Home NDC 0517-6502 Selenious Acid
Product NDC 0517-6502
11-digit product format 005176502
Labeler code 0517
Product ID 0517-6502_4f6657ea-8dfd-4a74-8a36-9855ca7fd34a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Selenious Acid
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler American Regent, Inc.
Application NDA209379
Marketing category NDA
Marketing start 2022-03-28
Substance SELENIUM
Active strength 6 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 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N209379-001 SELENIOUS ACID SELENIOUS ACID EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-04-30 N209379-002 SELENIOUS ACID SELENIOUS ACID EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2021-01-25 N209379-003 SELENIOUS ACID SELENIOUS ACID EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2021-08-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209379-001 11998565 2041-07-01 Drug product 2024-06-07 N209379-001 12150957 2041-07-01 U-4039 2024-12-03 N209379-002 11998565 2041-07-01 Drug product 2024-06-07 N209379-002 12150957 2041-07-01 U-4039 2024-12-03 N209379-003 11998565 2041-07-01 Drug product 2024-06-07 N209379-003 12150957 2041-07-01 U-4039 2024-12-03
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.
Product history page 1 of 3 · 118 observed 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 2026-10-15 13:18:30 2026-09 N209379-001 SELENIOUS ACID EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-04-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209379-002 SELENIOUS ACID EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2021-01-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209379-003 SELENIOUS ACID EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2021-08-30 c2088c7a36db…2026-09-14 22:38:34 2026-08 N209379-001 SELENIOUS ACID EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-04-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209379-002 SELENIOUS ACID EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2021-01-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209379-003 SELENIOUS ACID EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2021-08-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 N209379-001 SELENIOUS ACID EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-04-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209379-002 SELENIOUS ACID EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2021-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209379-003 SELENIOUS ACID EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2021-08-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209379-001 SELENIOUS ACID EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209379-002 SELENIOUS ACID EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2021-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209379-003 SELENIOUS ACID EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2021-08-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209379-001 SELENIOUS ACID EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209379-002 SELENIOUS ACID EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-01-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209379-003 SELENIOUS ACID EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2021-08-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209379-001 SELENIOUS ACID EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209379-002 SELENIOUS ACID EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-01-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209379-003 SELENIOUS ACID EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2021-08-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209379-001 SELENIOUS ACID EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-04-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209379-002 SELENIOUS ACID EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-01-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209379-003 SELENIOUS ACID EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209379-001 SELENIOUS ACID EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-04-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209379-002 SELENIOUS ACID EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2021-01-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209379-003 SELENIOUS ACID EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209379-001 SELENIOUS ACID EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-04-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209379-002 SELENIOUS ACID EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-01-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209379-003 SELENIOUS ACID EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209379-001 SELENIOUS ACID EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-04-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209379-002 SELENIOUS ACID EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-01-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209379-003 SELENIOUS ACID EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209379-001 SELENIOUS ACID EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-04-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209379-002 SELENIOUS ACID EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-01-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209379-003 SELENIOUS ACID EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209379-001 SELENIOUS ACID EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-04-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209379-002 SELENIOUS ACID EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-01-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209379-003 SELENIOUS ACID EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209379-001 SELENIOUS ACID EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-04-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N209379-002 SELENIOUS ACID EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-01-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N209379-003 SELENIOUS ACID EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209379-001 SELENIOUS ACID EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-04-30 79d66fd596c7…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N209379-001 11998565 2041-07-01 Drug product 2024-06-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209379-001 12150957 2041-07-01 U-4039 2024-12-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209379-002 11998565 2041-07-01 Drug product 2024-06-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209379-002 12150957 2041-07-01 U-4039 2024-12-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209379-003 11998565 2041-07-01 Drug product 2024-06-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209379-003 12150957 2041-07-01 U-4039 2024-12-03 c2088c7a36db…2026-09-14 22:38:34 2026-08 N209379-001 11998565 2041-07-01 Drug product 2024-06-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209379-001 12150957 2041-07-01 U-4039 2024-12-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209379-002 11998565 2041-07-01 Drug product 2024-06-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209379-002 12150957 2041-07-01 U-4039 2024-12-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209379-003 11998565 2041-07-01 Drug product 2024-06-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209379-003 12150957 2041-07-01 U-4039 2024-12-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 N209379-001 11998565 2041-07-01 Drug product 2024-06-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209379-001 12150957 2041-07-01 U-4039 2024-12-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209379-002 11998565 2041-07-01 Drug product 2024-06-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209379-002 12150957 2041-07-01 U-4039 2024-12-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209379-003 11998565 2041-07-01 Drug product 2024-06-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209379-003 12150957 2041-07-01 U-4039 2024-12-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209379-001 11998565 2041-07-01 Drug product 2024-06-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209379-001 12150957 2041-07-01 U-4039 2024-12-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209379-002 11998565 2041-07-01 Drug product 2024-06-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209379-002 12150957 2041-07-01 U-4039 2024-12-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209379-003 11998565 2041-07-01 Drug product 2024-06-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209379-003 12150957 2041-07-01 U-4039 2024-12-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209379-001 11998565 2041-07-01 Drug product 2024-06-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209379-001 12150957 2041-07-01 U-4039 2024-12-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209379-002 11998565 2041-07-01 Drug product 2024-06-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209379-002 12150957 2041-07-01 U-4039 2024-12-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209379-003 11998565 2041-07-01 Drug product 2024-06-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209379-003 12150957 2041-07-01 U-4039 2024-12-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209379-001 11998565 2041-07-01 Drug product 2024-06-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209379-001 12150957 2041-07-01 U-4039 2024-12-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209379-002 11998565 2041-07-01 Drug product 2024-06-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209379-002 12150957 2041-07-01 U-4039 2024-12-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209379-003 11998565 2041-07-01 Drug product 2024-06-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209379-003 12150957 2041-07-01 U-4039 2024-12-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209379-001 11998565 2041-07-01 Drug product 2024-06-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209379-001 12150957 2041-07-01 U-4039 2024-12-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209379-002 11998565 2041-07-01 Drug product 2024-06-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209379-002 12150957 2041-07-01 U-4039 2024-12-03 fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 89 observed states.
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 Selenious Acid
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SELENIUM 6 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2176324 Internal RxNorm lookup 2591522 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 0517-6502-01 Selenious Acid 2 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 2 13 0517-6502-10 Selenious Acid 10 in 1 BOX INJECTION, SOLUTION 10 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0517-6502 SELENIOUS ACID INJECTION, SOLUTION [AMERICAN REGENT, INC.] 13 Current NDC, Legacy NDC, 2 package rows 20240112_49324999-50e3-43ed-a8dd-156d6dbedd9f.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 0517-6502-01 00517650201 2 mL in 1 VIAL, SINGLE-DOSE 2 ml Historical 0517-6502-10 00517650210 10 VIAL, SINGLE-DOSE in 1 BOX (0517-6502-10) / 2 mL in 1 VIAL, SINGLE-DOSE (0517-6502-01) 2022-03-28 0000-00-00 No No Current