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 3 of 114 · 2,273 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ketorolac TromethamineKETOROLAC TROMETHAMINEApotex Corp.d9a186ba-74a9-b6d4-1109-1e045ba1763e2026-07-16Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEHF Acquisition Co LLC, DBA HealthFirste46ebc7f-584e-e2b7-e053-2995a90ad17b2026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DERMIO DERMATOLOGY LLC562f5b0d-6a10-305d-e063-6394a90a59802026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30Suzanne's Skin2soul LLC562fbaa6-f93a-5ec4-e063-6294a90a96342026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Aussie Betta Tallow Sunscreen SPF50 SPF50TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENAUSSIE BETTA HEALTHY CARE PTY LTD56007d82-ff5b-6c26-e063-6294a90a09b62026-07-07WarningsExact identifier
unii: 15FIX9V2JP
EELHOE Body Coverage PerfectorTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5610c3b7-456b-3bc1-e063-6394a90a3fa82026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Emerald Aesthetics LLC55f88dd1-346c-22a5-e063-6294a90a711f2026-07-06WarningsExact identifier
unii: 15FIX9V2JP
OHUI Ultimate Cover CC Cushion Compact 02 Natural BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d307471c-6cc6-ce48-e053-2995a90a3e022026-07-02WarningsExact identifier
unii: 15FIX9V2JP
Evereden Fluid Silk Mineral Sunscreen PRO SPF50TITANIUM DIOXIDE, ZINC OXIDEEden Brands Inc.2cb7773f-9a05-ad02-e063-6294a90af0242026-07-01WarningsExact identifier
unii: 15FIX9V2JP
Ketorolac TromethamineKETOROLAC TROMETHAMINESt. Mary's Medical Park Pharmacy2d552135-bde5-5fe9-e063-6394a90af4332026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 834022
unii: 4EVE5946BQ
OHUI Ultimate Cover CC Cushion Compact 01 Light BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d2f9c54b-ac4e-5141-e053-2a95a90aa2b82026-06-30WarningsExact identifier
unii: 15FIX9V2JP
TOCOBO Blur Finish Sun Cushion Cotton BlueHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEPICTON Co., Ltd.4d6ddee3-9a76-6c9c-e063-6394a90a15292026-06-29WarningsExact identifier
unii: 15FIX9V2JP
Earth Baby Broad Spectrum SPF 30SUNSCREENEarth Baby, Inc.42556876-74ea-38e6-e054-00144ff8d46c2026-06-28WarningsExact identifier
unii: 15FIX9V2JP
Sun Does Matter Daily Face SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDESundoesmatter Company Inc.553687d8-d4e1-8361-e063-6294a90a24fe2026-06-27WarningsExact identifier
unii: 15FIX9V2JP
Ivory Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f25ba-61d5-6a94-e063-6394a90a46e92026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Simply Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f4799-9122-8db5-e063-6394a90a51322026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Vanilla Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f6d2c-9b8c-aa52-e063-6294a90a787e2026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Coral Isle SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERocky Mountain5515f562-62d9-c6ee-e063-6294a90a9ea62026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Delicate Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551928b4-74bb-3f6c-e063-6294a90a6b832026-06-25WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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