Hemabate

Product NDC: 0009-0856
11-digit product format: 000090856
Labeler code: 0009
Product ID: 0009-0856_7321f382-9653-4cdb-99ac-96384dd06abb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: carboprost tromethamine
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR
Labeler: Pharmacia & Upjohn Company LLC
Application: NDA017989
Marketing category: NDA
Marketing start: 1979-01-09
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 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
N017989-001	HEMABATE	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N017989-001	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	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N017989-001	HEMABATE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017989-001	HEMABATE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017989-001	HEMABATE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017989-001	HEMABATE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017989-001	HEMABATE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017989-001	HEMABATE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017989-001	HEMABATE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017989-001	HEMABATE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017989-001	HEMABATE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017989-001	HEMABATE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017989-001	HEMABATE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017989-001	HEMABATE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017989-001	HEMABATE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017989-001	HEMABATE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017989-001	HEMABATE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017989-001	HEMABATE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017989-001	HEMABATE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017989-001	HEMABATE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017989-001	HEMABATE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017989-001	HEMABATE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017989-001	HEMABATE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017989-001	HEMABATE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017989-001	HEMABATE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017989-001	HEMABATE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017989-001	HEMABATE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017989-001	HEMABATE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017989-001	HEMABATE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017989-001	HEMABATE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017989-001	HEMABATE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017989-001	HEMABATE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017989-001	HEMABATE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017989-001	HEMABATE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017989-001	HEMABATE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017989-001	HEMABATE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017989-001	HEMABATE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017989-001	HEMABATE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017989-001	HEMABATE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017989-001	HEMABATE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017989-001	HEMABATE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017989-001	HEMABATE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N017989-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017989-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017989-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017989-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017989-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017989-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017989-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017989-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017989-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017989-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017989-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017989-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017989-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017989-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017989-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017989-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017989-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017989-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017989-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017989-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017989-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017989-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017989-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017989-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017989-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017989-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017989-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017989-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017989-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017989-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017989-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017989-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017989-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017989-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017989-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017989-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017989-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017989-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017989-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017989-001	AP	1	`cb3db0bc1861…`

Additional Listing Data#

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

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
213638	Internal RxNorm lookup
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
3d282998-ff0c-480a-bd80-155606ef0a65	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
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0009-0856-05	Hemabate	1 mL in 1 AMPULE	INJECTION, SOLUTION	1		14
0009-0856-08	Hemabate	10 in 1 PACKAGE	INJECTION, SOLUTION	10		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0009-0856-05	ML - Milliliter	0009-0856	95296270-074a-43ea-ab7b-5e249e9b85b2	1	2013-04-01
0009-0856-08	ML - Milliliter	0009-0856	7de565f8-5687-49b0-bea5-347caec7fb77	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CARBOPROST TROMETHAMINE	ACTIVE INGREDIENT	U4526F86FJ	HEMABATE (CARBOPROST TROMETHAMINE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]	6
CARBOPROST	ACTIVE MOIETY	7B5032XT6O	HEMABATE (CARBOPROST TROMETHAMINE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]	6
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	HEMABATE (CARBOPROST TROMETHAMINE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]	6
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	HEMABATE (CARBOPROST TROMETHAMINE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]	6
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	HEMABATE (CARBOPROST TROMETHAMINE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]	6
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	HEMABATE (CARBOPROST TROMETHAMINE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]	6
TROMETHAMINE	INACTIVE INGREDIENT	023C2WHX2V	HEMABATE (CARBOPROST TROMETHAMINE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0009-0856	HEMABATE (CARBOPROST TROMETHAMINE) INJECTION, SOLUTION [PHARMACIA & UPJOHN COMPANY LLC]	12	Current NDC, Legacy NDC, 2 package rows	20250406_3d282998-ff0c-480a-bd80-155606ef0a65.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hemabate	CARBOPROST TROMETHAMINE	Pharmacia & Upjohn Company LLC	3d282998-ff0c-480a-bd80-155606ef0a65	2026-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017989 application number: NDA017989 ndc (product): 0009-0856

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	3d282998-ff0c-480a-bd80-155606ef0a65	14
213638	Hemabate 250 MCG in 1 ML Injection	PSN	3d282998-ff0c-480a-bd80-155606ef0a65	14
213638	1 ML carboprost 0.25 MG/ML Injection [Hemabate]	SBD	3d282998-ff0c-480a-bd80-155606ef0a65	14
238014	1 ML carboprost 0.25 MG/ML Injection	SCD	3d282998-ff0c-480a-bd80-155606ef0a65	14
213638	1 ML Hemabate 0.25 MG/ML Injection	SY	3d282998-ff0c-480a-bd80-155606ef0a65	14
238014	carboprost 250 MCG per 1 ML Injection	SY	3d282998-ff0c-480a-bd80-155606ef0a65	14
213638	Hemabate 250 MCG per 1 ML Injection	SY	3d282998-ff0c-480a-bd80-155606ef0a65	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0009-0856-05	00009085605	1 mL in 1 AMPULE (0009-0856-05)	1 ml	1979-01-09	0000-00-00	No	No	Current
0009-0856-08	00009085608	10 AMPULE in 1 PACKAGE (0009-0856-08) / 1 mL in 1 AMPULE (0009-0856-05)	10 ampule	1979-01-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hemabate ® carboprost tromethamine injection, USP	Pharmacia & Upjohn Company LLC	2026-03-30	HUMAN PRESCRIPTION DRUG LABEL	14