Altreno

Product NDC: 0187-0005
Requested package NDC: 0187-0005-10
11-digit product format: 001870005
Labeler code: 0187
Product ID: 0187-0005_ff301ddf-dde4-485b-a9c8-9c8e9c52e8b1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tretinoin
Dosage form: LOTION
Route: TOPICAL
Labeler: Bausch Health US, LLC
Application: NDA209353
Marketing category: NDA
Marketing start: 2018-08-24
Substance: TRETINOIN
Active strength: .5 mg/g
Pharmacologic classes: Retinoid [EPC], Retinoids [CS]
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 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N209353-001	ALTRENO	TRETINOIN	0.05%	LOTION / TOPICAL		RLD, RS	2018-08-23

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209353-001	10653656	2038-08-22	U-2368	Drug product	2020-05-28
N209353-001	11324710	2038-08-22	U-2368		2022-06-08

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209353-001	ALTRENO	0.05%	LOTION / TOPICAL	RLD, RS	2018-08-23	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N209353-001	10653656	2038-08-22	U-2368	Drug product	2020-05-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209353-001	11324710	2038-08-22	U-2368		2022-06-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209353-001	10653656	2038-08-22	U-2368	Drug product	2020-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209353-001	11324710	2038-08-22	U-2368		2022-06-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209353-001	10653656	2038-08-22	U-2368	Drug product	2020-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209353-001	11324710	2038-08-22	U-2368		2022-06-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209353-001	10653656	2038-08-22	U-2368	Drug product	2020-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209353-001	11324710	2038-08-22	U-2368		2022-06-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209353-001	10653656	2038-08-22	U-2368	Drug product	2020-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209353-001	11324710	2038-08-22	U-2368		2022-06-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209353-001	10653656	2038-08-22	U-2368	Drug product	2020-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209353-001	11324710	2038-08-22	U-2368		2022-06-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209353-001	10653656	2038-08-22	U-2368	Drug product	2020-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209353-001	11324710	2038-08-22	U-2368		2022-06-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209353-001	10653656	2038-08-22	U-2368	Drug product	2020-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209353-001	11324710	2038-08-22	U-2368		2022-06-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209353-001	10653656	2038-08-22	U-2368	Drug product	2020-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209353-001	11324710	2038-08-22	U-2368		2022-06-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209353-001	10653656	2038-08-22	U-2368	Drug product	2020-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209353-001	11324710	2038-08-22	U-2368		2022-06-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209353-001	10653656	2038-08-22	U-2368	Drug product	2020-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209353-001	11324710	2038-08-22	U-2368		2022-06-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209353-001	10653656	2038-08-22	U-2368	Drug product	2020-05-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209353-001	11324710	2038-08-22	U-2368		2022-06-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209353-001	10653656	2038-08-22	U-2368	Drug product	2020-05-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209353-001	11324710	2038-08-22	U-2368		2022-06-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209353-001	10653656	2038-08-22	U-2368	Drug product	2020-05-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209353-001	11324710	2038-08-22	U-2368		2022-06-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209353-001	10653656	2038-08-22	U-2368	Drug product	2020-05-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209353-001	11324710	2038-08-22	U-2368		2022-06-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209353-001	10653656	2038-08-22	U-2368	Drug product	2020-05-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209353-001	11324710	2038-08-22	U-2368		2022-06-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209353-001	10653656	2038-08-22	U-2368	Drug product	2020-05-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209353-001	11324710	2038-08-22	U-2368		2022-06-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209353-001	10653656	2038-08-22	U-2368	Drug product	2020-05-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209353-001	10653656	2038-08-22	U-2368	Drug product	2020-05-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209353-001	6517847	2020-08-03	U-2368	Drug product	2018-08-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209353-001	10653656	2038-08-22	U-2368	Drug product	2020-05-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209353-001	10653656	2038-08-22	U-2368	Drug product	2020-05-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209353-001	10653656	2038-08-22	U-2368	Drug product	2020-05-28	`87673890dc5c…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N209353-001	NDF	2021-08-23	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N209353-001	NDF	2021-08-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209353-001	NDF	2021-08-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209353-001	NDF	2021-08-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209353-001	NDF	2021-08-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209353-001	NDF	2021-08-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209353-001	NDF	2021-08-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209353-001	NDF	2021-08-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209353-001	NDF	2021-08-23	`ea99ee380514…`

