Ephedrine sulfate

Product NDC
70756-611
11-digit product format
707560611
Labeler code
70756
Product ID
70756-611_abbedc8b-c9b5-4049-a31b-dbffb73c6556
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ephedrine sulfate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Lifestar Pharma LLC
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 42.

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
A216129-001EPHEDRINE SULFATEEPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2022-04-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A216129-001AP

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
2026-08-18 06:07:402026-07A216129-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2022-04-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216129-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2022-04-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216129-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2022-04-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A216129-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2022-04-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216129-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2022-04-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216129-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2022-04-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216129-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2022-04-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216129-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2022-04-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216129-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2022-04-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216129-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2022-04-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216129-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2022-04-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216129-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2022-04-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216129-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2022-04-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216129-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2022-04-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216129-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2022-04-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A216129-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2022-04-145c6f7cd8ea54…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A216129-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2022-04-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A216129-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2022-04-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A216129-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2022-04-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A216129-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2022-04-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A216129-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2022-04-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A216129-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2022-04-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A216129-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2022-04-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A216129-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2022-04-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A216129-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2022-04-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A216129-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2022-04-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A216129-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2022-04-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A216129-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2022-04-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A216129-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2022-04-14cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216129-001EPHEDRINE SULFATE50MG/ML (50MG/ML)SOLUTION / INTRAVENOUSAP2022-04-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A216129-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216129-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216129-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216129-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216129-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216129-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216129-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216129-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216129-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216129-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216129-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216129-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216129-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216129-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216129-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A216129-001AP15c6f7cd8ea54…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A216129-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A216129-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A216129-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A216129-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A216129-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A216129-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A216129-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A216129-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A216129-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A216129-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A216129-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A216129-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A216129-001AP1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216129-001AP1a50c72e98297…

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
49fc67d1-3b30-456b-951c-ca7f703432abAvailable 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
70756-611-25Ephedrine sulfate25 in 1 CARTONINJECTION254
70756-611-82Ephedrine sulfate1 mL in 1 VIAL, SINGLE-DOSEINJECTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70756-611-25ML - Milliliter70756-61110064b4f-2431-4ecd-802f-33df39b91fea12022-08-04
70756-611-82ML - Milliliter70756-6118005d5a4-51f9-4941-88d4-6e9d624f2da812022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-611EPHEDRINE SULFATE INJECTION [LIFESTAR PHARMA LLC]4Current NDC, Legacy NDC, 2 package rows20220424_49fc67d1-3b30-456b-951c-ca7f703432ab.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 RxLLCb6fc8311-7853-4666-a1c2-668a04fe21192026-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216129
application number: ANDA216129
Ephedrine sulfateEPHEDRINE SULFATEProPharma Distribution3843c820-f54b-5349-e063-6294a90a6b182025-07-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216129
application number: ANDA216129
Ephedrine sulfateEPHEDRINE SULFATEMedical Purchasing Solutions, LLC08f5ec19-7b53-681b-e063-6294a90acc862023-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216129
application number: ANDA216129
Ephedrine sulfateEPHEDRINE SULFATELifestar Pharma LLC49fc67d1-3b30-456b-951c-ca7f703432ab2022-04-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216129
application number: ANDA216129
ndc (product): 70756-611

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116294ePHEDrine sulfate 50 MG in 1 ML InjectionPSN49fc67d1-3b30-456b-951c-ca7f703432ab4
11162941 ML ephedrine sulfate 50 MG/ML InjectionSCD49fc67d1-3b30-456b-951c-ca7f703432ab4
1116294ephedrine sulfate 50 MG per 1 ML InjectionSY49fc67d1-3b30-456b-951c-ca7f703432ab4
1116294ePHEDrine sulfate 50 MG in 1 ML InjectionPSN3843c820-f54b-5349-e063-6294a90a6b183
11162941 ML ephedrine sulfate 50 MG/ML InjectionSCD3843c820-f54b-5349-e063-6294a90a6b183
1116294ephedrine sulfate 50 MG per 1 ML InjectionSY3843c820-f54b-5349-e063-6294a90a6b183
1116294ePHEDrine sulfate 50 MG in 1 ML InjectionPSN08f5ec19-7b53-681b-e063-6294a90acc861
11162941 ML ephedrine sulfate 50 MG/ML InjectionSCD08f5ec19-7b53-681b-e063-6294a90acc861
1116294ephedrine sulfate 50 MG per 1 ML InjectionSY08f5ec19-7b53-681b-e063-6294a90acc861

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70756-611-257075606112525 VIAL, SINGLE-DOSE in 1 CARTON (70756-611-25) / 1 mL in 1 VIAL, SINGLE-DOSE (70756-611-82) 2022-04-150000-00-00NoNoCurrent
70756-611-82707560611821 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical