FDA.reportPublic FDA data

NDC 68084-976-33 - 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
68084-976
Requested NDC
68084-976-33
Package NDCs from labels
68084-976-11, 68084-976-01, 68084-976-33, 68084-976-32
Manufacturer
American Health Packaging
Effective date
2019-07-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Celecoxib - American Health PackagingAmerican Health Packaging2019-07-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-976-01EA - Each68084-976ea279450-3baa-42c3-a664-9b3a77d7b61812015-12-02
68084-976-11EA - Each68084-976f2d152d3-a6f6-415b-8880-96ef8f556e8512015-12-02
68084-976-32EA - Each68084-9766e4063c1-31b4-4a2e-a604-987a93020b5812015-03-03
68084-976-33EA - Each68084-976c99b302d-169e-4b8a-bf7b-4e247def2cbb12015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CELECOXIBACTIVE INGREDIENTJCX84Q7J1LCELECOXIB CAPSULE [AMERICAN HEALTH PACKAGING]2
CELECOXIBACTIVE MOIETYJCX84Q7J1LCELECOXIB CAPSULE [AMERICAN HEALTH PACKAGING]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LCELECOXIB CAPSULE [AMERICAN HEALTH PACKAGING]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCELECOXIB CAPSULE [AMERICAN HEALTH PACKAGING]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCELECOXIB CAPSULE [AMERICAN HEALTH PACKAGING]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CELECOXIB CAPSULE [AMERICAN HEALTH PACKAGING]2
GELATININACTIVE INGREDIENT2G86QN327LCELECOXIB CAPSULE [AMERICAN HEALTH PACKAGING]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ACELECOXIB CAPSULE [AMERICAN HEALTH PACKAGING]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ECELECOXIB CAPSULE [AMERICAN HEALTH PACKAGING]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CELECOXIB CAPSULE [AMERICAN HEALTH PACKAGING]2
SHELLACINACTIVE INGREDIENT46N107B71OCELECOXIB CAPSULE [AMERICAN HEALTH PACKAGING]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCELECOXIB CAPSULE [AMERICAN HEALTH PACKAGING]2
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UICELECOXIB CAPSULE [AMERICAN HEALTH PACKAGING]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCELECOXIB CAPSULE [AMERICAN HEALTH PACKAGING]2

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 110 of 114 · 2,280 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MannitolMANNITOLFresenius Kabi USA, LLCc395e13d-6ea1-4104-8b37-669cfb982f042023-03-16Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
CELECOXIBCELECOXIBA-S Medication Solutionsc7a183dc-f4d5-483f-964c-f2745a3640ad2023-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
Mineral Sunscreen SPF 50ZINC OXIDE TITANIUM DIOXIDETopiderm, Inc.3a637542-0f79-47ae-815d-84d0036c737a2023-02-13WarningsExact identifier
unii: 15FIX9V2JP
celecoxibCELECOXIBA-S Medication Solutions85bfe02b-bfcb-44ee-81a0-11765c3054a92023-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
Josie Maran Argan Daily Moisturizer SPF47ZINC OXIDE, TITANIUM DIOXIDEAutumn Harp, Inc.027821e6-db7d-4c03-956a-00313488ebc72023-01-14Boxed warning, WarningsExact identifier
unii: 15FIX9V2JP
Petrochemical DetoxCHELIDONIUM MAJUS, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, SYMPHYTUM OFFICINALE, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, CADMIUM SULPHURATUM, GELSEMIUM SEMPERVIRENS, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PLATINUM METALLICUM, LATRODECTUS MACTANSDeseret Biologicals, Inc.b38b492a-cf45-4aa2-ba7e-4573d2c4ebe52023-01-12WarningsExact identifier
unii: 6DC9Q167V3
unii: 368GB5141J
celecoxibCELECOXIBProficient Rx LP0ad14a4e-2f05-4ce7-93d1-1cb7e4d8f7d02022-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
AddiclenzBETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.e39235ea-2a2f-44a7-92d6-fb1d428ebabd2022-05-12WarningsExact identifier
unii: 15FIX9V2JP
celecoxibCELECOXIBProficient Rx LPcbd2d6de-6f0d-4b69-8e27-a1fe08830ba52022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBTianjin Tianyao Pharmaceuticals Co., Ltd.76f9bcb7-0e94-485f-816d-61d4e1ed24e02022-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Warm IvoryOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS97e7ece8-a705-4988-ba52-6d3f115735212021-12-01WarningsExact identifier
unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 ChestnutOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS6a44f926-11b4-4bc4-8d5d-721a89c4f0cc2021-11-09WarningsExact identifier
unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 HazelnutOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASb58af664-b0fd-4585-8417-7c20954d7aff2021-11-09WarningsExact identifier
unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 UmberOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS7bbd1334-fae8-4274-b927-a099af7643452021-11-09WarningsExact identifier
unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 CedarOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS970571f9-3d6b-46ae-a668-745de1911fa22021-11-09WarningsExact identifier
unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 WheatOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS542e1b2e-f63c-466b-b5ac-6c147a0e9dec2021-11-08WarningsExact identifier
unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Warm BeigeOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS21b65c12-6f67-4053-9508-6b2709cc1fb82021-11-08WarningsExact identifier
unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cool BeigeOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS8ea4c470-ebd5-448e-b72a-ccd1113de0ab2021-11-08WarningsExact identifier
unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 HoneyOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASfd9689a4-21d1-49f0-bf59-b8e1da72cd162021-11-08WarningsExact identifier
unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 DuneOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASc23b6a87-8cf9-4be3-8306-2285e7e926c12021-11-08WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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