EPHEDRINE SULFATE

Product NDC: 42023-253
11-digit product format: 420230253
Labeler code: 42023
Product ID: 42023-253_ff906bee-e4eb-4800-b67d-8b0125beb7dd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ephedrine Sulfate
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Par Pharmaceutical, Inc.
Application: NDA213994
Marketing category: NDA
Marketing start: 2022-05-31
Marketing end: 0000-00-00
Substance: EPHEDRINE SULFATE
Active strength: 5 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	42023-253		D	Discontinued by firm		2026-08-10
excluded package	package	42023-253	42023-253-05	D	Discontinued by firm		2026-08-10

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42023-253-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42023-253-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42023-253-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42023-253-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42023-253-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42023-253-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42023-253-05	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42023-253-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42023-253-05	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42023-253-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42023-253-05	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42023-253-05	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

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
N213994-001	EPHEDRINE SULFATE	EPHEDRINE SULFATE	50MG/10ML (5MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2020-10-16
N213994-002	EPHEDRINE SULFATE	EPHEDRINE SULFATE	25MG/5ML (5MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2022-04-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N213994-001	AP2
N213994-002	AP2

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213994-001	10869845	2040-01-22		Drug product	2020-12-22
N213994-002	10869845	2040-01-22		Drug product	2022-05-19
N213994-002	12029710	2040-01-22	U-3963		2024-07-16

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 · 65 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
2026-02-19 14:30 UTC	2026-02	N213994-001	EPHEDRINE SULFATE	50MG/10ML (5MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2020-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213994-002	EPHEDRINE SULFATE	25MG/5ML (5MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2022-04-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213994-001	EPHEDRINE SULFATE	50MG/10ML (5MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2020-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213994-002	EPHEDRINE SULFATE	25MG/5ML (5MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2022-04-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213994-001	EPHEDRINE SULFATE	50MG/10ML (5MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2020-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213994-002	EPHEDRINE SULFATE	25MG/5ML (5MG/ML)	SOLUTION / INTRAVENOUS	AP2	RLD, RS	2022-04-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213994-001	EPHEDRINE SULFATE	50MG/10ML (5MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2020-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213994-002	EPHEDRINE SULFATE	25MG/5ML (5MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2022-04-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213994-001	EPHEDRINE SULFATE	50MG/10ML (5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213994-002	EPHEDRINE SULFATE	25MG/5ML (5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2022-04-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213994-001	EPHEDRINE SULFATE	50MG/10ML (5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213994-002	EPHEDRINE SULFATE	25MG/5ML (5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2022-04-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213994-001	EPHEDRINE SULFATE	50MG/10ML (5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213994-002	EPHEDRINE SULFATE	25MG/5ML (5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2022-04-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213994-001	EPHEDRINE SULFATE	50MG/10ML (5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213994-002	EPHEDRINE SULFATE	25MG/5ML (5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2022-04-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213994-001	EPHEDRINE SULFATE	50MG/10ML (5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-10-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213994-002	EPHEDRINE SULFATE	25MG/5ML (5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2022-04-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213994-001	EPHEDRINE SULFATE	50MG/10ML (5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-10-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213994-002	EPHEDRINE SULFATE	25MG/5ML (5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2022-04-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213994-001	EPHEDRINE SULFATE	50MG/10ML (5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-10-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213994-002	EPHEDRINE SULFATE	25MG/5ML (5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2022-04-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213994-001	EPHEDRINE SULFATE	50MG/10ML (5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-10-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213994-002	EPHEDRINE SULFATE	25MG/5ML (5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2022-04-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213994-001	EPHEDRINE SULFATE	50MG/10ML (5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-10-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213994-002	EPHEDRINE SULFATE	25MG/5ML (5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2022-04-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213994-001	EPHEDRINE SULFATE	50MG/10ML (5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-10-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N213994-002	EPHEDRINE SULFATE	25MG/5ML (5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2022-04-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213994-001	EPHEDRINE SULFATE	50MG/10ML (5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-10-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213994-002	EPHEDRINE SULFATE	25MG/5ML (5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2022-04-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213994-001	EPHEDRINE SULFATE	50MG/10ML (5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-10-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213994-001	EPHEDRINE SULFATE	50MG/10ML (5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-10-16	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213994-001	EPHEDRINE SULFATE	50MG/10ML (5MG/ML)	SOLUTION / INTRAVENOUS		RLD	2020-10-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213994-001	EPHEDRINE SULFATE	50MG/10ML (5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-10-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213994-001	EPHEDRINE SULFATE	50MG/10ML (5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-10-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N213994-001	EPHEDRINE SULFATE	50MG/10ML (5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-10-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N213994-001	EPHEDRINE SULFATE	50MG/10ML (5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-10-16	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213994-001	EPHEDRINE SULFATE	50MG/10ML (5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-10-16	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213994-002	EPHEDRINE SULFATE	25MG/5ML (5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2022-04-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213994-001	EPHEDRINE SULFATE	50MG/10ML (5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-10-16	`1c564ffb4f44…`

