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 74 of 119 · 2,367 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vertra Ehukai Beige Sunscreen Face Stick Broad Spectrum SPF 38TITANIUM DIOXIDEEai-jr 286, Inc303d5d5a-4c7a-1e23-e063-6294a90a0e582025-03-13WarningsExact identifier
unii: 15FIX9V2JP
RID Poison Ivy Rash ReliefCALAMINE AND ZINC OXIDEOystershell Consumer Health Inc.36c3af9a-2646-4427-e063-6394a90a2c5e2025-03-13WarningsExact identifier
unii: 1K09F3G675
AddiclenzASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, BETA VULGARIS, BISPHENOL A, BOLDO, CHELIDONIUM MAJUS, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, TARAXACUM OFFICINALE, ZINCUM METALLICUMDeseret Biologicals, Inc.25036c26-1c21-4e5a-b4db-b8e1774583412025-03-11WarningsExact identifier
unii: 15FIX9V2JP
Bestmade Natural Products BM235ACONITE, CACTUS, CRATAEGUS, ALFALFA, CHIONANTHUS, P. GLYCOLBestmade Natural Products2f82818a-fc34-75e5-e063-6394a90a03012025-03-04WarningsExact identifier
unii: 6DC9Q167V3
MINERAL TINTED SPF 30TITANIUM DIOXIDE, ZINC OXIDEBOTANICAL SCIENCE, INC.2f9e2252-fb54-363f-e063-6294a90aa7c92025-03-04WarningsExact identifier
unii: 15FIX9V2JP
CoTZ Kids Mineral Sun StickTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD2f7225d0-ddfa-e19a-e063-6294a90a52a82025-03-03WarningsExact identifier
unii: 15FIX9V2JP
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLCb0f34220-0657-4868-ae01-014f9300f6222025-03-03Warnings, Adverse reactionsExact identifier
rxcui: 483448
unii: 55JG375S6M
Sun Defense Minerals (Fair)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e21c9f9-acf8-997b-e063-6394a90ada3f2025-03-01WarningsExact identifier
unii: 15FIX9V2JP
Sun Defense Minerals (Medium)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e232e8d-4274-68bc-e063-6394a90a942b2025-03-01WarningsExact identifier
unii: 15FIX9V2JP
PregabalinPREGABALINProficient Rx LP580955ba-86f6-4e86-b0fa-dd44e8828b0e2025-03-01Warnings, Adverse reactionsExact identifier
rxcui: 483450
unii: 55JG375S6M
PregabalinPREGABALINProficient Rx LPa025e4fc-e0c1-4c5b-a1c8-bd8e578a737e2025-03-01Warnings, Adverse reactionsExact identifier
rxcui: 483450
unii: 55JG375S6M
HA Physical Tint SPF 44ZINC OXIDE, TITANIUM DIOXIDEPrivate Label Skin Carea5e19d77-703e-41e0-9a02-19227dc6c8192025-02-27WarningsExact identifier
unii: 15FIX9V2JP
BRUSH ON BLOCK SPF 50 MINERAL TRANSLUCENT ZINC ONLY REFILLZINC OXIDE/TITANIUM DIOXIDESPF Ventures, LLC2f069114-9ca8-aed4-e063-6394a90a46d82025-02-26WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Cream230 NMelaleuca Inc.2f133abb-cad2-2ac8-e063-6294a90aa4802025-02-26WarningsExact identifier
unii: 15FIX9V2JP
Sun Defense Minerals (Tan)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2efb73a6-601d-61a4-e063-6294a90af8252025-02-25WarningsExact identifier
unii: 15FIX9V2JP
Sun Defense Minerals (Tan)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2ee82379-6609-fd8e-e063-6294a90acf6c2025-02-24WarningsExact identifier
unii: 15FIX9V2JP
REPAIRWEAR UPLIFTING FIRMING BROAD SPECTUM SPF 15 - NORMAL COMBO TO COMBINATION oilyOCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDECLINIQUE LABORATORIES LLC10edc0c1-9359-4c7a-a56e-bad06fea00562025-02-20WarningsExact identifier
unii: 15FIX9V2JP
FEELSHION Glycolic Acid Exfoliating Face PadsPROPYLENE GLYCOL,ARGININE,LACTIC ACID,SALICYLIC ACID,GLYCOLIC ACIDBeijing JUNGE Technology Co., Ltd.2e79678c-1ce4-25cf-e063-6394a90a133c2025-02-19WarningsExact identifier
unii: 6DC9Q167V3
Neutrogena Healthy Skin Invisibly Radiant UV Primer SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC20cd4d96-2046-3a50-e063-6394a90a12192025-02-18WarningsExact identifier
unii: 15FIX9V2JP
Sun Defense Minerals (Sheer)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e2082aa-5ae3-2c04-e063-6294a90a140b2025-02-14WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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