Home NDC 43598-917 CARBOPROST TROMETHAMINE
Product NDC 43598-917
11-digit product format 435980917
Labeler code 43598
Product ID 43598-917_36c90ebd-a088-a3fb-a94b-6a602af0ddb3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name carboprost tromethamine
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR
Labeler Dr. Reddy�s Laboratories Inc.
Application ANDA211941
Marketing category ANDA
Marketing start 2020-02-04
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 A211941-001 CARBOPROST TROMETHAMINE CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2019-07-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211941-001 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.
Product history page 1 of 2 · 41 observed 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 A211941-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2019-07-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211941-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2019-07-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211941-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2019-07-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211941-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2019-07-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211941-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2019-07-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211941-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2019-07-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211941-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2019-07-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211941-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2019-07-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211941-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2019-07-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211941-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2019-07-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211941-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2019-07-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211941-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2019-07-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211941-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2019-07-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211941-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2019-07-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211941-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2019-07-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211941-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2019-07-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211941-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2019-07-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211941-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2019-07-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211941-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2019-07-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211941-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2019-07-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211941-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2019-07-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211941-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2019-07-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211941-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2019-07-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211941-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2019-07-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A211941-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2019-07-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A211941-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2019-07-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A211941-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2019-07-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211941-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2019-07-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211941-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2019-07-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211941-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2019-07-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211941-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2019-07-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211941-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2019-07-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211941-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2019-07-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211941-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2019-07-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211941-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2019-07-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211941-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2019-07-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211941-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2019-07-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211941-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2019-07-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211941-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2019-07-02 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211941-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2019-07-02 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2019-12-13 00:20 UTC 2019-12 A211941-001 CGT 2019-12-29 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 A211941-001 CGT 2019-12-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A211941-001 CGT 2019-12-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A211941-001 CGT 2019-12-29 ea99ee380514…
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 43598-917-11 CARBOPROST TROMETHAMINE 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 1 2 43598-917-58 CARBOPROST TROMETHAMINE 10 in 1 CARTON INJECTION, SOLUTION 10 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43598-917 CARBOPROST TROMETHAMINE INJECTION, SOLUTION [DR. REDDY’S LABORATORIES INC.] 2 Current NDC, Legacy NDC, 2 package rows 20241222_1fc164ae-9964-17b3-4b92-d25b0ddb805e.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 Marketing end Sample Exclude flag Status 43598-917-11 43598091711 1 mL in 1 VIAL, SINGLE-DOSE 1 ml Historical 43598-917-58 43598091758 10 VIAL, SINGLE-DOSE in 1 CARTON (43598-917-58) / 1 mL in 1 VIAL, SINGLE-DOSE (43598-917-11) 2020-02-04 0000-00-00 No No Current