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 71 of 116 · 2,307 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Impact Melanoma SPF 30ZINC OXIDERENU LABORATORIES, LLCf953302e-f712-129a-e053-6294a90ab9a82025-03-13WarningsExact identifier
unii: 15FIX9V2JP
Vertra Ehukai Beige Sunscreen Face Stick Broad Spectrum SPF 38TITANIUM DIOXIDEEai-jr 286, Inc303d5d5a-4c7a-1e23-e063-6294a90a0e582025-03-13WarningsExact identifier
unii: 15FIX9V2JP
CELECOXIBCELECOXIBQuallent Pharmaceuticals Health LLCaaa3a4f5-b281-415f-a08c-e0cefdae2fb52025-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CELECOXIBCELECOXIBCipla USA Inc.d12625b1-2af9-4532-af91-d40b65eeffef2025-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CELECOXIBCELECOXIBNorthStar RxLLCce61a585-5ac0-4185-99eb-a9511cd25a982025-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
AddiclenzASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, BETA VULGARIS, BISPHENOL A, BOLDO, CHELIDONIUM MAJUS, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, TARAXACUM OFFICINALE, ZINCUM METALLICUMDeseret Biologicals, Inc.25036c26-1c21-4e5a-b4db-b8e1774583412025-03-11WarningsExact identifier
unii: 15FIX9V2JP
Bestmade Natural Products BM235ACONITE, CACTUS, CRATAEGUS, ALFALFA, CHIONANTHUS, P. GLYCOLBestmade Natural Products2f82818a-fc34-75e5-e063-6394a90a03012025-03-04WarningsExact identifier
unii: 6DC9Q167V3
MINERAL TINTED SPF 30TITANIUM DIOXIDE, ZINC OXIDEBOTANICAL SCIENCE, INC.2f9e2252-fb54-363f-e063-6294a90aa7c92025-03-04WarningsExact identifier
unii: 15FIX9V2JP
CoTZ Kids Mineral Sun StickTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD2f7225d0-ddfa-e19a-e063-6294a90a52a82025-03-03WarningsExact identifier
unii: 15FIX9V2JP
Sun Defense Minerals (Fair)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e21c9f9-acf8-997b-e063-6394a90ada3f2025-03-01WarningsExact identifier
unii: 15FIX9V2JP
Sun Defense Minerals (Medium)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e232e8d-4274-68bc-e063-6394a90a942b2025-03-01WarningsExact identifier
unii: 15FIX9V2JP
HA Physical Tint SPF 44ZINC OXIDE, TITANIUM DIOXIDEPrivate Label Skin Carea5e19d77-703e-41e0-9a02-19227dc6c8192025-02-27WarningsExact identifier
unii: 15FIX9V2JP
BRUSH ON BLOCK SPF 50 MINERAL TRANSLUCENT ZINC ONLY REFILLZINC OXIDE/TITANIUM DIOXIDESPF Ventures, LLC2f069114-9ca8-aed4-e063-6394a90a46d82025-02-26WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Cream230 NMelaleuca Inc.2f133abb-cad2-2ac8-e063-6294a90aa4802025-02-26WarningsExact identifier
unii: 15FIX9V2JP
Sun Defense Minerals (Tan)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2efb73a6-601d-61a4-e063-6294a90af8252025-02-25WarningsExact identifier
unii: 15FIX9V2JP
Sun Defense Minerals (Tan)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2ee82379-6609-fd8e-e063-6294a90acf6c2025-02-24WarningsExact identifier
unii: 15FIX9V2JP
REPAIRWEAR UPLIFTING FIRMING BROAD SPECTUM SPF 15 - NORMAL COMBO TO COMBINATION oilyOCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDECLINIQUE LABORATORIES LLC10edc0c1-9359-4c7a-a56e-bad06fea00562025-02-20WarningsExact identifier
unii: 15FIX9V2JP
celecoxibCELECOXIBBryant Ranch Prepackac5c0d72-1bb3-4065-b2f4-5516b08697752025-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBNCS HealthCare of KY, LLC dba Vangard Labs34bef49c-eca1-4f17-9b1b-55900ac408292025-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
FEELSHION Glycolic Acid Exfoliating Face PadsPROPYLENE GLYCOL,ARGININE,LACTIC ACID,SALICYLIC ACID,GLYCOLIC ACIDBeijing JUNGE Technology Co., Ltd.2e79678c-1ce4-25cf-e063-6394a90a133c2025-02-19WarningsExact identifier
unii: 6DC9Q167V3

Reported adverse events (FAERS/openFDA)#

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