Home NDC 50742-539 Dehydrated Alcohol
Product NDC 50742-539
11-digit product format 507420539
Labeler code 50742
Product ID 50742-539_149c50c5-59ad-4602-ad9e-58ad960eb91d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dehydrated alcohol
Dosage form INJECTION, SOLUTION
Route PERCUTANEOUS
Labeler Ingenus Pharmaceuticals, LLC
Application ANDA219569
Marketing category ANDA
Marketing start 2025-07-09
Substance DEHYDRATED ALCOHOL
Active strength 5 mL/5mL
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 43 .
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 A219569-001 DEHYDRATED ALCOHOL DEHYDRATED ALCOHOL 99% (5ML) SOLUTION / INTRA-ARTERIAL AP 2025-07-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219569-001 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 2026-09-14 22:38:34 2026-08 A219569-001 DEHYDRATED ALCOHOL 99% (5ML) SOLUTION / INTRA-ARTERIAL AP 2025-07-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219569-001 DEHYDRATED ALCOHOL 99% (5ML) SOLUTION / INTRA-ARTERIAL AP 2025-07-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219569-001 DEHYDRATED ALCOHOL 99% (5ML) SOLUTION / INTRA-ARTERIAL AP 2025-07-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219569-001 DEHYDRATED ALCOHOL 99% (5ML) SOLUTION / INTRA-ARTERIAL AP 2025-07-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219569-001 DEHYDRATED ALCOHOL 99% (5ML) SOLUTION / INTRA-ARTERIAL AP 2025-07-09 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219569-001 DEHYDRATED ALCOHOL 99% (5ML) SOLUTION / INTRA-ARTERIAL AP 2025-07-09 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Dehydrated Alcohol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEHYDRATED ALCOHOL 5 mL/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3K9958V90M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2048982 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50742-539-01 Dehydrated Alcohol 5 mL in 1 VIAL, GLASS INJECTION, SOLUTION 5 3 50742-539-10 Dehydrated Alcohol 10 in 1 CARTON INJECTION, SOLUTION 10 3
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 · 3 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 50742-539-01 50742053901 5 mL in 1 VIAL, GLASS 5 ml Historical 50742-539-10 50742053910 10 VIAL, GLASS in 1 CARTON (50742-539-10) / 5 mL in 1 VIAL, GLASS (50742-539-01) 2025-07-09 No No Current