Home NDC 83270-157-01 KETOROLAC TROMETHAMINE
Product NDC 83270-157
Requested package NDC 83270-157-01
11-digit product format 832700157
Labeler code 83270
Product ID 83270-157_45964863-b614-400a-e063-6294a90ac151
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name KETOROLAC TROMETHAMINE
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Onesource Specialty Pharma Limited
Application ANDA201155
Marketing category ANDA
Marketing start 2023-09-30
Substance KETOROLAC TROMETHAMINE
Active strength 15 mg/mL
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A201155-001 KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2014-08-04 A201155-002 KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2014-08-04
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A201155-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION 2014-08-04 a50c72e98297…2026-08-01 22:54:32 2026-06 A201155-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION 2014-08-04 a50c72e98297…
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 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base KETOROLAC TROMETHAMINE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength KETOROLAC TROMETHAMINE 15 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4EVE5946BQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 860113 Internal RxNorm lookup 860114 Internal RxNorm lookup 860115 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83270-157-01 KETOROLAC TROMETHAMINE 1 in 1 CARTON INJECTION 1 1 83270-157-01 KETOROLAC TROMETHAMINE 1 mL in 1 SYRINGE, GLASS INJECTION 1 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 83270-157-01 83270015701 1 SYRINGE, GLASS in 1 CARTON (83270-157-01) / 1 mL in 1 SYRINGE, GLASS 2023-09-30 No No Current