Terbutaline Sulfate

Product NDC: 0143-9375
11-digit product format: 001439375
Labeler code: 0143
Product ID: 0143-9375_c46b3216-1e79-4473-b4f3-951fd506ab92
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
0f4d3249-e022-40b6-b93d-f605e8522207	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
49ccb555-d142-0761-ee45-2e1304b37b1d	Product name	2	20210111
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
a3c04a67-87ea-e8b8-0458-db8085ac6340	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0143-9375-01	Terbutaline Sulfate	1 mL in 1 VIAL	INJECTION	1		2
0143-9375-10	Terbutaline Sulfate	10 in 1 CARTON	INJECTION	10		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0143-9375	TERBUTALINE SULFATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]	2	Current NDC, Legacy NDC, 2 package rows	20220815_0f4d3249-e022-40b6-b93d-f605e8522207.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
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 ndc (product): 0143-9375

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	0f4d3249-e022-40b6-b93d-f605e8522207	2
857635	1 ML terbutaline sulfate 1 MG/ML Injection	SCD	0f4d3249-e022-40b6-b93d-f605e8522207	2
857635	terbutaline sulfate 1 MG per 1 ML Injection	SY	0f4d3249-e022-40b6-b93d-f605e8522207	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0143-9375-01	00143937501	1 mL in 1 VIAL	1 ml					Historical
0143-9375-10	00143937510	10 VIAL in 1 CARTON (0143-9375-10) / 1 mL in 1 VIAL (0143-9375-01)	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, USP	Hikma Pharmaceuticals USA Inc. \| HIKMA FARMACEUTICA (PORTUGAL), S.A.	2020-10-01	HUMAN PRESCRIPTION DRUG LABEL	2