Home NDC 69784-240 CARBOPROST TROMETHAMINE
Product NDC 69784-240
11-digit product format 697840240
Labeler code 69784
Product ID 69784-240_df5956f6-cd2e-20e0-e053-2995a90a419e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name carboprost tromethamine
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR
Labeler Woodward Pharma Services LLC
Application ANDA213118
Marketing category ANDA
Marketing start 2021-03-15
Marketing end 0000-00-00
Substance CARBOPROST TROMETHAMINE
Active strength 250 ug/mL
Pharmacologic classes Prostaglandin Analog [EPC], Prostaglandins [CS]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 69784-240 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 69784-240 69784-240-01 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 69784-240 69784-240-10 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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 A213118-001 CARBOPROST TROMETHAMINE CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2021-03-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213118-001 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 A213118-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2021-03-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213118-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2021-03-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213118-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2021-03-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213118-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2021-03-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213118-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2021-03-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213118-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2021-03-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213118-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2021-03-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213118-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2021-03-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213118-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2021-03-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213118-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2021-03-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213118-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2021-03-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213118-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2021-03-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213118-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2021-03-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213118-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2021-03-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213118-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2021-03-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213118-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2021-03-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213118-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2021-03-25 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213118-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2021-03-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213118-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2021-03-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213118-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2021-03-25 87673890dc5c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213118-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2021-03-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213118-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2021-03-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213118-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2021-03-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213118-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2021-03-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213118-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2021-03-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213118-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2021-03-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213118-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2021-03-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213118-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2021-03-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213118-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2021-03-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213118-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2021-03-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213118-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2021-03-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213118-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2021-03-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213118-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2021-03-25 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213118-001 CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE / INJECTION AP 2021-03-25 a50c72e98297…
Observed Orange Book normalized TE history# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69784-240 CARBOPROST TROMETHAMINE INJECTION, SOLUTION [WOODWARD PHARMA SERVICES LLC] 4 Legacy NDC 20230412_1dfd7cfe-2f6d-45e6-bf42-dc44fa8d1fd9.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69784-240-01 69784024001 1 mL in 1 AMPULE (69784-240-01) 1 ml 2021-03-15 0000-00-00 No No Current 69784-240-10 69784024010 10 AMPULE in 1 CARTON (69784-240-10) > 1 mL in 1 AMPULE (69784-240-01) 10 ampule 2021-03-15 0000-00-00 No No Current