Terbutaline Sulfate

Product NDC: 67296-1053
Requested package NDC: 67296-1053-6
11-digit product format: 672961053
Labeler code: 67296
Product ID: 67296-1053_d60fb093-62d2-5fa7-e053-2995a90a3188
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Terbutaline Sulfate
Dosage form: TABLET
Route: ORAL
Labeler: RedPharm Drug, Inc.
Application: ANDA077152
Marketing category: ANDA
Marketing start: 2005-03-25
Marketing end: 0000-00-00
Substance: TERBUTALINE SULFATE
Active strength: 3 mg/1
NDC exclude flag: No
Listing certified through: 2023-12-31
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	67296-1053	67296-1053-6	I	Inactivated by FDA		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 · 16 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2019-12-08 06:16 UTC · source 2019-12-05	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077152-001	TERBUTALINE SULFATE	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25
A077152-002	TERBUTALINE SULFATE	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A077152-001	AB
A077152-002	AB

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 3 · 84 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	A077152-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077152-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077152-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077152-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077152-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077152-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077152-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077152-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077152-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077152-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077152-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077152-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077152-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077152-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077152-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077152-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077152-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077152-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077152-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077152-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077152-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077152-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077152-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077152-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077152-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077152-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077152-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077152-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077152-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077152-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077152-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077152-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077152-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077152-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077152-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077152-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077152-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077152-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077152-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077152-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A077152-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077152-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077152-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077152-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077152-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077152-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077152-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077152-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077152-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077152-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077152-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077152-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077152-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077152-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077152-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077152-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077152-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077152-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077152-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077152-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077152-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077152-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077152-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077152-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077152-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077152-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077152-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077152-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077152-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077152-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077152-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077152-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077152-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077152-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077152-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077152-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077152-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077152-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077152-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077152-002	AB	1	`bb7c543d1eb4…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67296-1053-6	2024-01-30	C162847	48780-1	1030e365-5c9d-111a-e063-dadaa90a10e2	4e400aef-05d0-2aea-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-1053-6	Terbutaline Sulfate	6 in 1 BOTTLE	TABLET	6		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-1053	TERBUTALINE SULFATE TABLET [REDPHARM DRUG, INC.]	3	Legacy NDC, 1 package rows	20220121_4e400aef-05d0-2aea-e054-00144ff88e88.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Terbutaline Sulfate	TERBUTALINE SULFATE	Chartwell RX, LLC.	859267c6-3d14-4123-9b9d-4fc248f09726	2025-12-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077152 application number: ANDA077152
Terbutaline Sulfate	TERBUTALINE SULFATE	Lannett Company, Inc.	fbf54709-5857-4dbc-9233-ebd7abff88c8	2020-11-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077152 application number: ANDA077152

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
857677	terbutaline sulfate 2.5 MG Oral Tablet	PSN	4e400aef-05d0-2aea-e054-00144ff88e88	3
857677	terbutaline sulfate 2.5 MG Oral Tablet	SCD	4e400aef-05d0-2aea-e054-00144ff88e88	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-1053-6	67296105306	6 TABLET in 1 BOTTLE (67296-1053-6)	6 tablet	2005-03-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Terbutaline Sulfate - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2022-01-20	HUMAN PRESCRIPTION DRUG LABEL	3