Terbutaline Sulfate

Product NDC: 0143-9746
11-digit product format: 001439746
Labeler code: 0143
Product ID: 0143-9746_3e8736f7-de5c-4906-851f-6a10a53866ad
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Terbutaline Sulfate
Dosage form: INJECTION
Route: SUBCUTANEOUS
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA078630
Marketing category: ANDA
Marketing start: 2009-05-20
Substance: TERBUTALINE SULFATE
Active strength: 1 mg/mL
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 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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Terbutaline Sulfate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TERBUTALINE SULFATE	1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
576PU70Y8E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
857635	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
613df3cb-4d55-4d12-ab08-a932481aaa0b	Available on FDA.report

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
0143-9746-01	Terbutaline Sulfate	1 mL in 1 VIAL	INJECTION	1		9
0143-9746-10	Terbutaline Sulfate	10 in 1 CARTON	INJECTION	10		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0143-9746-01	ML - Milliliter	0143-9746	6069288e-2c5f-4639-9249-42056ff0322d	1	2018-07-03
0143-9746-10	ML - Milliliter	0143-9746	c8480ad0-fbf9-4a52-98ef-c0b8345c1ec1	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TERBUTALINE SULFATE	ACTIVE INGREDIENT	576PU70Y8E	TERBUTALINE SULFATE INJECTION [WEST-WARD PHARMACEUTICAL CORP]	6
TERBUTALINE	ACTIVE MOIETY	N8ONU3L3PG	TERBUTALINE SULFATE INJECTION [WEST-WARD PHARMACEUTICAL CORP]	6
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	TERBUTALINE SULFATE INJECTION [WEST-WARD PHARMACEUTICAL CORP]	6
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	TERBUTALINE SULFATE INJECTION [WEST-WARD PHARMACEUTICAL CORP]	6
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	TERBUTALINE SULFATE INJECTION [WEST-WARD PHARMACEUTICAL CORP]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0143-9746	TERBUTALINE SULFATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]	9	Current NDC, Legacy NDC, 2 package rows	20240105_613df3cb-4d55-4d12-ab08-a932481aaa0b.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 · 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 ndc (product): 0143-9746
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
857635	terbutaline sulfate 1 MG in 1 ML Injection	PSN	613df3cb-4d55-4d12-ab08-a932481aaa0b	9
857635	1 ML terbutaline sulfate 1 MG/ML Injection	SCD	613df3cb-4d55-4d12-ab08-a932481aaa0b	9
857635	terbutaline sulfate 1 MG per 1 ML Injection	SY	613df3cb-4d55-4d12-ab08-a932481aaa0b	9
857635	terbutaline sulfate 1 MG in 1 ML Injection	PSN	6a22b62c-4ee1-49df-e053-2a91aa0a3e52	4
857635	1 ML terbutaline sulfate 1 MG/ML Injection	SCD	6a22b62c-4ee1-49df-e053-2a91aa0a3e52	4
857635	terbutaline sulfate 1 MG per 1 ML Injection	SY	6a22b62c-4ee1-49df-e053-2a91aa0a3e52	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0143-9746-01	00143974601	1 mL in 1 VIAL	1 ml					Historical
0143-9746-10	00143974610	10 VIAL in 1 CARTON (0143-9746-10) / 1 mL in 1 VIAL (0143-9746-01)	10 vial	2009-05-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TERBUTALINE SULFATE INJECTION	Henry Schein, Inc.	2025-08-28	HUMAN PRESCRIPTION DRUG LABEL	1
TERBUTALINE SULFATE INJECTION, USP	Hikma Pharmaceuticals USA Inc.	2024-01-04	HUMAN PRESCRIPTION DRUG LABEL	9
TERBUTALINE SULFATE INJECTION, USP	Medical Purchasing Solutions. LLC \| Medical Purchasing Solutions, LLC	2023-05-23	HUMAN PRESCRIPTION DRUG LABEL	4