6M |
| Pregabalin | PREGABALIN | Asclemed USA, Inc. | 3d2464fb-b3ac-496e-b8a5-c2e8a902ce29 | 2022-10-12 | Warnings, Adverse reactions | 483440 483444 483442 577127 483448 483438 483450 483446 55JG375S6M |
| Pregabalin Extended Release | PREGABALIN | ScieGen Pharmaceuticals, INC. | 1544a657-353c-47f8-96ac-a63fa78373f0 | 2022-09-19 | Warnings, Adverse reactions | 55JG375S6M |
| Pregabalin | PREGABALIN | Proficient Rx LP | 65311ae9-e440-4650-b1b1-6f4495fda93c | 2022-09-01 | Warnings, Adverse reactions | 483440 55JG375S6M |
| Pregabalin | PREGABALIN | Proficient Rx LP | c7986739-3fc9-4a1d-8dd6-2e11cf1f3610 | 2022-08-01 | Warnings, Adverse reactions | 483450 55JG375S6M |
| Pregabalin | PREGABALIN | Proficient Rx LP | 68829d7b-ab40-429e-92dc-91f8a0d49afd | 2022-07-01 | Warnings, Adverse reactions | ANDA207799 483440 55JG375S6M |
| PREGABALIN | PREGABALIN | Patrin Pharma, Inc. | d92c94e5-e542-4177-afa8-fa00ba17634c | 2022-06-21 | Warnings, Adverse reactions | 55JG375S6M |
| Pregabalin | PREGABALIN | Proficient Rx LP | 89b8c2d2-4a99-4b97-8b82-c0c36cd0df1b | 2022-06-01 | Warnings, Adverse reactions | 483448 55JG375S6M |
| Addiclenz | BETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM | Deseret Biologicals, Inc. | e39235ea-2a2f-44a7-92d6-fb1d428ebabd | 2022-05-12 | Warnings | 15FIX9V2JP |
| Pregabalin | PREGABALIN | Proficient Rx LP | a1545bbb-b337-4760-ab4c-fb76ab019337 | 2022-05-02 | Warnings, Adverse reactions | ANDA207799 483450 55JG375S6M |
| Pregabalin | PREGABALIN | Proficient Rx LP | 1503dd3b-688b-4702-8fc1-954b5ffe4235 | 2022-05-02 | Warnings, Adverse reactions | ANDA207799 483438 55JG375S6M |
| Pregabalin | PREGABALIN | Proficient Rx LP | 9b1472ac-8b79-4f22-ae50-3b0942bd62b1 | 2022-04-01 | Warnings, Adverse reactions | 483440 483444 483442 577127 483448 483438 483450 483446 55JG375S6M |
| Pregabalin | PREGABALIN | Proficient Rx LP | d58c0808-2ff9-4ce6-9c07-56f723592385 | 2022-04-01 | Warnings, Adverse reactions | 483450 55JG375S6M |
| Pregabalin | PREGABALIN | Proficient Rx LP | a0f2b8af-0a04-4db0-adb3-d9d9369223d9 | 2022-04-01 | Warnings, Adverse reactions | 483440 55JG375S6M |
| No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Warm Ivory | OCTINOXATE, TITANIUM DIOXIDE | BCM Cosmetique SAS | 97e7ece8-a705-4988-ba52-6d3f11573521 | 2021-12-01 | Warnings | 15FIX9V2JP |
| No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Chestnut | OCTINOXATE, TITANIUM DIOXIDE | BCM Cosmetique SAS | 6a44f926-11b4-4bc4-8d5d-721a89c4f0cc | 2021-11-09 | Warnings | 15FIX9V2JP |
| No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Hazelnut | OCTINOXATE, TITANIUM DIOXIDE | BCM Cosmetique SAS | b58af664-b0fd-4585-8417-7c20954d7aff | 2021-11-09 | Warnings | 15FIX9V2JP |
| No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Umber | OCTINOXATE, TITANIUM DIOXIDE | BCM Cosmetique SAS | 7bbd1334-fae8-4274-b927-a099af764345 | 2021-11-09 | Warnings | 15FIX9V2JP |
| No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cedar | OCTINOXATE, TITANIUM DIOXIDE | BCM Cosmetique SAS | 970571f9-3d6b-46ae-a668-745de1911fa2 | 2021-11-09 | Warnings | 15FIX9V2JP |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.