Home NDC 68083-660 Selenious Acid
Product NDC 68083-660
11-digit product format 680830660
Labeler code 68083
Product ID 68083-660_32cdac6b-fccb-441e-87de-bcacc92c6998
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Selenious Acid
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Gland Pharma Limited
Application ANDA219629
Marketing category ANDA
Marketing start 2025-07-08
Substance SELENIUM
Active strength 60 ug/mL
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 A219629-001 SELENIOUS ACID SELENIOUS ACID EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) SOLUTION / INTRAVENOUS AP 2025-07-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219629-001 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 A219629-001 SELENIOUS ACID EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) SOLUTION / INTRAVENOUS AP 2025-07-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219629-001 SELENIOUS ACID EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) SOLUTION / INTRAVENOUS AP 2025-07-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219629-001 SELENIOUS ACID EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) SOLUTION / INTRAVENOUS AP 2025-07-08 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219629-001 SELENIOUS ACID EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) SOLUTION / INTRAVENOUS AP 2025-07-08 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 A219629-001 AP 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219629-001 AP 1 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219629-001 AP 1 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219629-001 AP 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Selenious Acid
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SELENIUM 60 ug/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination H6241UJ22B Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2176324 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 68083-660-05 Selenious Acid 05 in 1 BOX INJECTION, SOLUTION 05 3 68083-660-05 Selenious Acid 10 mL in 1 VIAL, PHARMACY BULK PACKAGE 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 · 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 68083-660-05 68083066005 5 VIAL, PHARMACY BULK PACKAGE in 1 BOX (68083-660-05) / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE 2025-07-08 No No Current