FDA.reportPublic FDA data

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 table
LabelManufacturerEffective dateType
Pregabalin - REMEDYREPACK INC.REMEDYREPACK INC.2026-08-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3597-0Pregabalin90 in 1 BOTTLE, PLASTICCAPSULE908
70518-3597-1Pregabalin60 in 1 BOTTLE, PLASTICCAPSULE608
70518-3597-2Pregabalin90 in 1 BOTTLE, PLASTICCAPSULE908
70518-3597-3Pregabalin60 in 1 BOTTLE, PLASTICCAPSULE608

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3597PREGABALIN CAPSULE [REMEDYREPACK INC.]5Current NDC, Legacy NDC, 4 package rows20241218_12309847-0857-4ff7-a7e7-edeadc3dfb61.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-3597-0EA - Each70518-3597d1f128c7-0e21-4032-9628-d267b2b46f4212026-01-08
70518-3597-1EA - Each70518-359705f433e5-ae15-499d-a974-444416d5960612026-01-08
70518-3597-2EA - Each70518-3597e26c2135-c861-4292-b7bd-4dd8ecd006e612026-01-08

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.

Matched openFDA labels page 117 of 119 · 2,362 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 ToffeeOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS50138c51-f424-4b07-b3eb-c0d31d8ecf162021-06-29WarningsExact identifier
unii: 15FIX9V2JP
No7 Protect and Perfect Intense Advanced All in One Foundation SPF 50 CameoOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS01a861b9-0ab6-4c4c-a407-428a64509a1c2021-06-29WarningsExact identifier
unii: 15FIX9V2JP
No7 Protect and Perfect Intense Advanced All in One Foundation SPF 50 BirchOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SASd5431d62-fded-4cdc-81a1-5b5e3eb928732021-06-29WarningsExact identifier
unii: 15FIX9V2JP
No7 Protect and Perfect Intense Advanced All in One Foundation SPF 50 TawnyOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS52c3378f-6b99-42fa-900e-8a693864c6152021-06-29WarningsExact identifier
unii: 15FIX9V2JP
PREGABALINPREGABALINAsclemed USA, Inc.69b8a843-a3a8-4d76-8418-f482886250302020-06-25Warnings, Adverse reactionsExact identifier
rxcui: 483440
rxcui: 483444
rxcui: 483442
rxcui: 577127
rxcui: 483448
rxcui: 483438
rxcui: 483450
rxcui: 483446
unii: 55JG375S6M
LyricaPREGABALINParke-Davis Div of Pfizer Inc60185c88-ecfd-46f9-adb9-b97c6b00a5532020-06-15Warnings, Adverse reactionsExact identifier
rxcui: 483440
rxcui: 483444
rxcui: 483442
rxcui: 577127
rxcui: 483448
rxcui: 483438
rxcui: 483450
rxcui: 483446
unii: 55JG375S6M
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Cool VanillaOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SASd701c221-9f68-47ff-b766-2f4f1998649f2019-10-08WarningsExact identifier
unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 AmberOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS7f5e6872-4d26-410e-8afe-16a016f9a3992019-10-08WarningsExact identifier
unii: 15FIX9V2JP
No7 Perfect and Perfect Advanced All in One Foundation SPF 50 Warm IvoryOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS1124ba7d-a328-409b-8c88-e74bb3e501f52019-10-08WarningsExact identifier
unii: 15FIX9V2JP
No7 Perfect and Perfect Advanced All in One Foundation SPF 50 HoneyOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS9c407dc7-fcde-4660-9a06-57bd8a6b867d2019-10-08WarningsExact identifier
unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 ChestnutOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SASf07e8bb2-30ae-4337-ad60-84f55f2ff3542019-10-08WarningsExact identifier
unii: 15FIX9V2JP
PREGABALINPREGABALINProficient Rx LP4624c58f-8f77-48fa-be0f-fca4010cc8ae2019-10-01Warnings, Adverse reactionsExact identifier
rxcui: 483438
unii: 55JG375S6M
PREGABALINPREGABALINProficient Rx LP6022939f-92a8-4cb4-9f04-f237a4d73f6f2019-10-01Warnings, Adverse reactionsExact identifier
rxcui: 483450
unii: 55JG375S6M
CLE CCC Golden Medium DeepTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.b7a4847f-b84d-4f36-8787-104eccd838a02018-12-03WarningsExact identifier
unii: 15FIX9V2JP
CLE CCC Warm Medium DeepTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.229c20a3-6288-4ac3-9098-6d1622e906ab2018-11-29WarningsExact identifier
unii: 15FIX9V2JP
CLE CCC Warm Medium LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.fc90fb8a-44b3-47cd-882e-94ed324ed3892018-11-27WarningsExact identifier
unii: 15FIX9V2JP
CLE CCC Warm MediumTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.b585f216-4234-47c5-9a6b-8b133ef48aae2018-11-27WarningsExact identifier
unii: 15FIX9V2JP
CLE CCC Warm LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.14891e26-b3b6-4545-99b1-da914b7f56292018-11-24WarningsExact identifier
unii: 15FIX9V2JP
AdditoxTRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMBioActive Nutritional, Inc.319ee2fe-58e3-495e-bf0d-df201f6fbb1c2018-07-18WarningsExact identifier
unii: 15FIX9V2JP
Your Name Cosmetics Mineral Sheet Tint Broad Spectrum SPF 20YOUR NAME COSMETICS MINERAL SHEET TINT BROAD SPECTRUM SPF 20Mana Products657d5090-30a8-46d0-879d-469178aa234d2018-01-25WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.