Kyzatrex

Product NDC: 80603-101
Requested package NDC: 80603-101-22
11-digit product format: 806030101
Labeler code: 80603
Product ID: 80603-101_eb4f7d4f-fcb5-e4aa-e053-2a95a90abe97
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TESTOSTERONE UNDECANOATE
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Marius Pharmaceuticals
Application: NDA213953
Marketing category: NDA
Marketing start: 2022-07-27
Marketing end: 0000-00-00
Substance: TESTOSTERONE UNDECANOATE
Active strength: 100 mg/1
Pharmacologic classes: Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
DEA schedule: CIII
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	80603-101	80603-101-22	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80603-101	80603-101-22	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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	RLD / RS	Approval date
N213953-001	KYZATREX	TESTOSTERONE UNDECANOATE	100MG	CAPSULE / ORAL	RLD	2022-07-27
N213953-002	KYZATREX	TESTOSTERONE UNDECANOATE	150MG	CAPSULE / ORAL	RLD	2022-07-27
N213953-003	KYZATREX	TESTOSTERONE UNDECANOATE	200MG	CAPSULE / ORAL	RLD, RS	2022-07-27

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213953-001	10576089	2030-12-31	U-2506	Drug product	2022-08-26
N213953-001	10576090	2030-12-31		Drug product	2022-08-26
N213953-001	11590146	2030-12-31		Drug product	2023-05-31
N213953-001	11617758	2033-03-15	U-2506	Drug product	2023-05-31
N213953-001	12357643	2033-03-15	U-2506	Drug product	2025-08-13
N213953-001	12403146	2041-03-29	U-2506	Drug product	2025-10-03
N213953-002	10576089	2030-12-31	U-2506	Drug product	2022-08-26
N213953-002	10576090	2030-12-31		Drug product	2022-08-26
N213953-002	11590146	2030-12-31		Drug product	2023-05-31
N213953-002	11617758	2033-03-15	U-2506	Drug product	2023-05-31
N213953-002	12357643	2033-03-15	U-2506	Drug product	2025-08-13
N213953-002	12403146	2041-03-29	U-2506	Drug product	2025-10-03
N213953-003	10576089	2030-12-31	U-2506	Drug product	2022-08-26
N213953-003	10576090	2030-12-31		Drug product	2022-08-26
N213953-003	11590146	2030-12-31		Drug product	2023-05-31
N213953-003	11617758	2033-03-15	U-2506	Drug product	2023-05-31
N213953-003	12357643	2033-03-15	U-2506	Drug product	2025-08-13
N213953-003	12403146	2041-03-29	U-2506	Drug product	2025-10-03

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 · 81 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N213953-001	KYZATREX	100MG	CAPSULE / ORAL	RLD	2022-07-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213953-002	KYZATREX	150MG	CAPSULE / ORAL	RLD	2022-07-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213953-003	KYZATREX	200MG	CAPSULE / ORAL	RLD, RS	2022-07-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-001	KYZATREX	100MG	CAPSULE / ORAL	RLD	2022-07-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-002	KYZATREX	150MG	CAPSULE / ORAL	RLD	2022-07-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-003	KYZATREX	200MG	CAPSULE / ORAL	RLD, RS	2022-07-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213953-001	KYZATREX	100MG	CAPSULE / ORAL	RLD	2022-07-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213953-002	KYZATREX	150MG	CAPSULE / ORAL	RLD	2022-07-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213953-003	KYZATREX	200MG	CAPSULE / ORAL	RLD, RS	2022-07-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213953-001	KYZATREX	100MG	CAPSULE / ORAL	RLD	2022-07-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213953-002	KYZATREX	150MG	CAPSULE / ORAL	RLD	2022-07-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213953-003	KYZATREX	200MG	CAPSULE / ORAL	RLD, RS	2022-07-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213953-001	KYZATREX	100MG	CAPSULE / ORAL	RLD	2022-07-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213953-002	KYZATREX	150MG	CAPSULE / ORAL	RLD	2022-07-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213953-003	KYZATREX	200MG	CAPSULE / ORAL	RLD, RS	2022-07-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213953-001	KYZATREX	100MG	CAPSULE / ORAL	RLD	2022-07-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213953-002	KYZATREX	150MG	CAPSULE / ORAL	RLD	2022-07-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213953-003	KYZATREX	200MG	CAPSULE / ORAL	RLD, RS	2022-07-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213953-001	KYZATREX	100MG	CAPSULE / ORAL	RLD	