Home NDC 65219-579 CARBOPROST TROMETHAMINE
Product NDC 65219-579
11-digit product format 652190579
Labeler code 65219
Product ID 65219-579_9388ae75-3bda-41ee-93b5-f99313a16391
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name carboprost tromethamine
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR
Labeler Fresenius Kabi USA, LLC
Application ANDA216882
Marketing category ANDA
Marketing start 2023-06-12
Substance CARBOPROST TROMETHAMINE
Active strength 250 ug/mL
Pharmacologic classes Prostaglandin Analog [EPC], Prostaglandins [CS]
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216882-001 CARBOPROST TROMETHAMINE CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2023-02-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216882-001 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 2026-02-19 14:30 UTC 2026-02 A216882-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2023-02-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216882-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2023-02-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216882-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2023-02-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216882-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2023-02-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216882-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2023-02-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216882-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2023-02-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216882-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2023-02-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216882-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2023-02-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216882-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2023-02-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216882-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2023-02-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216882-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2023-02-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216882-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2023-02-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216882-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2023-02-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216882-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2023-02-13 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216882-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2023-02-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216882-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2023-02-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216882-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2023-02-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216882-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2023-02-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216882-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2023-02-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216882-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2023-02-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216882-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2023-02-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A216882-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2023-02-13 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216882-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2023-02-13 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base CARBOPROST TROMETHAMINE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CARBOPROST TROMETHAMINE 250 ug/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U4526F86FJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 238014 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 65219-579-00 CARBOPROST TROMETHAMINE 1 mL in 1 VIAL INJECTION, SOLUTION 1 1 65219-579-01 CARBOPROST TROMETHAMINE 10 in 1 CARTON INJECTION, SOLUTION 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65219-579 CARBOPROST TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 1 Current NDC, 2 package rows 20230613_e5f58209-bc3d-4d9f-a372-bc14f877d16c.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 · 3 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 65219-579-00 65219057900 1 mL in 1 VIAL 1 ml Historical 65219-579-01 65219057901 10 VIAL in 1 CARTON (65219-579-01) / 1 mL in 1 VIAL (65219-579-00) 10 vial 2023-06-12 No No Current