Home NDC 71357-001 Tromethamine
Product NDC 71357-001
11-digit product format 713570001
Labeler code 71357
Product ID 71357-001_47d8e7ea-786a-263c-e063-6394a90a6a18
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tromethamine
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler MILLA PHARMACEUTICALS INC.
Application ANDA213116
Marketing category ANDA
Marketing start 2024-12-31
Substance TROMETHAMINE
Active strength 3.6 g/100mL
NDC exclude flag No
Listing certified through 2027-12-31
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 A213116-001 TROMETHAMINE TROMETHAMINE 18GM/500ML (3.6GM/100ML) SOLUTION / INJECTION AP 2024-12-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213116-001 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 A213116-001 TROMETHAMINE 18GM/500ML (3.6GM/100ML) SOLUTION / INJECTION AP 2024-12-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213116-001 TROMETHAMINE 18GM/500ML (3.6GM/100ML) SOLUTION / INJECTION AP 2024-12-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213116-001 TROMETHAMINE 18GM/500ML (3.6GM/100ML) SOLUTION / INJECTION AP 2024-12-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213116-001 TROMETHAMINE 18GM/500ML (3.6GM/100ML) SOLUTION / INJECTION AP 2024-12-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213116-001 TROMETHAMINE 18GM/500ML (3.6GM/100ML) SOLUTION / INJECTION AP 2024-12-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213116-001 TROMETHAMINE 18GM/500ML (3.6GM/100ML) SOLUTION / INJECTION AP 2024-12-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213116-001 TROMETHAMINE 18GM/500ML (3.6GM/100ML) SOLUTION / INJECTION AP 2024-12-31 03ed91905a0d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213116-001 TROMETHAMINE 18GM/500ML (3.6GM/100ML) SOLUTION / INJECTION AP 2024-12-31 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213116-001 CGT 2025-07-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213116-001 CGT 2025-07-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213116-001 CGT 2025-07-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213116-001 CGT 2025-07-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213116-001 CGT 2025-07-01 03ed91905a0d…
Additional Listing Data#
Finished product Yes
Brand name base Tromethamine
Listing expiration 2027-12-31 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 71357-001-01 Tromethamine 6 in 1 CASE INJECTION, SOLUTION 6 3 71357-001-06 Tromethamine 500 mL in 1 BOTTLE, GLASS INJECTION, SOLUTION 500 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71357-001 TROMETHAMINE INJECTION, SOLUTION [MILLA PHARMACEUTICALS INC.] 2 Current NDC, 2 package rows 20250101_082b1104-502b-47af-95bf-0dbf2422990e.zip
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 71357-001-01 71357000101 6 BOTTLE, GLASS in 1 CASE (71357-001-01) / 500 mL in 1 BOTTLE, GLASS (71357-001-06) 2024-12-31 No No Current 71357-001-06 71357000106 500 mL in 1 BOTTLE, GLASS 500 ml Historical