carboprost tromethamine

Product NDC: 68083-584
11-digit product format: 680830584
Labeler code: 68083
Product ID: 68083-584_ed3dacb6-5a1e-4499-bec2-5ec46a0399ad
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: carboprost tromethamine
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR
Labeler: Gland Pharma Limited
Application: ANDA217657
Marketing category: ANDA
Marketing start: 2023-08-07
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
A217657-001	CARBOPROST TROMETHAMINE	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP		2023-08-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A217657-001	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
2026-02-19 14:30 UTC	2026-02	A217657-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-08-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217657-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-08-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217657-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-08-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217657-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-08-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217657-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-08-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217657-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-08-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217657-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-08-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217657-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-08-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217657-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-08-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217657-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-08-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217657-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-08-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217657-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-08-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217657-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-08-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217657-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-08-07	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217657-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-08-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217657-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-08-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217657-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-08-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217657-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-08-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217657-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-08-07	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217657-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-08-07	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A217657-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217657-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217657-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217657-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217657-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217657-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217657-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217657-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217657-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217657-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217657-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217657-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217657-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217657-001	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217657-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217657-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217657-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217657-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217657-001	AP	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217657-001	AP	1	`a50c72e98297…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5902edd8-16b3-4f52-ac35-b0f4dfb5ab6a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75	Product name	2	20250814
bf7dbc85-c3be-ce3e-e49f-8b9d8ea1ff7c	Product name	5	20240515

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68083-584-10	carboprost tromethamine	1 mL in 1 VIAL	INJECTION, SOLUTION	1		2
68083-584-10	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
68083-584	CARBOPROST TROMETHAMINE INJECTION, SOLUTION [GLAND PHARMA LIMITED]	2	Current NDC, 2 package rows	20230809_5902edd8-16b3-4f52-ac35-b0f4dfb5ab6a.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
carboprost tromethamine	CARBOPROST TROMETHAMINE	Hospira, Inc.	e5054c6a-c54e-4ddf-8280-a154b90cac07	2024-04-15	Adverse reactions	Exact identifier application applno (ANDA): 217657 application number: ANDA217657
carboprost tromethamine	CARBOPROST TROMETHAMINE	Gland Pharma Limited	5902edd8-16b3-4f52-ac35-b0f4dfb5ab6a	2023-08-08	Adverse reactions	Exact identifier application applno (ANDA): 217657 application number: ANDA217657 ndc (product): 68083-584

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
238014	carboprost tromethamine 250 MCG in 1 ML Injection	PSN	5902edd8-16b3-4f52-ac35-b0f4dfb5ab6a	2
238014	1 ML carboprost 0.25 MG/ML Injection	SCD	5902edd8-16b3-4f52-ac35-b0f4dfb5ab6a	2
238014	carboprost 250 MCG per 1 ML Injection	SY	5902edd8-16b3-4f52-ac35-b0f4dfb5ab6a	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68083-584-10	68083058410	10 VIAL in 1 CARTON (68083-584-10) / 1 mL in 1 VIAL	10 vial	2023-08-07	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carboprost Tromethamine Injection, USP 250 mcg/mL (1 mL) Rx Only	Gland Pharma Limited	2023-08-08	Human Prescription Drug Label	2