Home NDC 68083-610 Ephedrine Sulfate
Product NDC 68083-610
11-digit product format 680830610
Labeler code 68083
Product ID 68083-610_f743e5f5-b2bb-424d-887f-9ea5ec06ea92
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ephedrine Sulfate
Dosage form INJECTION
Route INTRAVENOUS
Labeler Gland Pharma Limited
Application ANDA218211
Marketing category ANDA
Marketing start 2025-01-16
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 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 A218211-001 EPHEDRINE SULFATE EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP1 2025-01-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218211-001 AP1
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 RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A218211-001 EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP1 2025-01-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218211-001 EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP1 2025-01-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218211-001 EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP1 2025-01-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218211-001 EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2025-01-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218211-001 EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2025-01-16 b8a1b40f171c…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218211-001 EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP1 2025-01-16 a50c72e98297…
Observed Orange Book normalized TE history# 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 5 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 2368456 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68083-610-10 Ephedrine Sulfate 10 in 1 CARTON INJECTION 10 3 68083-610-10 Ephedrine Sulfate 10 mL in 1 VIAL INJECTION 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-610 EPHEDRINE SULFATE INJECTION [GLAND PHARMA LIMITED] 3 Current NDC, 2 package rows 20250121_523ec357-7fdb-482d-85f1-acb3b25eb764.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68083-610-10 68083061010 10 VIAL in 1 CARTON (68083-610-10) / 10 mL in 1 VIAL 10 vial 2025-01-16 No No Current