Home NDC 0264-8031 TROMETHAMINE
Product NDC 0264-8031
11-digit product format 002648031
Labeler code 0264
Product ID 0264-8031_87d30389-4483-4d62-a623-d4676e7d16c9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TROMETHAMINE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler B. Braun Medical Inc.
Application ANDA211558
Marketing category ANDA
Marketing start 2025-08-27
Substance TROMETHAMINE
Active strength 3.6 g/100mL
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 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211558-001 TROMETHAMINE TROMETHAMINE 18GM/500ML (3.6GM/100ML) SOLUTION / INJECTION AP 2024-12-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211558-001 AP
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 2026-08-18 06:07:40 2026-07 A211558-001 TROMETHAMINE 18GM/500ML (3.6GM/100ML) SOLUTION / INJECTION AP 2024-12-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211558-001 TROMETHAMINE 18GM/500ML (3.6GM/100ML) SOLUTION / INJECTION AP 2024-12-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211558-001 TROMETHAMINE 18GM/500ML (3.6GM/100ML) SOLUTION / INJECTION AP 2024-12-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211558-001 TROMETHAMINE 18GM/500ML (3.6GM/100ML) SOLUTION / INJECTION AP 2024-12-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211558-001 TROMETHAMINE 18GM/500ML (3.6GM/100ML) SOLUTION / INJECTION AP 2024-12-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211558-001 TROMETHAMINE 18GM/500ML (3.6GM/100ML) SOLUTION / INJECTION AP 2024-12-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211558-001 TROMETHAMINE 18GM/500ML (3.6GM/100ML) SOLUTION / INJECTION AP 2024-12-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211558-001 TROMETHAMINE 18GM/500ML (3.6GM/100ML) SOLUTION / INJECTION AP 2024-12-09 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211558-001 TROMETHAMINE 18GM/500ML (3.6GM/100ML) SOLUTION / INJECTION AP 2024-12-09 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base TROMETHAMINE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TROMETHAMINE 3.6 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 023C2WHX2V Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198412 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 0264-8031-10 TROMETHAMINE 500 mL in 1 BAG INJECTION, SOLUTION 500 7 0264-8031-10 TROMETHAMINE 24 in 1 CASE INJECTION, SOLUTION 24 7
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 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0264-8031-10 00264803110 24 BAG in 1 CASE (0264-8031-10) / 500 mL in 1 BAG 24 bag 2025-08-27 No No Current