FDA.reportPublic FDA data

NDC 51079-199-01 - 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
51079-199
Requested NDC
51079-199-01
Package NDCs from labels
51079-199-01, 51079-199-20
Manufacturer
Mylan Institutional Inc.
Effective date
2021-12-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Celecoxib - Mylan Institutional Inc.Mylan Institutional Inc.2021-12-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-199-01EA - Each51079-199b812149d-34e7-404c-ba1e-38efbb220cba12015-04-03
51079-199-20EA - Each51079-1991bf82f57-6754-42bf-ad84-8bffabdf5c5612015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CELECOXIBACTIVE INGREDIENTJCX84Q7J1LCELECOXIB CAPSULE [MYLAN INSTITUTIONAL INC.]1
CELECOXIBACTIVE MOIETYJCX84Q7J1LCELECOXIB CAPSULE [MYLAN INSTITUTIONAL INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CELECOXIB CAPSULE [MYLAN INSTITUTIONAL INC.]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHCELECOXIB CAPSULE [MYLAN INSTITUTIONAL INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCELECOXIB CAPSULE [MYLAN INSTITUTIONAL INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCELECOXIB CAPSULE [MYLAN INSTITUTIONAL INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCELECOXIB CAPSULE [MYLAN INSTITUTIONAL INC.]1
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYCELECOXIB CAPSULE [MYLAN INSTITUTIONAL INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACELECOXIB CAPSULE [MYLAN INSTITUTIONAL INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CELECOXIB CAPSULE [MYLAN INSTITUTIONAL INC.]1
GELATININACTIVE INGREDIENT2G86QN327LCELECOXIB CAPSULE [MYLAN INSTITUTIONAL INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCELECOXIB CAPSULE [MYLAN INSTITUTIONAL INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CELECOXIB CAPSULE [MYLAN INSTITUTIONAL INC.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ECELECOXIB CAPSULE [MYLAN INSTITUTIONAL INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CELECOXIB CAPSULE [MYLAN INSTITUTIONAL INC.]1
SHELLACINACTIVE INGREDIENT46N107B71OCELECOXIB CAPSULE [MYLAN INSTITUTIONAL INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CELECOXIB CAPSULE [MYLAN INSTITUTIONAL INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCELECOXIB CAPSULE [MYLAN INSTITUTIONAL INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCELECOXIB CAPSULE [MYLAN INSTITUTIONAL INC.]1

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 145 · 2,890 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
CelecoxibCELECOXIBMajor Pharmaceuticals3a1eadd5-c0a7-473e-bde0-6b9450d11c952026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
CelecoxibCELECOXIBREMEDYREPACK INC.c96509cc-47f4-44f8-9f7e-4e49cc3d53482026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBDirectRxe0f3aacf-df5d-dad7-e053-2995a90ac5eb2026-08-27Warnings, Adverse reactionsExact identifier
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
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Incd2d1428a-c8b5-9529-e053-2995a90a23432026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
S12 AIRBORNEALFALFA, ALLIUM SATIVUM, ARSENICUM IODATUM, BARLEY, BETULA PUBESCENS, BROWN RICE, CORN GRAIN, EUPHRASIA OFFICINALIS, FEATHER MIX, HAIR MIX, HISTAMINUM, HOUSE DUST MITE, LOLIUM PERENNE, OAT, PERFOLIATE HONEYSUCKLE, PHLEUM PRATENSE, POLLEN MIX, RYE, SABADILLA, SILICEA, SKIN MIX, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TEREBINTHINA, WHEATApex Energetics Inc.bb0036c3-1e4d-5750-e053-2995a90ae8952026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
CelecoxibCELECOXIBA-S Medication Solutionse84d67c8-010d-495c-8691-ae16d0698f8d2026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
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
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
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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