FDA.reportPublic FDA data

NDC 63629-2974-09 - 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
63629-2974-09
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, 63629-2974-09
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 1 of 115 · 2,285 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Dr.Harry EYES PROTECTIONPOLYETHYLENE GLYCOL 400 1% EYES PROTECTIONWenzhou Yuyuan Pharmaceutical Co., Ltd.5a9fe033-89d3-da62-e063-6294a90a45032026-09-03WarningsExact identifier
unii: B697894SGQ
ketorolac tromethamineKETOROLAC TROMETHAMINESportpharm LLC2a23b0fa-803c-4abb-b588-12cfe83326a92026-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINEREMEDYREPACK INC.6f727e1f-2838-427b-a236-eeb0101b08f32026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEREMEDYREPACK INC.cdd4d548-33f8-42d6-8eae-e36aa577c0502026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINEREMEDYREPACK INC.04d5114e-332b-4ed0-85df-b276c1dc296c2026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 834022
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINECardinal Health 107, LLC6758cb38-dec8-468f-94e2-613772e39b9a2026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
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
Ketorolac TromethamineKETOROLAC TROMETHAMINERedpharm Drug59d86768-6214-8389-e063-6394a90a0a3d2026-08-25Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
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
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEHF Acquisition Co LLC, DBA HealthFirst54dec321-b4c9-f0d6-e063-6294a90ae2312026-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Ketorolac TromethamineKETOROLAC TROMETHAMINESportpharm LLC0749f61d-12e6-4280-8f41-bd4df81e7ae62026-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA074754
rxcui: 834022
unii: 4EVE5946BQ
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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