Application 212932

Type: ANDA
Sponsor: AMNEAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EPHEDRINE SULFATE	EPHEDRINE SULFATE	SOLUTION;INTRAVENOUS	50MG/ML (50MG/ML)	No	No

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
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
2026-08-18 06:07:40	2026-07	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`caaa826d4ba7…`
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
2026-08-18 06:07:40	2026-07	A212932-001	AP	1	`caaa826d4ba7…`
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 ndc (product): 16714-037
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 ndc (product): 70121-1637
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 ndc (product): 71872-7269
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 ndc (product): 71872-7257

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-037	Ephedrine Sulfate	Ephedrine Sulfate	NorthStar Rx LLC	ANDA	Current
16714-037	Ephedrine Sulfate	Ephedrine Sulfate	NorthStar Rx LLC	ANDA	Current
16714-037	Ephedrine Sulfate	Ephedrine Sulfate	NorthStar Rx LLC	ANDA	Current
16714-037	Ephedrine Sulfate	Ephedrine Sulfate	NorthStar Rx LLC	ANDA	Current
70121-1637	Ephedrine Sulfate	Ephedrine Sulfate	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1637	Ephedrine Sulfate	Ephedrine Sulfate	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1637	Ephedrine Sulfate	Ephedrine Sulfate	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1637	Ephedrine Sulfate	Ephedrine Sulfate	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1637	Ephedrine Sulfate	Ephedrine Sulfate	Amneal Pharmaceuticals LLC	ANDA	Current
71872-7257	Ephedrine Sulfate	Ephedrine Sulfate	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7269	Ephedrine Sulfate	Ephedrine Sulfate	Medical Purchasing Solutions, LLC	ANDA	Current
72572-151	Ephedrine Sulfate	Ephedrine Sulfate	Civica, Inc.	ANDA	Current
72572-151	Ephedrine Sulfate	Ephedrine Sulfate	Civica, Inc.	ANDA	Current
72572-151	Ephedrine Sulfate	Ephedrine Sulfate	Civica, Inc.	ANDA	Current