Terbutaline Sulfate

Product NDC: 52584-665
Requested package NDC: 52584-665-01
11-digit product format: 525840665
Labeler code: 52584
Product ID: 52584-665_0ba29411-e95d-4bee-aee1-e3a135d6aa33
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Terbutaline Sulfate
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: General Injectables & Vaccines, Inc
Application: ANDA076887
Marketing category: ANDA
Marketing start: 2011-11-16
Marketing end: 2024-03-31
Substance: TERBUTALINE SULFATE
Active strength: 1 mg/mL
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	52584-665	52584-665-01	D	Discontinued by firm		2026-08-17

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A076887-001	TERBUTALINE SULFATE	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2004-05-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076887-001	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 · 42 observed 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
2026-08-18 06:07:40	2026-07	A076887-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	2004-05-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076887-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	2004-05-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076887-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	2004-05-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076887-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	2004-05-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076887-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	2004-05-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076887-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	2004-05-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076887-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	2004-05-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076887-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	2004-05-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076887-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	2004-05-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076887-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	2004-05-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076887-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	2004-05-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076887-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	2004-05-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076887-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	2004-05-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076887-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	2004-05-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076887-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	2004-05-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076887-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	2004-05-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076887-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	2004-05-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076887-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	2004-05-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076887-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	2004-05-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076887-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	2004-05-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076887-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	2004-05-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076887-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	2004-05-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076887-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	2004-05-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076887-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	2004-05-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076887-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	2004-05-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076887-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	2004-05-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076887-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	2004-05-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076887-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	2004-05-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076887-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	2004-05-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076887-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	2004-05-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076887-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	2004-05-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076887-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	2004-05-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076887-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	2004-05-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076887-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	2004-05-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076887-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	2004-05-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076887-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	2004-05-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076887-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	2004-05-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076887-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	2004-05-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076887-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	2004-05-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076887-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	2004-05-26	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A076887-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076887-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076887-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076887-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076887-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076887-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076887-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076887-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076887-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076887-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076887-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076887-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076887-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076887-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076887-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076887-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076887-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076887-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076887-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076887-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076887-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076887-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076887-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076887-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076887-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076887-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076887-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076887-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076887-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076887-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076887-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076887-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076887-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076887-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076887-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076887-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076887-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076887-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076887-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076887-001	AP	1	`e64feba35796…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
Terbutaline Sulfate	ACTIVE INGREDIENT	576PU70Y8E	TERBUTALINE SULFATE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	1
Terbutaline	ACTIVE MOIETY	N8ONU3L3PG	TERBUTALINE SULFATE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	1

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
Terbutaline Sulfate	TERBUTALINE SULFATE	Henry Schein, Inc.	9f4b177e-4d7d-4255-afeb-522c7d4594c6	2025-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076887 application number: ANDA076887
Terbutaline Sulfate	TERBUTALINE SULFATE	Fresenius Kabi USA, LLC	cec31032-f366-4524-9e01-63146e473b2b	2022-07-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076887 application number: ANDA076887

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
576PU70Y8E	TERBUTALINE SULFATE	23031-32-5	TERBUTALINE SULFATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52584-665-01	52584066501	1 VIAL in 1 BAG (52584-665-01) > 1 mL in 1 VIAL	1 vial	2011-11-16	2024-03-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Terbutaline Sulfate Injection, USP 1mg/mL 1mL single dose vial	General Injectables & Vaccines, Inc	2022-12-27	HUMAN PRESCRIPTION DRUG LABEL	6