2022-07-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213953-002	KYZATREX	150MG	CAPSULE / ORAL	RLD	2022-07-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213953-003	KYZATREX	200MG	CAPSULE / ORAL	RLD, RS	2022-07-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213953-001	KYZATREX	100MG	CAPSULE / ORAL	RLD	2022-07-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213953-002	KYZATREX	150MG	CAPSULE / ORAL	RLD	2022-07-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213953-003	KYZATREX	200MG	CAPSULE / ORAL	RLD, RS	2022-07-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213953-001	KYZATREX	100MG	CAPSULE / ORAL	RLD	2022-07-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213953-002	KYZATREX	150MG	CAPSULE / ORAL	RLD	2022-07-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213953-003	KYZATREX	200MG	CAPSULE / ORAL	RLD, RS	2022-07-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213953-001	KYZATREX	100MG	CAPSULE / ORAL	RLD	2022-07-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213953-002	KYZATREX	150MG	CAPSULE / ORAL	RLD	2022-07-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213953-003	KYZATREX	200MG	CAPSULE / ORAL	RLD, RS	2022-07-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213953-001	KYZATREX	100MG	CAPSULE / ORAL	RLD	2022-07-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213953-002	KYZATREX	150MG	CAPSULE / ORAL	RLD	2022-07-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213953-003	KYZATREX	200MG	CAPSULE / ORAL	RLD, RS	2022-07-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213953-001	KYZATREX	100MG	CAPSULE / ORAL	RLD	2022-07-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213953-002	KYZATREX	150MG	CAPSULE / ORAL	RLD	2022-07-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213953-003	KYZATREX	200MG	CAPSULE / ORAL	RLD, RS	2022-07-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213953-001	KYZATREX	100MG	CAPSULE / ORAL	RLD	2022-07-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213953-002	KYZATREX	150MG	CAPSULE / ORAL	RLD	2022-07-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213953-003	KYZATREX	200MG	CAPSULE / ORAL	RLD, RS	2022-07-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213953-001	KYZATREX	100MG	CAPSULE / ORAL	RLD	2022-07-27	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 312 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	N213953-001	10576089	2030-12-31	U-2506	Drug product	2022-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213953-001	10576090	2030-12-31		Drug product	2022-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213953-001	11590146	2030-12-31		Drug product	2023-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213953-001	11617758	2033-03-15	U-2506	Drug product	2023-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213953-001	12357643	2033-03-15	U-2506	Drug product	2025-08-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213953-001	12403146	2041-03-29	U-2506	Drug product	2025-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213953-002	10576089	2030-12-31	U-2506	Drug product	2022-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213953-002	10576090	2030-12-31		Drug product	2022-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213953-002	11590146	2030-12-31		Drug product	2023-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213953-002	11617758	2033-03-15	U-2506	Drug product	2023-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213953-002	12357643	2033-03-15	U-2506	Drug product	2025-08-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213953-002	12403146	2041-03-29	U-2506	Drug product	2025-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213953-003	10576089	2030-12-31	U-2506	Drug product	2022-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213953-003	10576090	2030-12-31		Drug product	2022-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213953-003	11590146	2030-12-31		Drug product	2023-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213953-003	11617758	2033-03-15	U-2506	Drug product	2023-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213953-003	12357643	2033-03-15	U-2506	Drug product	2025-08-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213953-003	12403146	2041-03-29	U-2506	Drug product	2025-10-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-001	10576089	2030-12-31	U-2506	Drug product	