FDA.reportPublic FDA data

Ketorolac Tromethamine

Product NDC
80425-0267
Requested package NDC
80425-0267-4
11-digit product format
804250267
Labeler code
80425
Product ID
80425-0267_2a9ad9e4-1654-c0dc-e063-6294a90a6e45
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA215788
Marketing category
ANDA
Marketing start
2023-02-17
Substance
KETOROLAC TROMETHAMINE
Active strength
10 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215788-001KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINE10MGTABLET / ORALAB2022-03-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A215788-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A215788-001KETOROLAC TROMETHAMINE10MGTABLET / ORALAB2022-03-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A215788-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ketorolac TromethamineKETOROLAC TROMETHAMINEAmerisyn LLC5734e81e-2471-1314-e063-6294a90ac9fe2026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215788
application number: ANDA215788
Ketorolac TromethamineKETOROLAC TROMETHAMINEMajor Pharmaceuticals48245718-a2df-4938-8d06-3b8abf34181e2026-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215788
application number: ANDA215788
Ketorolac TromethamineKETOROLAC TROMETHAMINENorthwind Health Company, LLC08674066-7d4b-936d-e063-6394a90abbd72026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215788
application number: ANDA215788
Ketorolac TromethamineKETOROLAC TROMETHAMINERedpharm Drug37453bcd-e34b-5902-e063-6294a90a02452025-12-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215788
application number: ANDA215788
ketorolac tromethamineKETOROLAC TROMETHAMINEAmici Pharma Inc.8b26240c-b72b-42a6-ab33-a1e38224fbe02025-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215788
application number: ANDA215788
Ketorolac TromethamineKETOROLAC TROMETHAMINEPreferred Pharmaceuticals Inc.18b450d2-e715-4710-a1d8-22b782f87f9c2025-09-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215788
application number: ANDA215788
Ketorolac TromethamineKETOROLAC TROMETHAMINEA-S Medication Solutions0952d430-2665-4952-ba06-ab99f054f4df2025-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215788
application number: ANDA215788
Ketorolac TromethamineKETOROLAC TROMETHAMINEBryant Ranch Prepackafc691f8-517a-4d88-8322-87dafec8f0642025-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215788
application number: ANDA215788
Ketorolac TromethamineKETOROLAC TROMETHAMINEGolden State Medical Supply, Inc.ec6d453b-4b84-53d4-e053-2995a90a60062025-02-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215788
application number: ANDA215788
Ketorolac TromethamineKETOROLAC TROMETHAMINEAjanta Pharma USA Inc.36713fb3-d301-432d-a95d-06e368fc8a222025-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215788
application number: ANDA215788
Ketorolac TromethamineKETOROLAC TROMETHAMINEAdvanced Rx Pharmacy of Tennessee, LLCf4e7f1c8-e458-0860-e053-2a95a90a1bf02024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215788
application number: ANDA215788
ndc (package): 80425-0267-4
ndc (product): 80425-0267
ndc11 (package): 80425026704
Ketorolac TromethamineKETOROLAC TROMETHAMINEA-S Medication Solutions6fa20b41-f860-4fea-b1fb-ab6d3fa34a902024-11-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215788
application number: ANDA215788
Ketorolac TromethamineKETOROLAC TROMETHAMINEDR. REDDY'S LABORATORIES, INC.10827042-a2d4-44f9-837d-2023a3d552ff2024-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215788
application number: ANDA215788
Ketorolac TromethamineKETOROLAC TROMETHAMINEBryant Ranch Prepack9e5fde54-2206-4072-afb8-4d06a8d314b12023-11-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215788
application number: ANDA215788

Additional Listing Data#

Finished product
Yes
Brand name base
Ketorolac Tromethamine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETOROLAC TROMETHAMINE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4EVE5946BQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
834022Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f4e7f1c8-e458-0860-e053-2a95a90a1bf0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6a38bd75-79e3-96c0-1204-08a0282902aeProduct name420250128
4d6e22a5-3693-6edf-0179-2ab93aecbadbProduct name920240724
03452e68-2506-686e-a908-f2381c778fc6Product name520240307
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
bb41bc3a-c643-93c9-055f-a8f48f363af3Product name220190219
4f6a8082-ae1e-0ff7-4dc0-77f9f0f7b70cProduct name120140508
8d3e992f-8ff7-c106-f7eb-1e2d5eb12025Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0267-1Ketorolac Tromethamine9 in 1 BOTTLETABLET, FILM COATED93
80425-0267-2Ketorolac Tromethamine20 in 1 BOTTLETABLET, FILM COATED203
80425-0267-3Ketorolac Tromethamine30 in 1 BOTTLETABLET, FILM COATED303
80425-0267-4Ketorolac Tromethamine60 in 1 BOTTLETABLET, FILM COATED603
80425-0267-5Ketorolac Tromethamine10 in 1 BOTTLETABLET, FILM COATED103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0267-1EA - Each80425-02677f333244-4aa6-487e-9bfa-3c425d655b2f12023-04-07
80425-0267-2EA - Each80425-026744667709-05c6-4da2-bdda-fffbed00dfa112023-04-07
80425-0267-3EA - Each80425-02670b79c085-7336-4a3b-aecf-f92f2256cbd012023-04-07
80425-0267-4EA - Each80425-026789140c3e-8295-4419-960c-9f33244ecd3f12023-04-07
80425-0267-5EA - Each80425-026758a927a8-9ee5-408c-aa6c-a943444b53e512023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0267KETOROLAC TROMETHAMINE TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]3Current NDC, 5 package rows20250102_f4e7f1c8-e458-0860-e053-2a95a90a1bf0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834022ketorolac tromethamine 10 MG Oral TabletPSNf4e7f1c8-e458-0860-e053-2a95a90a1bf03
834022ketorolac tromethamine 10 MG Oral TabletSCDf4e7f1c8-e458-0860-e053-2a95a90a1bf03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0267-48042502670460 TABLET, FILM COATED in 1 BOTTLE (80425-0267-4) 2023-02-17NoNoCurrent