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	N213994-001	AP2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213994-002	AP2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213994-001	AP2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213994-002	AP2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213994-001	AP2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213994-002	AP2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213994-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213994-002	AP	1	`fd3edfee7708…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213994-001	AP2	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213994-002	AP2	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N213994-001	10869845	2040-01-22		Drug product	2020-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213994-002	10869845	2040-01-22		Drug product	2022-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213994-002	12029710	2040-01-22	U-3963		2024-07-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213994-001	10869845	2040-01-22		Drug product	2020-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213994-002	10869845	2040-01-22		Drug product	2022-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213994-002	12029710	2040-01-22	U-3963		2024-07-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213994-001	10869845	2040-01-22		Drug product	2020-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213994-002	10869845	2040-01-22		Drug product	2022-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213994-002	12029710	2040-01-22	U-3963		2024-07-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213994-001	10869845	2040-01-22		Drug product	2020-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213994-002	10869845	2040-01-22		Drug product	2022-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213994-002	12029710	2040-01-22	U-3963		2024-07-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213994-001	10869845	2040-01-22		Drug product	2020-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213994-002	10869845	2040-01-22		Drug product	2022-05-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213994-002	12029710	2040-01-22	U-3963		2024-07-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213994-001	10869845	2040-01-22		Drug product	2020-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213994-002	10869845	2040-01-22		Drug product	2022-05-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213994-002	12029710	2040-01-22	U-3963		2024-07-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213994-001	10869845	2040-01-22		Drug product	2020-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213994-002	10869845	2040-01-22		Drug product	2022-05-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213994-002	12029710	2040-01-22	U-3963		2024-07-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213994-001	10869845	2040-01-22		Drug product	2020-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213994-002	10869845	2040-01-22		Drug product	2022-05-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213994-002	12029710	2040-01-22	U-3963		2024-07-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213994-001	10869845	2040-01-22		Drug product	2020-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213994-002	10869845	2040-01-22		Drug product	2022-05-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213994-002	12029710	2040-01-22	U-3963		2024-07-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213994-001	10869845	2040-01-22		Drug product	2020-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213994-002	10869845	2040-01-22		Drug product	2022-05-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213994-002	12029710	2040-01-22	U-3963		2024-07-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213994-001	10869845	2040-01-22		Drug product	2020-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213994-002	10869845	2040-01-22		Drug product	2022-05-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213994-002	12029710	2040-01-22	U-3963		2024-07-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213994-001	10869845	2040-01-22		Drug product	2020-12-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213994-002	10869845	2040-01-22		Drug product	2022-05-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213994-001	10869845	2040-01-22		Drug product	2020-12-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213994-002	10869845	2040-01-22		Drug product	2022-05-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213994-001	10869845	2040-01-22		Drug product	2020-12-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N213994-002	10869845	2040-01-22		Drug product	2022-05-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213994-001	10869845	2040-01-22		Drug product	2020-12-22	`5c6f7cd8ea54…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d1bd959e-e326-44fb-b8ca-8c56a84a2a3d	Product name	2	20251211
f1d178e1-1663-4c63-ae37-62a1b322fba4	Product name	2	20251106
f606d3ac-dd63-4b29-bea0-db23753b8ddc	Product name	1	20220118
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
30254138-2d98-4aa2-8e07-ae82e8b0a389	Product name	3	20171103
fee762de-ffd9-404d-8bc6-8c0c208e758d	Product name	1	20170426
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42023-253-05	EPHEDRINE SULFATE	5 mL in 1 SYRINGE	INJECTION	5		11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42023-253	EPHEDRINE SULFATE INJECTION [ENDO USA, INC.]	9	Legacy NDC, 1 package rows	20240425_2c203482-8a04-40fc-93d2-74b30dec7742.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
EPHEDRINE SULFATE	EPHEDRINE SULFATE	Par Health USA, LLC	a247857e-ba7b-4a37-b132-4ba9b0d1c4d1	2023-05-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213994 application number: NDA213994
EPHEDRINE SULFATE	EPHEDRINE SULFATE	Par Health USA, LLC	2c203482-8a04-40fc-93d2-74b30dec7742	2022-04-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213994 application number: NDA213994 ndc (product): 42023-253

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2586841	ePHEDrine sulfate 25 MG in 5 ML Prefilled Syringe	PSN	2c203482-8a04-40fc-93d2-74b30dec7742	11
2368456	ePHEDrine sulfate 50 MG in 10 ML Injection	PSN	2c203482-8a04-40fc-93d2-74b30dec7742	11
2368456	10 ML ephedrine sulfate 5 MG/ML Injection	SCD	2c203482-8a04-40fc-93d2-74b30dec7742	11
2586841	5 ML ephedrine sulfate 5 MG/ML Prefilled Syringe	SCD	2c203482-8a04-40fc-93d2-74b30dec7742	11
2586841	ephedrine sulfate 25 MG (equivalent to 19 MG ephedrine) per 5 ML Prefilled Syringe	SY	2c203482-8a04-40fc-93d2-74b30dec7742	11
2368456	ephedrine sulfate 50 MG per 10 ML Injection	SY	2c203482-8a04-40fc-93d2-74b30dec7742	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42023-253-05	42023025305	5 mL in 1 SYRINGE (42023-253-05)	5 ml	2022-05-31	0000-00-00	No	No	Current