Ephedrine sulfate

Product NDC: 84549-611
Requested package NDC: 84549-611-25
11-digit product format: 845490611
Labeler code: 84549
Product ID: 84549-611_3a38b027-e8ea-5d08-e063-6294a90a3b49
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ephedrine sulfate
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: ProPharma Distribution
Application: ANDA216129
Marketing category: ANDA
Marketing start: 2022-04-15
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: 2026-12-31
Current FDA listing: Yes

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
A216129-001	EPHEDRINE SULFATE	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-04-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216129-001	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	A216129-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216129-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216129-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216129-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216129-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216129-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216129-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216129-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216129-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216129-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216129-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216129-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216129-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216129-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A216129-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-14	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216129-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216129-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216129-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216129-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216129-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216129-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216129-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216129-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216129-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216129-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A216129-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A216129-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A216129-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-14	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216129-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-14	`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	A216129-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216129-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216129-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216129-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216129-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216129-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216129-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216129-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216129-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216129-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216129-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216129-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216129-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216129-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A216129-001	AP	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216129-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216129-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216129-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216129-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216129-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216129-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216129-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216129-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216129-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216129-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A216129-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A216129-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A216129-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216129-001	AP	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ephedrine sulfate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
EPHEDRINE SULFATE	50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
U6X61U5ZEG	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1116294	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
3843c820-f54b-5349-e063-6294a90a6b18	Available on FDA.report

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
84549-611-25	Ephedrine sulfate	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION	1		3

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 RxLLC	b6fc8311-7853-4666-a1c2-668a04fe2119	2026-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216129 application number: ANDA216129
Ephedrine sulfate	EPHEDRINE SULFATE	ProPharma Distribution	3843c820-f54b-5349-e063-6294a90a6b18	2025-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216129 application number: ANDA216129 ndc (package): 84549-611-25 ndc (product): 84549-611 ndc11 (package): 84549061125
Ephedrine sulfate	EPHEDRINE SULFATE	Medical Purchasing Solutions, LLC	08f5ec19-7b53-681b-e063-6294a90acc86	2023-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216129 application number: ANDA216129
Ephedrine sulfate	EPHEDRINE SULFATE	Lifestar Pharma LLC	49fc67d1-3b30-456b-951c-ca7f703432ab	2022-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216129 application number: ANDA216129

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
1116294	ePHEDrine sulfate 50 MG in 1 ML Injection	PSN	3843c820-f54b-5349-e063-6294a90a6b18	3
1116294	1 ML ephedrine sulfate 50 MG/ML Injection	SCD	3843c820-f54b-5349-e063-6294a90a6b18	3
1116294	ephedrine sulfate 50 MG per 1 ML Injection	SY	3843c820-f54b-5349-e063-6294a90a6b18	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84549-611-25	84549061125	1 mL in 1 VIAL, SINGLE-DOSE (84549-611-25)	1 ml	2025-08-27	No	No	Current