Kyzatrex

Product NDC: 80603-101
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	80603-101		D	Discontinued by firm	2026-10-15
excluded package	package	80603-101	80603-101-11	D	Discontinued by firm	2026-10-15
excluded package	package	80603-101	80603-101-22	D	Discontinued by firm	2026-10-15

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 · 3 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	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	80603-101		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80603-101	80603-101-11	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
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 44.

Orange Book products#

Current product rows page 1 of 1 · 4 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
N213953-004	KYZATREX	TESTOSTERONE UNDECANOATE	50MG	CAPSULE / ORAL	RLD	2026-08-25

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 · 92 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N213953-001	KYZATREX	100MG	CAPSULE / ORAL	RLD	2022-07-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213953-002	KYZATREX	150MG	CAPSULE / ORAL	RLD	2022-07-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213953-003	KYZATREX	200MG	CAPSULE / ORAL	RLD, RS	2022-07-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213953-004	KYZATREX	50MG	CAPSULE / ORAL	RLD	2026-08-25	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N213953-001	KYZATREX	100MG	CAPSULE / ORAL	RLD	2022-07-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213953-002	KYZATREX	150MG	CAPSULE / ORAL	RLD	2022-07-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213953-003	KYZATREX	200MG	CAPSULE / ORAL	RLD, RS	2022-07-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213953-004	KYZATREX	50MG	CAPSULE / ORAL	RLD	2026-08-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213953-001	KYZATREX	100MG	CAPSULE / ORAL	RLD	2022-07-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213953-002	KYZATREX	150MG	CAPSULE / ORAL	RLD	2022-07-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213953-003	KYZATREX	200MG	CAPSULE / ORAL	RLD, RS	2022-07-27	`caaa826d4ba7…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 10 · 366 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	N213953-001	10576089	2030-12-31	U-2506	Drug product	2022-08-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213953-001	10576090	2030-12-31		Drug product	2022-08-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213953-001	11590146	2030-12-31		Drug product	2023-05-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213953-001	11617758	2033-03-15	U-2506	Drug product	2023-05-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213953-001	12357643	2033-03-15	U-2506	Drug product	2025-08-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213953-001	12403146	2041-03-29	U-2506	Drug product	2025-10-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213953-002	10576089	2030-12-31	U-2506	Drug product	2022-08-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213953-002	10576090	2030-12-31		Drug product	2022-08-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213953-002	11590146	2030-12-31		Drug product	2023-05-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213953-002	11617758	2033-03-15	U-2506	Drug product	2023-05-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213953-002	12357643	2033-03-15	U-2506	Drug product	2025-08-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213953-002	12403146	2041-03-29	U-2506	Drug product	2025-10-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213953-003	10576089	2030-12-31	U-2506	Drug product	2022-08-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213953-003	10576090	2030-12-31		Drug product	2022-08-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213953-003	11590146	2030-12-31		Drug product	2023-05-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213953-003	11617758	2033-03-15	U-2506	Drug product	2023-05-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213953-003	12357643	2033-03-15	U-2506	Drug product	2025-08-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213953-003	12403146	2041-03-29	U-2506	Drug product	2025-10-03	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N213953-001	10576089	2030-12-31	U-2506	Drug product	2022-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213953-001	10576090	2030-12-31		Drug product	2022-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213953-001	11590146	2030-12-31		Drug product	2023-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213953-001	11617758	2033-03-15	U-2506	Drug product	2023-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213953-001	12357643	2033-03-15	U-2506	Drug product	2025-08-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213953-001	12403146	2041-03-29	U-2506	Drug product	2025-10-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213953-002	10576089	2030-12-31	U-2506	Drug product	2022-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213953-002	10576090	2030-12-31		Drug product	2022-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213953-002	11590146	2030-12-31		Drug product	2023-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213953-002	11617758	2033-03-15	U-2506	Drug product	2023-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213953-002	12357643	2033-03-15	U-2506	Drug product	2025-08-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213953-002	12403146	2041-03-29	U-2506	Drug product	2025-10-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213953-003	10576089	2030-12-31	U-2506	Drug product	2022-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213953-003	10576090	2030-12-31		Drug product	2022-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213953-003	11590146	2030-12-31		Drug product	2023-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213953-003	11617758	2033-03-15	U-2506	Drug product	2023-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213953-003	12357643	2033-03-15	U-2506	Drug product	2025-08-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213953-003	12403146	2041-03-29	U-2506	Drug product	2025-10-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213953-001	10576089	2030-12-31	U-2506	Drug product	2022-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213953-001	10576090	2030-12-31		Drug product	2022-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213953-001	11590146	2030-12-31		Drug product	2023-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213953-001	11617758	2033-03-15	U-2506	Drug product	2023-05-31	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 2 of 2 · 75 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213953-002	NP	2025-07-27	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213953-003	NP	2025-07-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213953-001	NP	2025-07-27	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N213953-002	NP	2025-07-27	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N213953-003	NP	2025-07-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213953-001	NP	2025-07-27	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N213953-002	NP	2025-07-27	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N213953-003	NP	2025-07-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213953-001	NP	2025-07-27	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213953-002	NP	2025-07-27	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213953-003	NP	2025-07-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213953-001	NP	2025-07-27	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213953-002	NP	2025-07-27	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213953-003	NP	2025-07-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213953-001	NP	2025-07-27	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213953-002	NP	2025-07-27	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213953-003	NP	2025-07-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213953-001	NP	2025-07-27	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213953-002	NP	2025-07-27	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213953-003	NP	2025-07-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213953-001	NP	2025-07-27	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N213953-002	NP	2025-07-27	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N213953-003	NP	2025-07-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213953-001	NP	2025-07-27	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N213953-002	NP	2025-07-27	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N213953-003	NP	2025-07-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213953-001	NP	2025-07-27	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213953-002	NP	2025-07-27	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213953-003	NP	2025-07-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213953-001	NP	2025-07-27	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N213953-002	NP	2025-07-27	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N213953-003	NP	2025-07-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213953-001	NP	2025-07-27	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N213953-002	NP	2025-07-27	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N213953-003	NP	2025-07-27	`e64feba35796…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

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
80603-101-11	80603010111	90 CAPSULE, LIQUID FILLED in 1 BOTTLE (80603-101-11)	2022-07-27	0000-00-00	No	No	Current
80603-101-22	80603010122	120 CAPSULE, LIQUID FILLED in 1 BOTTLE (80603-101-22)	2022-07-27	0000-00-00	No	No	Current