FDA.reportPublic FDA data

NDC 63629-2974-01 - Ketorolac Tromethamine

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
63629-2974
Requested NDC
63629-2974-01
Package NDCs from labels
63629-2974-1, 63629-2974-2, 63629-2974-3, 63629-2974-4, 63629-2974-5, 63629-2974-6, 63629-2974-7, 63629-2974-8, 63629-2974-9, 63629-2974-0, 63629-2974-01
Manufacturer
Bryant Ranch Prepack
Effective date
2023-11-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ketorolac Tromethamine - Bryant Ranch PrepackBryant Ranch Prepack2023-11-28HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63629-2974-02020-02-25Ketorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-12020-02-25Ketorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-22020-02-25Ketorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-32020-02-25Ketorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-42020-02-25Ketorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-52020-02-25Ketorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-62020-02-25Ketorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-72020-02-25Ketorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-82020-02-25Ketorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-92020-02-25Ketorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-02020-01-31Ketorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-12020-01-31Ketorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-22020-01-31Ketorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-32020-01-31Ketorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-42020-01-31Ketorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-52020-01-31Ketorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-62020-01-31Ketorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-72020-01-31Ketorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-82020-01-31Ketorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-92020-01-31Ketorolac Tromethamine Tablets USP, 10 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-2974-0Ketorolac Tromethamine3 in 1 BOTTLETABLET, FILM COATED39
63629-2974-1Ketorolac Tromethamine30 in 1 BOTTLETABLET, FILM COATED309
63629-2974-2Ketorolac Tromethamine10 in 1 BOTTLETABLET, FILM COATED109
63629-2974-3Ketorolac Tromethamine20 in 1 BOTTLETABLET, FILM COATED209
63629-2974-4Ketorolac Tromethamine90 in 1 BOTTLETABLET, FILM COATED909
63629-2974-5Ketorolac Tromethamine16 in 1 BOTTLETABLET, FILM COATED169
63629-2974-6Ketorolac Tromethamine8 in 1 BOTTLETABLET, FILM COATED89
63629-2974-7Ketorolac Tromethamine15 in 1 BOTTLETABLET, FILM COATED159
63629-2974-8Ketorolac Tromethamine5 in 1 BOTTLETABLET, FILM COATED59
63629-2974-9Ketorolac Tromethamine100 in 1 BOTTLETABLET, FILM COATED1009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2974KETOROLAC TROMETHAMINE TABLET, FILM COATED [BRYANT RANCH PREPACK]9Current NDC, Legacy NDC, 10 package rows20231129_f713500a-20b8-8e20-c4cc-956805170335.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2974-1EA - Each63629-29746397c33a-5a04-4871-be93-21b6c5a053fa12012-07-24
63629-2974-2EA - Each63629-29742cd49b80-261e-4664-89ee-f858377795c412012-07-24
63629-2974-3EA - Each63629-2974216e37ae-185a-46a9-8a0d-4a771cabef6712012-07-24
63629-2974-4EA - Each63629-2974344b0a89-4921-4423-af5b-e02367b8a89c12012-07-24
63629-2974-5EA - Each63629-2974567ce373-8e35-4c37-b0bb-9d25adcd444712012-07-24
63629-2974-6EA - Each63629-2974cbb255f1-f663-4a34-90c7-4e042526b0b012012-07-24
63629-2974-7EA - Each63629-29740f42e9c0-81ce-4017-9416-058cc29bb85712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
KETOROLAC TROMETHAMINEACTIVE INGREDIENT4EVE5946BQKETOROLAC TROMETHAMINE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
