FDA.reportPublic FDA data

NDC 68180-397-03 - celecoxib

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
68180-397
Requested NDC
68180-397-03
Package NDCs from labels
68180-397-01, 68180-397-02, 68180-397-03
Manufacturer
Lupin Pharmaceuticals, Inc. | LUPIN LIMITED
Effective date
2023-12-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
celecoxib - Lupin Pharmaceuticals, Inc. | LUPIN LIMITEDLupin Pharmaceuticals, Inc. | LUPIN LIMITED2023-12-08HUMAN PRESCRIPTION DRUG LABEL
celecoxib - NCS HealthCare of KY, Inc dba Vangard LabsNCS HealthCare of KY, Inc dba Vangard Labs2019-07-17HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-397-01celecoxib100 in 1 BOTTLECAPSULE10015
68180-397-02celecoxib500 in 1 BOTTLECAPSULE50015
68180-397-03celecoxib1000 in 1 BOTTLECAPSULE100015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-397CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.]15Legacy NDC, 3 package rows20231209_560017b1-daf8-464e-b86f-0a75c78002ec.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-397-01EA - Each68180-3972d3bbe71-91d5-4eac-8a08-97be2e68472712016-04-04
68180-397-02EA - Each68180-397bd5fe804-c65b-411e-acc0-fe9b1394515e12015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CELECOXIBACTIVE INGREDIENTJCX84Q7J1LCELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
CELECOXIBACTIVE MOIETYJCX84Q7J1LCELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LCELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TCELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
POVIDONE K30INACTIVE INGREDIENTU725QWY32XCELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
SHELLACINACTIVE INGREDIENT46N107B71OCELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.]3

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 1 of 115 · 2,295 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CelecoxibCELECOXIBMajor Pharmaceuticals3a1eadd5-c0a7-473e-bde0-6b9450d11c952026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
rxcui: 205322
unii: JCX84Q7J1L
CelecoxibCELECOXIBREMEDYREPACK INC.c96509cc-47f4-44f8-9f7e-4e49cc3d53482026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CelecoxibCELECOXIBDirectRxe0f3aacf-df5d-dad7-e053-2995a90ac5eb2026-08-27Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
CelecoxibCELECOXIBA-S Medication Solutionse84d67c8-010d-495c-8691-ae16d0698f8d2026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205322
unii: JCX84Q7J1L
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
CelecoxibCELECOXIBSt. Mary's Medical Park Pharmacy59f495e8-3cea-9d98-e063-6394a90a89d42026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205322
unii: JCX84Q7J1L
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
CelecoxibCELECOXIBMullan Pharmaceutical Inc.643e177f-216d-4dfa-824a-7516a488304e2026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 686379
rxcui: 205323
rxcui: 205322
unii: JCX84Q7J1L
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: 6DC9Q167V3
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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