Jatenzo

Product NDC: 69087-158
Requested package NDC: 69087-158-12
11-digit product format: 690870158
Labeler code: 69087
Product ID: 69087-158_0a548ae2-aa56-49bd-a339-a7b2b66fdb5c
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: 158 mg/1
Pharmacologic classes: Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
DEA schedule: CIII
NDC exclude flag: No
Listing certified through: 2027-12-31
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	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 · 132 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	N206089-001	JATENZO	158MG	CAPSULE / ORAL	RLD	2019-03-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206089-002	JATENZO	198MG	CAPSULE / ORAL	RLD	2019-03-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206089-003	JATENZO	237MG	CAPSULE / ORAL	RLD, RS	2019-03-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N206089-001	JATENZO	158MG	CAPSULE / ORAL	RLD	2019-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206089-002	JATENZO	198MG	CAPSULE / ORAL	RLD	2019-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206089-003	JATENZO	237MG	CAPSULE / ORAL	RLD, RS	2019-03-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N206089-001	JATENZO	158MG	CAPSULE / ORAL	RLD	2019-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206089-002	JATENZO	198MG	CAPSULE / ORAL	RLD	2019-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206089-003	JATENZO	237MG	CAPSULE / ORAL	RLD, RS	2019-03-27	`caaa826d4ba7…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 28 · 1,119 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	N206089-001	11179402	2026-04-14		Drug substance, Drug product	2021-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206089-001	11331325	2027-01-06	U-2506		2022-06-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206089-001	8241664	2029-03-29	U-2506	Drug product	2019-04-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206089-001	10543219	2030-04-12	U-2506		2020-02-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206089-001	10617696	2030-04-12		Drug substance, Drug product	2020-05-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206089-001	11179403	2030-04-12	U-2506		2021-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206089-001	11426416	2030-04-12	U-3420		2022-09-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206089-001	8778916	2030-04-12		Drug product	2019-04-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206089-001	8492369	2030-12-20	U-2506	Drug product	2019-04-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206089-001	11564933	2039-04-12	U-1103		2023-02-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206089-001	12605391	2039-04-12	U-1103		2026-04-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206089-002	11179402	2026-04-14		Drug substance, Drug product	2021-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206089-002	11331325	2027-01-06	U-2506		2022-06-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206089-002	8241664	2029-03-29	U-2506	Drug product	2019-04-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206089-002	10543219	2030-04-12	U-2506		2020-02-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206089-002	10617696	2030-04-12		Drug substance, Drug product	2020-05-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206089-002	11179403	2030-04-12	U-2506		2021-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206089-002	11426416	2030-04-12	U-3420		2022-09-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206089-002	8778916	2030-04-12		Drug product	2019-04-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206089-002	8492369	2030-12-20	U-2506	Drug product	2019-04-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206089-002	11564933	2039-04-12	U-1103		2023-02-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206089-002	12605391	2039-04-12	U-1103		2026-04-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206089-003	11179402	2026-04-14		Drug substance, Drug product	2021-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206089-003	11331325	2027-01-06	U-2506		2022-06-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206089-003	8241664	2029-03-29	U-2506	Drug product	2019-04-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206089-003	10543219	2030-04-12	U-2506		2020-02-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206089-003	10617696	2030-04-12		Drug substance, Drug product	2020-05-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206089-003	11179403	2030-04-12	U-2506		2021-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206089-003	11426416	2030-04-12	U-3420		2022-09-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206089-003	8778916	2030-04-12		Drug product	2019-04-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206089-003	8492369	2030-12-20	U-2506	Drug product	2019-04-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206089-003	11564933	2039-04-12	U-1103		2023-02-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206089-003	12605391	2039-04-12	U-1103		2026-04-24	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N206089-001	11179402	2026-04-14		Drug substance, Drug product	2021-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206089-001	11331325	2027-01-06	U-2506		2022-06-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206089-001	8241664	2029-03-29	U-2506	Drug product	2019-04-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206089-001	10543219	2030-04-12	U-2506		2020-02-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206089-001	10617696	2030-04-12		Drug substance, Drug product	2020-05-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206089-001	11179403	2030-04-12	U-2506		2021-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206089-001	11426416	2030-04-12	U-3420		2022-09-12	`84e616aacf4f…`

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…`

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: Jatenzo
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TESTOSTERONE UNDECANOATE	158 mg/1

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
69087-158-12	Jatenzo	120 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	120		12
69087-158-12	Jatenzo	12 in 1 BOX	CAPSULE, LIQUID FILLED	12		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69087-158-12	EA - Each	69087-158	94bde7a5-5f94-4c79-953f-24df127a348f	1	2020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69087-158	JATENZO (TESTOSTERONE UNDECANOATE) CAPSULE, LIQUID FILLED [TOLMAR INC.]	8	Current NDC, Legacy NDC, 2 package rows	20250522_ed7b5d41-7475-4c10-99b9-b62b3434ae60.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
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
69087-158-12	69087015812	120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69087-158-12)	2019-08-01	0000-00-00	No	No	Current