KETOROLACACTIVE MOIETYYZI5105V0LKETOROLAC TROMETHAMINE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UKETOROLAC TROMETHAMINE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PKETOROLAC TROMETHAMINE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOKETOROLAC TROMETHAMINE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XKETOROLAC TROMETHAMINE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30KETOROLAC TROMETHAMINE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AKETOROLAC TROMETHAMINE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPKETOROLAC TROMETHAMINE TABLET, FILM COATED [BRYANT RANCH PREPACK]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 5 of 114 · 2,273 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunbetter Daily Mineral Protection Broad Spectrum SPF 70 Sheer SunscreenTITANIUM DIOXIDE AND ZINC OXIDESKINBETTER SCIENCE LLC5410e0ed-aed5-3279-e063-6294a90a0c3e2026-06-12WarningsExact identifier
unii: 15FIX9V2JP
Visine Red Eye Total Comfort Multi-SymptomTETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, AND ZINC SULFATE, UNSPECIFIED FORMKenvue Brands LLC5747edef-7a87-41d7-9594-6c78508b9ba22026-06-11WarningsExact identifier
unii: B697894SGQ
it cosmetics Your Skin But Better CC Plus Natural Matte Color Correcting Pore Refining Full Coverage Skin Balancing Serum Broad Spectrum SPF 40 SunscreenENSULIZOLE, OCTISALATE AND TITANIUM DIOXIDEIT COSMETICS, LLCf2990320-b61d-40b8-ba79-18d6b37e7f522026-06-11WarningsExact identifier
unii: 15FIX9V2JP
ketorolac tromethamineKETOROLAC TROMETHAMINEPreferred Pharmaceuticals Inc.1e7ae5af-76b9-49a9-ba14-52b566929c222026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 834022
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINERedpharm Drug53cb9528-7640-1fd4-e063-6294a90a74ad2026-06-09Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
RE-NUTRIV AGE REVERSAL VITAL RADIANCE SERUM FOUNDATION SPF 20OCTINOXATE AND TITANIUM DIOXIDEESTEE LAUDER INC53d76b02-442e-7a5d-e063-6394a90ae1b32026-06-09WarningsExact identifier
unii: 15FIX9V2JP
FUTURIST HYDRATING COLLAGEN-PEPTIDE MAKEUP BROAD SPECTRUM SPF 20OCTINOXATE AND TITANIUM DIOXIDEESTEE LAUDER INC53d9d689-4a86-5b9c-e063-6394a90aef182026-06-09WarningsExact identifier
unii: 15FIX9V2JP
Eryfotona Ageless Tinted Lightweight Emulsion SunscreenTITANIUM DIOXIDEISDIN Corp.293a1116-e8a2-495f-83db-20dd82ed13c22026-06-08WarningsExact identifier
unii: 15FIX9V2JP
Eryfotona Actinica TintedTITANIUM DIOXIDEISDIN Corp.97357703-0e93-4216-bd1b-a9b2027819592026-06-05WarningsExact identifier
unii: 15FIX9V2JP
ketorolac tromethamineKETOROLAC TROMETHAMINEREMEDYREPACK INC.26a1761b-90bf-49c6-9e6a-f293af2296ce2026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Mineral Mattescreen SPF 40 - UntintedTITANIUM DIOXIDE, ZINC OXIDESupergoop, LLC08671d39-3be2-d666-e063-6294a90a62072026-06-04WarningsExact identifier
unii: 15FIX9V2JP
Mineral Mattescreen SPF 40 - Golden HourTITANIUM DIOXIDE, ZINC OXIDESupergoop, LLCc2398820-f003-707f-e053-2a95a90a69292026-06-04WarningsExact identifier
unii: 15FIX9V2JP
Epionce Daily Shield Tinted SPF 50TITANIUM DIOXIDE, ZINC OXIDEEpisciences, Inc.3d1e2921-cba9-4446-e054-00144ff8d46c2026-06-04WarningsExact identifier
unii: 15FIX9V2JP
VitaPhyte Redness Reliever Lubricant Eye DropsREDNESS RELIEVER LUBRICANT EYE DROPSGuangzhou Liyan Cosmetics Technology Co., Ltd.53d4e9b0-c9a0-797a-e063-6294a90ad0cf2026-06-04WarningsExact identifier
unii: B697894SGQ
Ketorolac TromethamineKETOROLAC TROMETHAMINECardinal Health 107, LLCf335a030-ffa8-4f42-8166-2f06e036b40d2026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
ANESSA PERFECT UV SUNSCREEN SKINCARE MILK GBZINC OXIDE OCTOCRYLENE ETHYLHEXYL SALICYLATE HOMOSALATE TITANIUM DIOXIDEHONGKONG JIAHE INTERNATIONAL HOLDING LIMITED5354af18-50c4-5fba-e063-6394a90ace392026-06-03WarningsExact identifier
unii: 15FIX9V2JP
ATOMY BB SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.b0cd27ee-4917-4800-bcdf-c6e14b28c1d12026-06-02WarningsExact identifier
unii: 15FIX9V2JP
Atomy Sunscreen White Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.ad0b9091-a990-45bf-93f4-d886be1bbffe2026-06-02WarningsExact identifier
unii: 15FIX9V2JP
Atomy Sunscreen Beige Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.994d5680-284e-4faf-a29b-4d28f8d46e8f2026-06-02WarningsExact identifier
unii: 15FIX9V2JP
Matte Veil Tinted Broad Spectrum Sunscreen SPF 40ZINC OXIDE, TITANIUM DIOXIDEPrivate Label Skin Carea8d60212-18a7-42af-8bb3-bfcff7690a492026-06-02WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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