Jatenzo

Product NDC: 69087-198
11-digit product format: 690870198
Labeler code: 69087
Product ID: 69087-198_b62fac0e-07df-453f-b56a-bd94e5ee3336
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: testosterone undecanoate
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: TOLMAR Inc.
Application: NDA206089
Marketing category: NDA
Marketing start: 2019-08-01
Substance: TESTOSTERONE UNDECANOATE
Active strength: 198 mg/1
Pharmacologic classes: Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
DEA schedule: CIII
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	RLD / RS	Approval date
N206089-001	JATENZO	TESTOSTERONE UNDECANOATE	158MG	CAPSULE / ORAL	RLD	2019-03-27
N206089-002	JATENZO	TESTOSTERONE UNDECANOATE	198MG	CAPSULE / ORAL	RLD	2019-03-27
N206089-003	JATENZO	TESTOSTERONE UNDECANOATE	237MG	CAPSULE / ORAL	RLD, RS	2019-03-27

Orange Book patents#

Current patent rows page 1 of 1 · 33 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N206089-001	11179402	2026-04-14		Drug substance, Drug product	2021-12-21
N206089-001	11331325	2027-01-06	U-2506		2022-06-02
N206089-001	8241664	2029-03-29	U-2506	Drug product	2019-04-08
N206089-001	10543219	2030-04-12	U-2506		2020-02-18
N206089-001	10617696	2030-04-12		Drug substance, Drug product	2020-05-05
N206089-001	11179403	2030-04-12	U-2506		2021-12-21
N206089-001	11426416	2030-04-12	U-3420		2022-09-12
N206089-001	8778916	2030-04-12		Drug product	2019-04-08
N206089-001	8492369	2030-12-20	U-2506	Drug product	2019-04-08
N206089-001	11564933	2039-04-12	U-1103		2023-02-10
N206089-001	12605391	2039-04-12	U-1103		2026-04-24
N206089-002	11179402	2026-04-14		Drug substance, Drug product	2021-12-21
N206089-002	11331325	2027-01-06	U-2506		2022-06-02
N206089-002	8241664	2029-03-29	U-2506	Drug product	2019-04-08
N206089-002	10543219	2030-04-12	U-2506		2020-02-18
N206089-002	10617696	2030-04-12		Drug substance, Drug product	2020-05-05
N206089-002	11179403	2030-04-12	U-2506		2021-12-21
N206089-002	11426416	2030-04-12	U-3420		2022-09-12
N206089-002	8778916	2030-04-12		Drug product	2019-04-08
N206089-002	8492369	2030-12-20	U-2506	Drug product	2019-04-08
N206089-002	11564933	2039-04-12	U-1103		2023-02-10
N206089-002	12605391	2039-04-12	U-1103		2026-04-24
N206089-003	11179402	2026-04-14		Drug substance, Drug product	2021-12-21
N206089-003	11331325	2027-01-06	U-2506		2022-06-02
N206089-003	8241664	2029-03-29	U-2506	Drug product	2019-04-08
N206089-003	10543219	2030-04-12	U-2506		2020-02-18
N206089-003	10617696	2030-04-12		Drug substance, Drug product	2020-05-05
N206089-003	11179403	2030-04-12	U-2506		2021-12-21
N206089-003	11426416	2030-04-12	U-3420		2022-09-12
N206089-003	8778916	2030-04-12		Drug product	2019-04-08
N206089-003	8492369	2030-12-20	U-2506	Drug product	2019-04-08
N206089-003	11564933	2039-04-12	U-1103		2023-02-10
N206089-003	12605391	2039-04-12	U-1103		2026-04-24