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: Altreno
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRETINOIN	.5 mg/g

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b80ad7bc-1b6f-7ef4-1ed0-86cd9f459d60	Product name	6	20251124
1426d8f8-b7d5-4053-8554-613df00c0d86	Product name	2	20250616
0e7b8bf1-c46c-4de6-b26a-0c50e34364ec	Product name	2	20250521
e3af9708-3004-7392-4046-5311eaa8bab5	Product name	3	20221128
13e7e7e3-e885-4c79-af6d-dad1aedbb06e	Product name	1	20220128
503b047e-e62d-4745-9011-522b13bc701b	Product name	1	20181206
7d41caa2-0b5d-9b03-ab8d-84271de26ef4	Product name	2	20170314
50ca9ff5-82dd-9971-4f2c-5845a76a8572	Product name	2	20150818
0a8118e4-08c6-b395-9ddc-d3e425e0493a	Product name	1	20140508
233bcb0a-cf40-b0a1-b346-c83ac2f43579	Product name	1	20140508
85490a6b-2306-6bf2-c51b-eb63537dc2da	Product name	1	20140508
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0187-0005-03	Altreno	3 g in 1 TUBE	LOTION	3	16
0187-0005-03	Altreno	6 in 1 CARTON	LOTION	6	16
0187-0005-04	Altreno	3 g in 1 TUBE	LOTION	3	16
0187-0005-10	Altreno	10 in 1 CARTON	LOTION	10	16
0187-0005-20	Altreno	1 in 1 CARTON	LOTION	1	16
0187-0005-20	Altreno	20 g in 1 TUBE	LOTION	20	16
0187-0005-45	Altreno	1 in 1 CARTON	LOTION	1	16
0187-0005-45	Altreno	45 g in 1 TUBE	LOTION	45	16
0187-0005-50	Altreno	1 in 1 CARTON	LOTION	1	16
0187-0005-50	Altreno	50 g in 1 BOTTLE, PUMP	LOTION	50	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0187-0005-20	GM - Gram	0187-0005	80788c7b-e853-4dc0-9116-c8cfc8d81f15	1	2019-11-12
0187-0005-45	GM - Gram	0187-0005	91768f8e-63a2-4579-a82a-096811d6bdc2	1	2018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0187-0005	ALTRENO (TRETINOIN) LOTION [BAUSCH HEALTH US, LLC]	16	Current NDC, Legacy NDC, 10 package rows	20200620_1412aba5-71aa-4cce-8db4-c189bed1852c.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5688UTC01R	TRETINOIN	302-79-4	TRETINOIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2055008	Altreno 0.05 % Topical Lotion	PSN	1412aba5-71aa-4cce-8db4-c189bed1852c	16
250939	tretinoin 0.05 % Topical Lotion	PSN	1412aba5-71aa-4cce-8db4-c189bed1852c	16
2055008	tretinoin 0.5 MG/ML Topical Lotion [Altreno]	SBD	1412aba5-71aa-4cce-8db4-c189bed1852c	16
250939	tretinoin 0.5 MG/ML Topical Lotion	SCD	1412aba5-71aa-4cce-8db4-c189bed1852c	16
2055008	Altreno 0.05 % Topical Lotion	SY	1412aba5-71aa-4cce-8db4-c189bed1852c	16
2055008	Altreno 0.5 MG/ML Topical Lotion	SY	1412aba5-71aa-4cce-8db4-c189bed1852c	16
250939	tretinoin 0.05 % Topical Lotion	SY	1412aba5-71aa-4cce-8db4-c189bed1852c	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0187-0005-10	00187000510	10 TUBE in 1 CARTON (0187-0005-10) / 3 g in 1 TUBE (0187-0005-04)	10 tube	2019-05-22	0000-00-00	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Altreno	Bausch Health US, LLC \| Bausch Health Companies Inc.	2026-10-14	HUMAN PRESCRIPTION DRUG LABEL	17