FDA.reportPublic FDA data

NDC 68084-976-11 - 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
68084-976-11
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 82 of 114 · 2,280 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ERBORIAN - BB CREME AU GINSENG CLAIR SPF 20OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&Lee9ae84b-c8fc-4a87-8910-46ec8ccfe1a92024-12-11WarningsExact identifier
unii: 15FIX9V2JP
ERBORIAN - BB CREME AU GINSENG DORE SPF 20OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L121aa873-5ca6-426b-8ece-dcb5a9f82a032024-12-11WarningsExact identifier
unii: 15FIX9V2JP
ERBORIAN - CC CREME HIGH DEFINITION SPF 25OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L3421b9a3-6551-406f-af3a-b3da8a01d2b22024-12-11WarningsExact identifier
unii: 15FIX9V2JP
ERBORIAN CC RED CORRECT SPF 25OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELaboratoires M&L21530925-03b7-40bb-9836-6ee4011c4a792024-12-11WarningsExact identifier
unii: 15FIX9V2JP
ERBORIAN CC CREME HIGH DEFINITION SPF 25 CARAMELOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L70a5537c-a364-4dae-8ab2-8ca0cbfd11b72024-12-11WarningsExact identifier
unii: 15FIX9V2JP
ERBORIAN - CC CREME HIGH DEFINITION SPF25 CLAIROCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&Lb55be8cb-7f21-45b0-bb8f-a60182077ca32024-12-11WarningsExact identifier
unii: 15FIX9V2JP
I Conceal Flawless Foundation Broad Spectrum SPF 30 Sunscreen Deep HoneyZINC OXIDE AND TITANIUM DIOXIDEAllure Labsdc792777-d8b6-3ebc-e053-2a95a90abc3f2024-12-11WarningsExact identifier
unii: 15FIX9V2JP
CelecoxibCELECOXIBBryant Ranch Prepack0d89c39e-4858-4255-9127-1366e005203c2024-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBBryant Ranch Prepack0dc9020d-28f5-4c69-896c-87b38e3ddb882024-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
Tinted Sunscreen Cream SPF 30 4-Deep AmberTITANIUM DIOXIDE, ZINC OXIDEC.F.E.B. - Sisley5599922a-b020-477c-a44c-1db42ec5756a2024-12-10WarningsExact identifier
unii: 15FIX9V2JP
Tinted Sunscreen SPF 30 1-NaturalTITANIUM DIOXIDE, ZINC OXIDEC.F.E.B. - Sisleyb3d53a10-2647-492a-a05f-b97c3f716aa82024-12-10WarningsExact identifier
unii: 15FIX9V2JP
Tinted Sunscreen SPF 30 2-GoldenTITANIUM DIOXIDE, ZINC OXIDEC.F.E.B. - Sisley389cbce6-552c-4633-babd-7b672632f0b92024-12-10WarningsExact identifier
unii: 15FIX9V2JP
Prevention Daily Tinted Moisturizer SPF 30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labsed883d63-777c-e924-e053-2995a90a162a2024-12-09WarningsExact identifier
unii: 15FIX9V2JP
I Conceal Flawless Foundation Broad Spectrum SPF 30 Sunscreen MahoganyZINC OXIDE AND TITANIUM DIOXIDEAllure Labsdcba05ff-7a68-c5c0-e053-2a95a90a61292024-12-09WarningsExact identifier
unii: 15FIX9V2JP
MD Restoring daily Defense Moisturizer SPF 50ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs Inceb8e7109-b5eb-5cc1-e053-2995a90a486f2024-12-09WarningsExact identifier
unii: 15FIX9V2JP
Quench and Protect Hydrating SPF30ZINC DIOXIDE AND TITANIUM DIOXIDEAllure Labs.039e50c1-7b3d-d392-e063-6394a90a4b3c2024-12-09WarningsExact identifier
unii: 15FIX9V2JP
Derm Institute Daily Defense Protection Sunscreen Broad Spectrum SPF50TITANIUM DIOXIDE, ZINC OXIDEBeautcella Inc.bad942d8-04da-31d2-e053-2a95a90a92752024-12-06WarningsExact identifier
unii: 15FIX9V2JP
MISSHA M Perfect Cover BB Cream SPF42 (No. 25)ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.604e7a49-7986-11ee-e053-2a91aa0a1bee2024-12-05WarningsExact identifier
unii: 15FIX9V2JP
MISSHA M Perfect Cover BB No 27ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.c4e16cec-c7db-4e5e-9d05-5d7afdb790912024-12-05WarningsExact identifier
unii: 15FIX9V2JP
MISSHA M Perfect Cover BB SPF42 No29OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDEAble C&C Co., Ltd.3fc90114-4cdf-273e-e054-00144ff8d46c2024-12-05WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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