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 4 · 123 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	N206089-001	JATENZO	158MG	CAPSULE / ORAL	RLD	2019-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-002	JATENZO	198MG	CAPSULE / ORAL	RLD	2019-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-003	JATENZO	237MG	CAPSULE / ORAL	RLD, RS	2019-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206089-001	JATENZO	158MG	CAPSULE / ORAL	RLD	2019-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206089-002	JATENZO	198MG	CAPSULE / ORAL	RLD	2019-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206089-003	JATENZO	237MG	CAPSULE / ORAL	RLD, RS	2019-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206089-001	JATENZO	158MG	CAPSULE / ORAL	RLD	2019-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206089-002	JATENZO	198MG	CAPSULE / ORAL	RLD	2019-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206089-003	JATENZO	237MG	CAPSULE / ORAL	RLD, RS	2019-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206089-001	JATENZO	158MG	CAPSULE / ORAL	RLD	2019-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206089-002	JATENZO	198MG	CAPSULE / ORAL	RLD	2019-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206089-003	JATENZO	237MG	CAPSULE / ORAL	RLD, RS	2019-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206089-001	JATENZO	158MG	CAPSULE / ORAL	RLD	2019-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206089-002	JATENZO	198MG	CAPSULE / ORAL	RLD	2019-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206089-003	JATENZO	237MG	CAPSULE / ORAL	RLD, RS	2019-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206089-001	JATENZO	158MG	CAPSULE / ORAL	RLD	2019-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206089-002	JATENZO	198MG	CAPSULE / ORAL	RLD	2019-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206089-003	JATENZO	237MG	CAPSULE / ORAL	RLD, RS	2019-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206089-001	JATENZO	158MG	CAPSULE / ORAL	RLD	2019-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206089-002	JATENZO	198MG	CAPSULE / ORAL	RLD	2019-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206089-003	JATENZO	237MG	CAPSULE / ORAL	RLD, RS	2019-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206089-001	JATENZO	158MG	CAPSULE / ORAL	RLD	2019-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206089-002	JATENZO	198MG	CAPSULE / ORAL	RLD	2019-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206089-003	JATENZO	237MG	CAPSULE / ORAL	RLD, RS	2019-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206089-001	JATENZO	158MG	CAPSULE / ORAL	RLD	2019-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206089-002	JATENZO	198MG	CAPSULE / ORAL	RLD	2019-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206089-003	JATENZO	237MG	CAPSULE / ORAL	RLD, RS	2019-03-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206089-001	JATENZO	158MG	CAPSULE / ORAL	RLD	2019-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206089-002	JATENZO	198MG	CAPSULE / ORAL	RLD	2019-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206089-003	JATENZO	237MG	CAPSULE / ORAL	RLD, RS	2019-03-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206089-001	JATENZO	158MG	CAPSULE / ORAL	RLD	2019-03-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206089-002	JATENZO	198MG	CAPSULE / ORAL	RLD	2019-03-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206089-003	JATENZO	237MG	CAPSULE / ORAL	RLD, RS	2019-03-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206089-001	JATENZO	158MG	CAPSULE / ORAL	RLD	2019-03-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206089-002	JATENZO	198MG	CAPSULE / ORAL	RLD	2019-03-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206089-003	JATENZO	237MG	CAPSULE / ORAL	RLD, RS	2019-03-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206089-001	JATENZO	158MG	CAPSULE / ORAL	RLD	2019-03-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206089-002	JATENZO	198MG	CAPSULE / ORAL	RLD	2019-03-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206089-003	JATENZO	237MG	CAPSULE / ORAL	RLD, RS	2019-03-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206089-001	JATENZO	158MG	CAPSULE / ORAL	RLD	2019-03-27	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 26 · 1,020 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	N206089-001	11179402	2026-04-14		Drug substance, Drug product	2021-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-001	11331325	2027-01-06	U-2506		2022-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-001	8241664	2029-03-29	U-2506	Drug product	2019-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-001	10543219	2030-04-12	U-2506		2020-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-001	10617696	2030-04-12		Drug substance, Drug product	2020-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-001	11179403	2030-04-12	U-2506		2021-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-001	11426416	2030-04-12	U-3420		2022-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-001	8778916	2030-04-12		Drug product	2019-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-001	8492369	2030-12-20	U-2506	Drug product	2019-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-001	11564933	2039-04-12	U-1103		2023-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-002	11179402	2026-04-14		Drug substance, Drug product	2021-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-002	11331325	2027-01-06	U-2506		2022-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-002	8241664	2029-03-29	U-2506	Drug product	2019-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-002	10543219	2030-04-12	U-2506		2020-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-002	10617696	2030-04-12		Drug substance, Drug product	2020-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-002	11179403	2030-04-12	U-2506		2021-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-002	11426416	2030-04-12	U-3420		2022-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-002	8778916	2030-04-12		Drug product	2019-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-002	8492369	2030-12-20	U-2506	Drug product	2019-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-002	11564933	2039-04-12	U-1103		2023-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-003	11179402	2026-04-14		Drug substance, Drug product	2021-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-003	11331325	2027-01-06	U-2506		2022-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-003	8241664	2029-03-29	U-2506	Drug product	2019-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-003	10543219	2030-04-12	U-2506		2020-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-003	10617696	2030-04-12		Drug substance, Drug product	2020-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-003	11179403	2030-04-12	U-2506		2021-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-003	11426416	2030-04-12	U-3420		2022-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-003	8778916	2030-04-12		Drug product	2019-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-003	8492369	2030-12-20	U-2506	Drug product	2019-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206089-003	11564933	2039-04-12	U-1103		2023-02-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206089-001	11179402	2026-04-14		Drug substance, Drug product	2021-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206089-001	11331325	2027-01-06	U-2506		2022-06-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206089-001	8241664	2029-03-29	U-2506	Drug product	2019-04-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206089-001	10543219	2030-04-12	U-2506		2020-02-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206089-001	10617696	2030-04-12		Drug substance, Drug product	2020-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206089-001	11179403	2030-04-12	U-2506		2021-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206089-001	11426416	2030-04-12	U-3420		2022-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206089-001	8778916	2030-04-12		Drug product	2019-04-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206089-001	8492369	2030-12-20	U-2506	Drug product	2019-04-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206089-001	11564933	2039-04-12	U-1103		2023-02-10	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 51 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206089-001	NP	2022-03-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206089-002	NP	2022-03-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206089-003	NP	2022-03-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206089-001	NP	2022-03-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206089-002	NP	2022-03-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206089-003	NP	2022-03-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206089-001	NP	2022-03-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206089-002	NP	2022-03-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206089-003	NP	2022-03-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206089-001	NP	2022-03-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206089-002	NP	2022-03-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206089-003	NP	2022-03-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206089-001	NP	2022-03-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N206089-002	NP	2022-03-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N206089-003	NP	2022-03-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206089-001	NP	2022-03-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206089-002	NP	2022-03-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206089-003	NP	2022-03-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206089-001	NP	2022-03-27	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206089-002	NP	2022-03-27	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206089-003	NP	2022-03-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N206089-001	NP	2022-03-27	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N206089-002	NP	2022-03-27	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N206089-003	NP	2022-03-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N206089-001	NP	2022-03-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N206089-002	NP	2022-03-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N206089-003	NP	2022-03-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N206089-001	NP	2022-03-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N206089-002	NP	2022-03-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N206089-003	NP	2022-03-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N206089-001	NP	2022-03-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N206089-002	NP	2022-03-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N206089-003	NP	2022-03-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N206089-001	NP	2022-03-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N206089-002	NP	2022-03-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N206089-003	NP	2022-03-27	`b00525d2431f…`
2023-01-26 05:58 UTC	2023-01	N206089-001	NP	2022-03-27	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N206089-002	NP	2022-03-27	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N206089-003	NP	2022-03-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N206089-001	NP	2022-03-27	`3a93d1ddd44b…`

