EPHEDRINE SULFATE

Product NDC
51662-1325
11-digit product format
516621325
Labeler code
51662
Product ID
51662-1325_12509d90-9606-7834-e063-6394a90a9a8f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
EPHEDRINE SULFATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
NDA208943
Marketing category
NDA
Marketing start
2018-10-21
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N208943-001CORPHEDRAEPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2017-01-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N208943-001AP

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N208943-001CORPHEDRA50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2017-01-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208943-001CORPHEDRA50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2017-01-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N208943-001CORPHEDRA50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2017-01-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208943-001CORPHEDRA50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2017-01-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208943-001CORPHEDRA50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2017-01-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208943-001CORPHEDRA50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2017-01-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208943-001CORPHEDRA50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2017-01-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208943-001CORPHEDRA50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2017-01-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208943-001CORPHEDRA50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2017-01-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N208943-001CORPHEDRA50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2017-01-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208943-001CORPHEDRA50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2017-01-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N208943-001CORPHEDRA50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2017-01-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N208943-001CORPHEDRA50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2017-01-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05N208943-001CORPHEDRA50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2017-01-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N208943-001CORPHEDRA50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2017-01-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N208943-001CORPHEDRA50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2017-01-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N208943-001CORPHEDRA50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2017-01-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N208943-001CORPHEDRA50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2017-01-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N208943-001CORPHEDRA50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2017-01-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N208943-001CORPHEDRA50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2017-01-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N208943-001CORPHEDRA50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2017-01-2787673890dc5c…
2021-03-12 10:30 UTC2021-03N208943-001CORPHEDRA50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2017-01-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N208943-001CORPHEDRA50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2017-01-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11N208943-001CORPHEDRA50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2017-01-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12N208943-001CORPHEDRA50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2017-01-273f01610625f2…
2019-09-15 20:21 UTC2019-09N208943-001CORPHEDRA50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2017-01-27b00525d2431f…
2019-07-19 19:46 UTC2019-07N208943-001CORPHEDRA50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2017-01-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N208943-001CORPHEDRA50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2017-01-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N208943-001CORPHEDRA50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2017-01-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12N208943-001CORPHEDRA50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2017-01-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N208943-001CORPHEDRA50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2017-01-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N208943-001CORPHEDRA50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2017-01-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N208943-001CORPHEDRA50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2017-01-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N208943-001CORPHEDRA50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2017-01-273f0d92c62455…
2023-05-13 08:27 UTC2023-05N208943-001CORPHEDRA50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2017-01-27053a50430f4f…
2023-01-26 05:58 UTC2023-01N208943-001CORPHEDRA50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2017-01-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N208943-001CORPHEDRA50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2017-01-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N208943-001CORPHEDRA50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2017-01-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N208943-001CORPHEDRA50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2017-01-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N208943-001CORPHEDRA50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2017-01-27cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N208943-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208943-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N208943-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208943-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208943-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208943-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208943-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208943-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208943-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N208943-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208943-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N208943-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N208943-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N208943-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N208943-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N208943-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N208943-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N208943-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N208943-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N208943-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N208943-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N208943-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N208943-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N208943-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N208943-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N208943-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N208943-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N208943-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N208943-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N208943-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N208943-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N208943-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N208943-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N208943-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05N208943-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01N208943-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N208943-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N208943-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N208943-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N208943-001AP1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
EPHEDRINE SULFATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EPHEDRINE SULFATE50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U6X61U5ZEGInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1116294Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
78c1daef-6e1e-5f2c-e053-2a91aa0a0dbaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1bd959e-e326-44fb-b8ca-8c56a84a2a3dProduct name220251211
f1d178e1-1663-4c63-ae37-62a1b322fba4Product name220251106
f606d3ac-dd63-4b29-bea0-db23753b8ddcProduct name120220118
30254138-2d98-4aa2-8e07-ae82e8b0a389Product name320171103
fee762de-ffd9-404d-8bc6-8c0c208e758dProduct name120170426

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1325-1EPHEDRINE SULFATE1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1325EPHEDRINE SULFATE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]5Current NDC, Legacy NDC, 1 package rows20240228_78c1daef-6e1e-5f2c-e053-2a91aa0a0dba.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ephedrine SulfateEPHEDRINE SULFATEPar Health USA, LLC38723cb3-dfca-4c81-8c6f-63dd999291912026-03-17Warnings, Adverse reactionsExact identifier
application applno (NDA): 208943
application number: NDA208943
Ephedrine SulfateEPHEDRINE SULFATEPar Health USA, LLC3e43cc8e-bf4e-44ef-a07d-4336367b9bdb2026-01-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 208943
application number: NDA208943
EPHEDRINE SULFATEEPHEDRINE SULFATEHF Acquisition Co LLC, DBA HealthFirst78c1daef-6e1e-5f2c-e053-2a91aa0a0dba2024-02-26Warnings, Adverse reactionsExact identifier
application applno (NDA): 208943
application number: NDA208943
ndc (product): 51662-1325

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116294ePHEDrine sulfate 50 MG in 1 ML InjectionPSN78c1daef-6e1e-5f2c-e053-2a91aa0a0dba5
11162941 ML ephedrine sulfate 50 MG/ML InjectionSCD78c1daef-6e1e-5f2c-e053-2a91aa0a0dba5
1116294ephedrine sulfate 50 MG per 1 ML InjectionSY78c1daef-6e1e-5f2c-e053-2a91aa0a0dba5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1325-1516621325011 mL in 1 VIAL, SINGLE-DOSE (51662-1325-1) 1 ml2018-10-210000-00-00NoNoCurrent