FDA.reportPublic FDA data

NDC 80425-0397-01 - 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
80425-0397
Requested NDC
80425-0397-01
Package NDCs from labels
80425-0397-3, 80425-0397-2, 80425-0397-1, 80425-0397-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2024-06-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Pregabalin - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2024-06-05HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0397-1Pregabalin30 in 1 BOTTLECAPSULE302
80425-0397-2Pregabalin60 in 1 BOTTLECAPSULE602
80425-0397-3Pregabalin90 in 1 BOTTLECAPSULE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0397PREGABALIN CAPSULE [ADVANCED RX OF TENNESSEE, LLC]2Current NDC, 3 package rows20240606_1a15cd11-0db9-2bc8-e063-6394a90a11fb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0397-1EA - Each80425-03973c72220d-e85e-4787-a30e-d5eb63357c0612024-07-12
80425-0397-2EA - Each80425-03973fcf1d01-f037-44e6-aa3b-68cb8058e64412024-07-12
80425-0397-3EA - Each80425-0397952f1e6a-ae82-4b78-a129-af4fcc77997912024-07-12

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 4 of 118 · 2,341 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Revitalize Energizing Eye DropsNAPHAZOLINE HYDROCHLORIDE ,PROPYLENE GLYCOLRevitalize Energy Inc.518aac87-1642-4b2f-bca1-b74d21261eea2026-07-16WarningsExact identifier
unii: 6DC9Q167V3
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DERMIO DERMATOLOGY LLC562f5b0d-6a10-305d-e063-6394a90a59802026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30Suzanne's Skin2soul LLC562fbaa6-f93a-5ec4-e063-6294a90a96342026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Aussie Betta Tallow Sunscreen SPF50 SPF50TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENAUSSIE BETTA HEALTHY CARE PTY LTD56007d82-ff5b-6c26-e063-6294a90a09b62026-07-07WarningsExact identifier
unii: 15FIX9V2JP
EELHOE Body Coverage PerfectorTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5610c3b7-456b-3bc1-e063-6394a90a3fa82026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Emerald Aesthetics LLC55f88dd1-346c-22a5-e063-6294a90a711f2026-07-06WarningsExact identifier
unii: 15FIX9V2JP
OHUI Ultimate Cover CC Cushion Compact 02 Natural BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d307471c-6cc6-ce48-e053-2995a90a3e022026-07-02WarningsExact identifier
unii: 15FIX9V2JP
PregabalinPREGABALINSt. Mary's Medical Park Pharmacy9235cd08-7a25-4b81-e053-2995a90a539c2026-07-02Warnings, Adverse reactionsExact identifier
application number: ANDA208677
rxcui: 483448
unii: 55JG375S6M
PregabalinPREGABALINProficient Rx LP189b610e-3e29-42fa-ab6e-73effbe0d0542026-07-02Warnings, Adverse reactionsExact identifier
rxcui: 483440
rxcui: 483450
unii: 55JG375S6M
Evereden Fluid Silk Mineral Sunscreen PRO SPF50TITANIUM DIOXIDE, ZINC OXIDEEden Brands Inc.2cb7773f-9a05-ad02-e063-6294a90af0242026-07-01WarningsExact identifier
unii: 15FIX9V2JP
PregabalinPREGABALINSt. Mary's Medical Park Pharmacy35d3486c-c6ea-4d31-e063-6294a90a12192026-06-30Warnings, Adverse reactionsExact identifier
rxcui: 483438
unii: 55JG375S6M
PregabalinPREGABALINSt. Mary's Medical Park Pharmacy35d387dd-bc7f-37a4-e063-6394a90abbbb2026-06-30Warnings, Adverse reactionsExact identifier
rxcui: 483440
unii: 55JG375S6M
OHUI Ultimate Cover CC Cushion Compact 01 Light BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d2f9c54b-ac4e-5141-e053-2a95a90aa2b82026-06-30WarningsExact identifier
unii: 15FIX9V2JP
TOCOBO Blur Finish Sun Cushion Cotton BlueHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEPICTON Co., Ltd.4d6ddee3-9a76-6c9c-e063-6394a90a15292026-06-29WarningsExact identifier
unii: 15FIX9V2JP
Earth Baby Broad Spectrum SPF 30SUNSCREENEarth Baby, Inc.42556876-74ea-38e6-e054-00144ff8d46c2026-06-28WarningsExact identifier
unii: 15FIX9V2JP
Sun Does Matter Daily Face SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDESundoesmatter Company Inc.553687d8-d4e1-8361-e063-6294a90a24fe2026-06-27WarningsExact identifier
unii: 15FIX9V2JP
PregabalinPREGABALINSt. Mary's Medical Park Pharmacy36c3dda1-67fb-4dc5-e063-6294a90a1c3e2026-06-26Warnings, Adverse reactionsExact identifier
rxcui: 483448
unii: 55JG375S6M
PregabalinPREGABALINSt. Mary's Medical Park Pharmacy2c62e63a-fe81-a463-e063-6394a90a65ee2026-06-26Warnings, Adverse reactionsExact identifier
rxcui: 483448
unii: 55JG375S6M
Ivory Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f25ba-61d5-6a94-e063-6394a90a46e92026-06-26WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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