Additional Listing Data#

Finished product: Yes
Brand name base: Jatenzo
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TESTOSTERONE UNDECANOATE	198 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
H16A5VCT9C	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2121766	Internal RxNorm lookup
2121768	Internal RxNorm lookup
2121770	Internal RxNorm lookup
2121776	Internal RxNorm lookup
2201640	Internal RxNorm lookup
2201642	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
ed7b5d41-7475-4c10-99b9-b62b3434ae60	Available on FDA.report

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
69087-198-12	Jatenzo	12 in 1 BOX	CAPSULE, LIQUID FILLED	12		12
69087-198-12	Jatenzo	120 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	120		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69087-198-12	EA - Each	69087-198	77ad506d-bb18-4207-bc32-85e159391822	1	2020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69087-198	JATENZO (TESTOSTERONE UNDECANOATE) CAPSULE, LIQUID FILLED [TOLMAR INC.]	8	Current NDC, Legacy NDC, 2 package rows	20250522_ed7b5d41-7475-4c10-99b9-b62b3434ae60.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
Jatenzo	TESTOSTERONE UNDECANOATE	TOLMAR Inc.	ed7b5d41-7475-4c10-99b9-b62b3434ae60	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 206089 application number: NDA206089 ndc (product): 69087-198

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
2201640	JATENZO 158 MG Oral Capsule	PSN	ed7b5d41-7475-4c10-99b9-b62b3434ae60	12
2201642	JATENZO 198 MG Oral Capsule	PSN	ed7b5d41-7475-4c10-99b9-b62b3434ae60	12
2121776	JATENZO 237 MG Oral Capsule	PSN	ed7b5d41-7475-4c10-99b9-b62b3434ae60	12
2121766	testosterone undecanoate 158 MG Oral Capsule	PSN	ed7b5d41-7475-4c10-99b9-b62b3434ae60	12
2121768	testosterone undecanoate 198 MG Oral Capsule	PSN	ed7b5d41-7475-4c10-99b9-b62b3434ae60	12
2121770	testosterone undecanoate 237 MG Oral Capsule	PSN	ed7b5d41-7475-4c10-99b9-b62b3434ae60	12
2201640	testosterone undecanoate 158 MG Oral Capsule [Jatenzo]	SBD	ed7b5d41-7475-4c10-99b9-b62b3434ae60	12
2201642	testosterone undecanoate 198 MG Oral Capsule [Jatenzo]	SBD	ed7b5d41-7475-4c10-99b9-b62b3434ae60	12
2121776	testosterone undecanoate 237 MG Oral Capsule [Jatenzo]	SBD	ed7b5d41-7475-4c10-99b9-b62b3434ae60	12
2121766	testosterone undecanoate 158 MG Oral Capsule	SCD	ed7b5d41-7475-4c10-99b9-b62b3434ae60	12
2121768	testosterone undecanoate 198 MG Oral Capsule	SCD	ed7b5d41-7475-4c10-99b9-b62b3434ae60	12
2121770	testosterone undecanoate 237 MG Oral Capsule	SCD	ed7b5d41-7475-4c10-99b9-b62b3434ae60	12
2201640	Jatenzo 158 MG Oral Capsule	SY	ed7b5d41-7475-4c10-99b9-b62b3434ae60	12
2201642	Jatenzo 198 MG Oral Capsule	SY	ed7b5d41-7475-4c10-99b9-b62b3434ae60	12
2121776	Jatenzo 237 MG Oral Capsule	SY	ed7b5d41-7475-4c10-99b9-b62b3434ae60	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69087-198-12	69087019812	12 BOTTLE, PLASTIC in 1 BOX (69087-198-12) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC	2019-08-01	0000-00-00	No	No	Current