2022-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-001	10576090	2030-12-31		Drug product	2022-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-001	11590146	2030-12-31		Drug product	2023-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-001	11617758	2033-03-15	U-2506	Drug product	2023-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-001	12357643	2033-03-15	U-2506	Drug product	2025-08-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-001	12403146	2041-03-29	U-2506	Drug product	2025-10-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-002	10576089	2030-12-31	U-2506	Drug product	2022-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-002	10576090	2030-12-31		Drug product	2022-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-002	11590146	2030-12-31		Drug product	2023-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-002	11617758	2033-03-15	U-2506	Drug product	2023-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-002	12357643	2033-03-15	U-2506	Drug product	2025-08-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-002	12403146	2041-03-29	U-2506	Drug product	2025-10-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-003	10576089	2030-12-31	U-2506	Drug product	2022-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-003	10576090	2030-12-31		Drug product	2022-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-003	11590146	2030-12-31		Drug product	2023-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-003	11617758	2033-03-15	U-2506	Drug product	2023-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-003	12357643	2033-03-15	U-2506	Drug product	2025-08-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-003	12403146	2041-03-29	U-2506	Drug product	2025-10-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213953-001	10576089	2030-12-31	U-2506	Drug product	2022-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213953-001	10576090	2030-12-31		Drug product	2022-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213953-001	11590146	2030-12-31		Drug product	2023-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213953-001	11617758	2033-03-15	U-2506	Drug product	2023-05-31	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 75 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-001	NP	2025-07-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-002	NP	2025-07-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213953-003	NP	2025-07-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213953-001	NP	2025-07-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213953-002	NP	2025-07-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213953-003	NP	2025-07-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213953-001	NP	2025-07-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213953-002	NP	2025-07-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213953-003	NP	2025-07-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213953-001	NP	2025-07-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213953-002	NP	2025-07-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213953-003	NP	2025-07-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213953-001	NP	2025-07-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213953-002	NP	2025-07-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213953-003	NP	2025-07-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213953-001	NP	2025-07-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213953-002	NP	2025-07-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213953-003	NP	2025-07-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213953-001	NP	2025-07-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213953-002	NP	2025-07-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213953-003	NP	2025-07-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213953-001	NP	2025-07-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213953-002	NP	2025-07-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213953-003	NP	2025-07-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213953-001	NP	2025-07-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213953-002	NP	2025-07-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213953-003	NP	2025-07-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213953-001	NP	2025-07-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213953-002	NP	