Home NDC 0641-6236 Ephedrine Sulfate
Product NDC 0641-6236
11-digit product format 006416236
Labeler code 0641
Product ID 0641-6236_2d36e5ea-35a6-467b-860c-2b1b136bb0f8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ephedrine Sulfate
Dosage form INJECTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA217721
Marketing category ANDA
Marketing start 2024-12-20
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 A217721-001 EPHEDRINE SULFATE EPHEDRINE SULFATE 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS AP3 2024-10-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217721-001 AP3
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 A217721-001 EPHEDRINE SULFATE 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS AP3 2024-10-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217721-001 EPHEDRINE SULFATE 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS AP3 2024-10-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217721-001 EPHEDRINE SULFATE 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS AP3 2024-10-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217721-001 EPHEDRINE SULFATE 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2024-10-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217721-001 EPHEDRINE SULFATE 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2024-10-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217721-001 EPHEDRINE SULFATE 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2024-10-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217721-001 EPHEDRINE SULFATE 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2024-10-11 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217721-001 EPHEDRINE SULFATE 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2024-10-11 d8e5a09893c0…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217721-001 EPHEDRINE SULFATE 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS AP3 2024-10-11 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217721-001 CGT 2025-06-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217721-001 CGT 2025-06-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217721-001 CGT 2025-06-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217721-001 CGT 2025-06-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217721-001 CGT 2025-06-18 03ed91905a0d…
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 2586841 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 0641-6236-10 Ephedrine Sulfate 10 in 1 CARTON INJECTION 10 4 0641-6236-10 Ephedrine Sulfate 5 mL in 1 SYRINGE, PLASTIC INJECTION 5 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0641-6236 EPHEDRINE SULFATE INJECTION [HIKMA PHARMACEUTICALS USA INC.] 4 Current NDC, 2 package rows 20241222_24787cb1-23e8-4baa-9838-a31a466b8c79.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 Marketing start Sample Exclude flag Status 0641-6236-10 00641623610 10 SYRINGE, PLASTIC in 1 CARTON (0641-6236-10) / 5 mL in 1 SYRINGE, PLASTIC 2024-12-20 No No Current