Ephedrine Sulfate

Product NDC
71872-7269
11-digit product format
718727269
Labeler code
71872
Product ID
71872-7269_fab7b912-fbe9-1572-e053-6294a90a64d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ephedrine Sulfate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Medical Purchasing Solutions, LLC
Application
ANDA212932
Marketing category
ANDA
Marketing start
2019-10-23
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
A212932-001EPHEDRINE SULFATEEPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2019-10-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212932-001AP

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A212932-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2019-10-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212932-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2019-10-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A212932-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2019-10-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212932-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2019-10-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212932-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2019-10-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212932-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2019-10-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212932-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2019-10-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212932-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2019-10-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212932-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2019-10-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212932-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2019-10-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212932-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2019-10-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212932-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2019-10-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212932-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2019-10-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212932-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2019-10-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212932-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2019-10-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212932-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2019-10-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212932-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2019-10-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A212932-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2019-10-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A212932-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2019-10-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212932-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2019-10-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212932-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2019-10-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A212932-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2019-10-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A212932-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2019-10-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A212932-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2019-10-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A212932-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2019-10-233f01610625f2…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212932-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2019-10-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212932-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2019-10-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212932-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2019-10-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212932-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2019-10-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212932-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2019-10-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212932-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2019-10-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212932-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2019-10-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A212932-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2019-10-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A212932-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2019-10-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212932-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2019-10-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A212932-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2019-10-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A212932-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2019-10-23e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212932-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2019-10-23cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212932-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2019-10-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A212932-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212932-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212932-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212932-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212932-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212932-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212932-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212932-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212932-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212932-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212932-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212932-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212932-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212932-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212932-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212932-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212932-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A212932-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A212932-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212932-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212932-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A212932-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A212932-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A212932-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A212932-001AP13f01610625f2…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212932-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212932-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212932-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212932-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212932-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212932-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212932-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A212932-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A212932-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212932-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A212932-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A212932-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212932-001AP1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212932-001AP1a50c72e98297…

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
d163ff39-d1a4-b61f-e053-2995a90ab6d5Available 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
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
30254138-2d98-4aa2-8e07-ae82e8b0a389Product name320171103
fee762de-ffd9-404d-8bc6-8c0c208e758dProduct name120170426
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71872-7269-1Ephedrine Sulfate1 in 1 BAGINJECTION13
71872-7269-1Ephedrine Sulfate1 mL in 1 VIAL, SINGLE-DOSEINJECTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71872-7269EPHEDRINE SULFATE INJECTION [MEDICAL PURCHASING SOLUTIONS, LLC]3Current NDC, Legacy NDC, 2 package rows20230504_d163ff39-d1a4-b61f-e053-2995a90ab6d5.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ephedrine SulfateEPHEDRINE SULFATENorthStar Rx LLC7b29542f-3a32-4113-bb1c-1fbd280046e22024-12-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212932
application number: ANDA212932
Ephedrine SulfateEPHEDRINE SULFATEAmneal Pharmaceuticals LLC765ed48b-b381-418a-9847-068f7f4cc8382024-12-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212932
application number: ANDA212932
Ephedrine SulfateEPHEDRINE SULFATEMedical Purchasing Solutions, LLCd163ff39-d1a4-b61f-e053-2995a90ab6d52023-05-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212932
application number: ANDA212932
ndc (product): 71872-7269
Ephedrine SulfateEPHEDRINE SULFATEMedical Purchasing Solutions, LLCc8e8ec0e-988b-85a1-e053-2a95a90a22682023-04-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212932
application number: ANDA212932

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116294ePHEDrine sulfate 50 MG in 1 ML InjectionPSNd163ff39-d1a4-b61f-e053-2995a90ab6d53
11162941 ML ephedrine sulfate 50 MG/ML InjectionSCDd163ff39-d1a4-b61f-e053-2995a90ab6d53
1116294ephedrine sulfate 50 MG per 1 ML InjectionSYd163ff39-d1a4-b61f-e053-2995a90ab6d53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71872-7269-1718727269011 VIAL, SINGLE-DOSE in 1 BAG (71872-7269-1) / 1 mL in 1 VIAL, SINGLE-DOSE2021-10-110000-00-00NoNoCurrent