Carboprost Tromethamine

Product NDC: 72485-525
11-digit product format: 724850525
Labeler code: 72485
Product ID: 72485-525_9992b58a-16fa-40d8-800a-f20f839a8aba
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carboprost Tromethamine
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR
Labeler: Armas Pharmaceuticals Inc.
Application: ANDA216882
Marketing category: ANDA
Marketing start: 2026-09-15
Substance: CARBOPROST TROMETHAMINE
Active strength: 250 ug/mL
Pharmacologic classes: Prostaglandin Analog [EPC], Prostaglandins [CS]
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 43.

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A216882-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-02-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216882-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-02-13	`caaa826d4ba7…`
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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A216882-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216882-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216882-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216882-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216882-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216882-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216882-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216882-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216882-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216882-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216882-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216882-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216882-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216882-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216882-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216882-001	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216882-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216882-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216882-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216882-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216882-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216882-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216882-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216882-001	AP	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216882-001	AP	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Carboprost Tromethamine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CARBOPROST TROMETHAMINE	250 ug/mL

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CARBOPROST TROMETHAMINE	CARBOPROST TROMETHAMINE	Caplin Steriles Limited	42736d6a-0ab3-4c3c-897d-406aad5a49c2	2025-01-20	Adverse reactions	Exact identifier application applno (ANDA): 216882 application number: ANDA216882
CARBOPROST TROMETHAMINE	CARBOPROST TROMETHAMINE	BE Pharmaceuticals Inc.	8447d4f1-d286-4aa0-a379-a673518da045	2023-05-09	Adverse reactions	Exact identifier application applno (ANDA): 216882 application number: ANDA216882
CARBOPROST TROMETHAMINE	CARBOPROST TROMETHAMINE	Fresenius Kabi USA, LLC	e5f58209-bc3d-4d9f-a372-bc14f877d16c	2023-05-05	Adverse reactions	Exact identifier application applno (ANDA): 216882 application number: ANDA216882

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U4526F86FJ	CARBOPROST TROMETHAMINE	58551-69-2	CARBOPROST TROMETHAMINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72485-525-10	72485052510	10 VIAL, SINGLE-DOSE in 1 CARTON (72485-525-10) / 1 mL in 1 VIAL, SINGLE-DOSE (72485-525-01)	2026-09-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carboprost Tromethamine Injection, USP	Armas Pharmaceuticals Inc.	2026-08-14	Human Prescription Drug Label	1