2025-07-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213953-003	NP	2025-07-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213953-001	NP	2025-07-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213953-002	NP	2025-07-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213953-003	NP	2025-07-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213953-001	NP	2025-07-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213953-002	NP	2025-07-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213953-003	NP	2025-07-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213953-001	NP	2025-07-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N213953-002	NP	2025-07-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N213953-003	NP	2025-07-27	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213953-001	NP	2025-07-27	`6a51e52b5d6a…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2db4fc38-a116-b0ab-3dae-57df54e5f212	Product name	2	20250121
386d1b2a-e9b7-0c83-111f-2a77b92895b3	Product name	5	20240422
7d55b53c-798b-47ae-992b-3921493a8303	Product name	1	20230322
8d753fd6-75b2-4f12-bcbf-339392960afa	Product name	1	20230303
4fbda828-a5be-46fe-83ec-a88da4359919	Product name	1	20230104
93cc9bee-8bdc-273d-ec7f-c2c52535317a	Product name	7	20210902
a6389cd1-36d1-4b5c-9934-1139bee93605	Product name	5	20210601
f4f0889f-ee8b-471f-9a37-02a035280637	Product name	1	20200122
09e1afd3-f431-4380-82c5-438884c25615	Product name	1	20190111
a6389cd1-36d1-4b5c-9934-1139bee93605	Product name	3	20171212
502efed8-01a5-ef6a-61c6-fe8302b6e26b	Product name	2	20171113
8b700cfd-17dd-41a2-90f5-a80ae8a989a2	Product name	1	20171113
9ce0e503-4ae7-2c6a-39ae-85285c29db68	Product name	2	20171113
96bdf4b3-71cd-433d-9723-89e50f852992	Product name	1	20150810
ed2e617f-f28a-1df1-f9fc-c79702f31271	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80603-101-11	Kyzatrex	90 in 1 BOTTLE	CAPSULE, LIQUID FILLED	90		22
80603-101-22	Kyzatrex	120 in 1 BOTTLE	CAPSULE, LIQUID FILLED	120		22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80603-101-22	EA - Each	80603-101	8f1fd811-b4d2-41a5-b91a-9dcc2a7a63fe	1	2022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80603-101	KYZATREX (TESTOSTERONE UNDECANOATE) CAPSULE, LIQUID FILLED [MARIUS PHARMACEUTICALS]	15	Legacy NDC, 2 package rows	20231027_7f7167a7-2a25-47e2-acf5-33f499fce971.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
Kyzatrex	TESTOSTERONE UNDECANOATE	Marius Pharmaceuticals	7f7167a7-2a25-47e2-acf5-33f499fce971	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213953 application number: NDA213953 ndc (package): 80603-101-22 ndc (product): 80603-101 ndc11 (package): 80603010122

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
H16A5VCT9C	TESTOSTERONE UNDECANOATE	5949-44-0	TESTOSTERONE UNDECANOATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2609603	KYZATREX 100 MG Oral Capsule	PSN	7f7167a7-2a25-47e2-acf5-33f499fce971	22
2609607	KYZATREX 150 MG Oral Capsule	PSN	7f7167a7-2a25-47e2-acf5-33f499fce971	22
2609611	KYZATREX 200 MG Oral Capsule	PSN	7f7167a7-2a25-47e2-acf5-33f499fce971	22
2609597	testosterone undecanoate 100 MG Oral Capsule	PSN	7f7167a7-2a25-47e2-acf5-33f499fce971	22
2609605	testosterone undecanoate 150 MG Oral Capsule	PSN	7f7167a7-2a25-47e2-acf5-33f499fce971	22
2609609	testosterone undecanoate 200 MG Oral Capsule	PSN	7f7167a7-2a25-47e2-acf5-33f499fce971	22
2609603	testosterone undecanoate 100 MG Oral Capsule [Kyzatrex]	SBD	7f7167a7-2a25-47e2-acf5-33f499fce971	22
2609607	testosterone undecanoate 150 MG Oral Capsule [Kyzatrex]	SBD	7f7167a7-2a25-47e2-acf5-33f499fce971	22
2609611	testosterone undecanoate 200 MG Oral Capsule [Kyzatrex]	SBD	7f7167a7-2a25-47e2-acf5-33f499fce971	22
2609597	testosterone undecanoate 100 MG Oral Capsule	SCD	7f7167a7-2a25-47e2-acf5-33f499fce971	22
2609605	testosterone undecanoate 150 MG Oral Capsule	SCD	7f7167a7-2a25-47e2-acf5-33f499fce971	22
2609609	testosterone undecanoate 200 MG Oral Capsule	SCD	7f7167a7-2a25-47e2-acf5-33f499fce971	22
2609603	Kyzatrex 100 MG Oral Capsule	SY	7f7167a7-2a25-47e2-acf5-33f499fce971	22
2609607	Kyzatrex 150 MG Oral Capsule	SY	7f7167a7-2a25-47e2-acf5-33f499fce971	22
2609611	Kyzatrex 200 MG Oral Capsule	SY	7f7167a7-2a25-47e2-acf5-33f499fce971	22

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
80603-101-22	80603010122	120 CAPSULE, LIQUID FILLED in 1 BOTTLE (80603-101-22)	2022-07-27	0000-00-00	No	No	Current