Selenious Acid

Product NDC: 0517-6560
Requested package NDC: 0517-6560-05
11-digit product format: 005176560
Labeler code: 0517
Product ID: 0517-6560_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: 2019-07-01
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 · 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.

Application-product, TE code table
Application-product	TE code
N209379-001	AP
N209379-002	AP
N209379-003	AP

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 · 109 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
2026-02-19 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…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209379-002	SELENIOUS ACID	EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-01-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209379-003	SELENIOUS ACID	EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-08-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209379-001	SELENIOUS ACID	EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209379-002	SELENIOUS ACID	EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-01-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209379-003	SELENIOUS ACID	EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-08-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209379-001	SELENIOUS ACID	EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209379-002	SELENIOUS ACID	EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-01-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209379-003	SELENIOUS ACID	EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-08-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209379-001	SELENIOUS ACID	EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-30	`8072bd15b7f6…`

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	N209379-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209379-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209379-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209379-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209379-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209379-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209379-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209379-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209379-002	AP	1	`b8a1b40f171c…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N209379-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N209379-002	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N209379-003	AP	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
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…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209379-003	11998565	2041-07-01		Drug product	2024-06-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209379-003	12150957	2041-07-01	U-4039		2024-12-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209379-001	11998565	2041-07-01		Drug product	2024-06-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209379-001	12150957	2041-07-01	U-4039		2024-12-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209379-002	11998565	2041-07-01		Drug product	2024-06-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209379-002	12150957	2041-07-01	U-4039		2024-12-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209379-003	11998565	2041-07-01		Drug product	2024-06-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209379-003	12150957	2041-07-01	U-4039		2024-12-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209379-001	11998565	2041-07-01		Drug product	2024-06-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209379-001	12150957	2041-07-01	U-4039		2024-12-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209379-002	11998565	2041-07-01		Drug product	2024-06-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209379-002	12150957	2041-07-01	U-4039		2024-12-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209379-003	11998565	2041-07-01		Drug product	2024-06-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209379-003	12150957	2041-07-01	U-4039		2024-12-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209379-001	11998565	2041-07-01		Drug product	2024-06-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209379-001	12150957	2041-07-01	U-4039		2024-12-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209379-002	11998565	2041-07-01		Drug product	2024-06-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209379-002	12150957	2041-07-01	U-4039		2024-12-03	`2680178bc6a6…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 89 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209379-001	NCE	2024-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209379-002	NCE	2024-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209379-003	NCE	2024-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209379-001	NCE	2024-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209379-002	NCE	2024-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209379-003	NCE	2024-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209379-001	NCE	2024-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209379-002	NCE	2024-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209379-003	NCE	2024-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209379-001	NCE	2024-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209379-002	NCE	2024-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209379-003	NCE	2024-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209379-001	NCE	2024-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209379-002	NCE	2024-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209379-003	NCE	2024-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209379-001	NCE	2024-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209379-002	NCE	2024-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209379-003	NCE	2024-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209379-001	NCE	2024-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209379-002	NCE	2024-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209379-003	NCE	2024-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209379-001	NCE	2024-04-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209379-002	NCE	2024-04-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209379-003	NCE	2024-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209379-001	NCE	2024-04-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209379-002	NCE	2024-04-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209379-003	NCE	2024-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209379-001	NCE	2024-04-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209379-002	NCE	2024-04-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209379-003	NCE	2024-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209379-001	NCE	2024-04-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209379-002	NCE	2024-04-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209379-003	NCE	2024-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209379-001	NCE	2024-04-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209379-002	NCE	2024-04-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209379-003	NCE	2024-04-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209379-001	NCE	2024-04-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209379-001	NCE	2024-04-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209379-002	NCE	2024-04-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209379-003	NCE	2024-04-30	`bb7c543d1eb4…`

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 · 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
49324999-50e3-43ed-a8dd-156d6dbedd9f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
86fffa7b-d382-4771-a253-25cccb64b590	Product name	3	20251124
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0517-6560-01	Selenious Acid	10 mL in 1 VIAL, PHARMACY BULK PACKAGE	INJECTION, SOLUTION	10		13
0517-6560-05	Selenious Acid	5 in 1 BOX	INJECTION, SOLUTION	5		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0517-6560-01	ML - Milliliter	0517-6560	0388efec-a68b-42db-92aa-7f6d54639093	1	2019-07-02
0517-6560-05	ML - Milliliter	0517-6560	25ccfe24-7faf-4de3-9c3a-d4196b911cb8	1	2019-11-12
0517-6560-25	ML - Milliliter	0517-6560	652d9735-2973-4fa2-a64c-27ca425f3c89	1	2019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0517-6560	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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Selenious Acid	SELENIOUS ACID	American Regent, Inc.	49324999-50e3-43ed-a8dd-156d6dbedd9f	2021-08-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209379 application number: NDA209379 ndc (package): 0517-6560-05 ndc (product): 0517-6560 ndc11 (package): 00517656005

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
H6241UJ22B	SELENIUM	7782-49-2	SELENIUM
F6A27P4Q4R	SELENIOUS ACID	7783-00-8	Selenious Acid

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2591522	selenium 12 MCG in 2 ML Injection	PSN	49324999-50e3-43ed-a8dd-156d6dbedd9f	13
2176324	selenium 60 MCG/mL Injectable Solution	PSN	49324999-50e3-43ed-a8dd-156d6dbedd9f	13
2591522	2 ML selenious acid 0.0098 MG/ML Injection	SCD	49324999-50e3-43ed-a8dd-156d6dbedd9f	13
2176324	selenious acid 0.098 MG/ML Injectable Solution	SCD	49324999-50e3-43ed-a8dd-156d6dbedd9f	13
2591522	selenious acid 9.8 MCG/ML per 2 ML Injection	SY	49324999-50e3-43ed-a8dd-156d6dbedd9f	13
2591522	selenium 12 MCG per 2 ML Injection	SY	49324999-50e3-43ed-a8dd-156d6dbedd9f	13
2591522	selenium 6 MCG/ML per 2 ML Injection	SY	49324999-50e3-43ed-a8dd-156d6dbedd9f	13
2176324	selenium 60 MCG/ML Injectable Solution	SY	49324999-50e3-43ed-a8dd-156d6dbedd9f	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0517-6560-05	00517656005	5 VIAL, PHARMACY BULK PACKAGE in 1 BOX (0517-6560-05) / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE (0517-6560-01)	2019-07-01	0000-00-00	No	No	Current