Ephedrine Sulfate

Product NDC: 72572-151
Requested package NDC: 72572-151-10
11-digit product format: 725720151
Labeler code: 72572
Product ID: 72572-151_854e6399-ce86-4576-8196-eb88e1941cb0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ephedrine Sulfate
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Civica, Inc.
Application: ANDA212932
Marketing category: ANDA
Marketing start: 2021-08-23
Marketing end: 0000-00-00
Substance: EPHEDRINE SULFATE
Active strength: 50 mg/mL
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Increased Norepinephrine Activity [PE], Norepinephrine Releasing Agent [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
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	72572-151	72572-151-10	D	Discontinued by firm		2026-08-03

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 · 11 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	72572-151	72572-151-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	72572-151	72572-151-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	72572-151	72572-151-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	72572-151	72572-151-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	72572-151	72572-151-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	72572-151	72572-151-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	72572-151	72572-151-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72572-151	72572-151-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72572-151	72572-151-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	72572-151	72572-151-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	72572-151	72572-151-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A212932-001	EPHEDRINE SULFATE	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP		2019-10-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212932-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212932-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212932-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212932-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212932-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212932-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212932-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212932-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212932-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212932-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212932-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212932-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212932-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212932-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212932-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212932-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212932-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212932-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212932-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212932-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212932-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212932-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212932-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212932-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212932-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212932-001	AP	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212932-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212932-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212932-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212932-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212932-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212932-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212932-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212932-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212932-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212932-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212932-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212932-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212932-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212932-001	AP	1	`a50c72e98297…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ephedrine Sulfate	EPHEDRINE SULFATE	NorthStar Rx LLC	7b29542f-3a32-4113-bb1c-1fbd280046e2	2024-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212932 application number: ANDA212932
Ephedrine Sulfate	EPHEDRINE SULFATE	Amneal Pharmaceuticals LLC	765ed48b-b381-418a-9847-068f7f4cc838	2024-12-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212932 application number: ANDA212932
Ephedrine Sulfate	EPHEDRINE SULFATE	Medical Purchasing Solutions, LLC	d163ff39-d1a4-b61f-e053-2995a90ab6d5	2023-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212932 application number: ANDA212932
Ephedrine Sulfate	EPHEDRINE SULFATE	Medical Purchasing Solutions, LLC	c8e8ec0e-988b-85a1-e053-2a95a90a2268	2023-04-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212932 application number: ANDA212932

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72572-151-01	ML - Milliliter	72572-151	3dffe557-410f-48b1-ac77-ee335f12d706	1	2021-09-07
72572-151-10	ML - Milliliter	72572-151	5b3a7056-fb5d-474b-b8b5-af5531462283	1	2021-09-07

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U6X61U5ZEG	EPHEDRINE SULFATE	134-72-5	EPHEDRINE SULFATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72572-151-10	72572015110	1 VIAL, SINGLE-DOSE in 1 CARTON (72572-151-10) > 1 mL in 1 VIAL, SINGLE-DOSE (72572-151-01)	2021-08-23	0000-00-00	No	No	Current