Home NDC 0641-6238 Ephedrine Sulfate
Product NDC 0641-6238
11-digit product format 006416238
Labeler code 0641
Product ID 0641-6238_355370f0-4f22-42cf-92c4-fda0763ccc2e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ephedrine Sulfate
Dosage form INJECTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA214334
Marketing category ANDA
Marketing start 2020-12-15
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 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 A214334-001 EPHEDRINE SULFATE EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2020-12-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214334-001 AP
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 A214334-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2020-12-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214334-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2020-12-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214334-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2020-12-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214334-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2020-12-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214334-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2020-12-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214334-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2020-12-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214334-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2020-12-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214334-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2020-12-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214334-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2020-12-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214334-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2020-12-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214334-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2020-12-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214334-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2020-12-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214334-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2020-12-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214334-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2020-12-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214334-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2020-12-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A214334-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2020-12-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A214334-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2020-12-15 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A214334-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2020-12-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A214334-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2020-12-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A214334-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2020-12-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A214334-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2020-12-15 5aa47cf7b7d7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214334-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2020-12-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214334-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2020-12-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214334-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2020-12-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214334-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2020-12-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214334-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2020-12-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214334-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2020-12-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214334-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2020-12-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214334-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2020-12-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214334-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2020-12-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214334-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2020-12-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214334-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2020-12-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214334-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2020-12-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A214334-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2020-12-15 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214334-001 EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP 2020-12-15 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 50 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 1116294 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 0641-6238-01 Ephedrine Sulfate 1 mL in 1 VIAL, SINGLE-DOSE INJECTION 1 2 0641-6238-25 Ephedrine Sulfate 25 in 1 CARTON INJECTION 25 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0641-6238 EPHEDRINE SULFATE INJECTION [HIKMA PHARMACEUTICALS USA INC.] 2 Current NDC, Legacy NDC, 2 package rows 20240411_794cb942-04e3-4472-8eb8-92613329e4d5.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 Marketing end Sample Exclude flag Status 0641-6238-01 00641623801 1 mL in 1 VIAL, SINGLE-DOSE 1 ml Historical 0641-6238-25 00641623825 25 VIAL, SINGLE-DOSE in 1 CARTON (0641-6238-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0641-6238-01) 2020-12-15 0000-00-00 No No Current