Terbutaline Sulfate

Product NDC: 0404-9778
11-digit product format: 004049778
Labeler code: 0404
Product ID: 0404-9778_d7e57299-acd7-41cf-9cfb-229cba799be6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: terbutaline sulfate
Dosage form: INJECTION
Route: SUBCUTANEOUS
Labeler: Henry Schein, Inc.
Application: ANDA078630
Marketing category: ANDA
Marketing start: 2025-10-07
Substance: TERBUTALINE SULFATE
Active strength: 1 mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0404-9778		D	Discontinued by firm		2026-08-17
excluded package	package	0404-9778	0404-9778-01	D	Discontinued by firm		2026-08-17

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
A078630-001	TERBUTALINE SULFATE	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2009-05-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078630-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2009-05-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2009-05-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2009-05-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2009-05-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2009-05-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2009-05-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP	RS	2009-05-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078630-001	TERBUTALINE SULFATE	1MG/ML	INJECTABLE / INJECTION	AP		2009-05-20	`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	A078630-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078630-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078630-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078630-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078630-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078630-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078630-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078630-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078630-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078630-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078630-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078630-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078630-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078630-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078630-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078630-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078630-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078630-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078630-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078630-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078630-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078630-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078630-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078630-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078630-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078630-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078630-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078630-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078630-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078630-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078630-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078630-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078630-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078630-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078630-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078630-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078630-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078630-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078630-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078630-001	AP	1	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
49ccb555-d142-0761-ee45-2e1304b37b1d	Product name	2	20210111
a3c04a67-87ea-e8b8-0458-db8085ac6340	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0404-9778-01	Terbutaline Sulfate	1 in 1 BAG	INJECTION	1		1
0404-9778-01	Terbutaline Sulfate	1 mL in 1 VIAL	INJECTION	1		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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Terbutaline Sulfate	TERBUTALINE SULFATE	Hikma Pharmaceuticals USA Inc.	613df3cb-4d55-4d12-ab08-a932481aaa0b	2024-01-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078630 application number: ANDA078630
Terbutaline Sulfate	TERBUTALINE SULFATE	Medical Purchasing Solutions. LLC	6a22b62c-4ee1-49df-e053-2a91aa0a3e52	2023-05-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078630 application number: ANDA078630
Terbutaline Sulfate	TERBUTALINE SULFATE	Hikma Pharmaceuticals USA Inc.	0f4d3249-e022-40b6-b93d-f605e8522207	2020-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078630 application number: ANDA078630

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	Sample	Exclude flag	Status
0404-9778-01	00404977801	1 VIAL in 1 BAG (0404-9778-01) / 1 mL in 1 VIAL	1 vial	2025-10-07	No	No	Historical