Altreno

Product NDC
0187-0005
11-digit product format
001870005
Labeler code
0187
Product ID
0187-0005_f942f9b5-aa0b-4729-98c5-76f50afcac88
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
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N209353-001ALTRENOTRETINOIN0.05%LOTION / TOPICALRLD, RS2018-08-23

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N209353-001106536562038-08-22U-2368Drug product2020-05-28
N209353-001113247102038-08-22U-23682022-06-08

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N209353-001ALTRENO0.05%LOTION / TOPICALRLD, RS2018-08-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209353-001ALTRENO0.05%LOTION / TOPICALRLD, RS2018-08-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N209353-001ALTRENO0.05%LOTION / TOPICALRLD, RS2018-08-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209353-001ALTRENO0.05%LOTION / TOPICALRLD, RS2018-08-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209353-001ALTRENO0.05%LOTION / TOPICALRLD, RS2018-08-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209353-001ALTRENO0.05%LOTION / TOPICALRLD, RS2018-08-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209353-001ALTRENO0.05%LOTION / TOPICALRLD, RS2018-08-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209353-001ALTRENO0.05%LOTION / TOPICALRLD, RS2018-08-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209353-001ALTRENO0.05%LOTION / TOPICALRLD, RS2018-08-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N209353-001ALTRENO0.05%LOTION / TOPICALRLD, RS2018-08-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209353-001ALTRENO0.05%LOTION / TOPICALRLD, RS2018-08-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209353-001ALTRENO0.05%LOTION / TOPICALRLD, RS2018-08-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N209353-001ALTRENO0.05%LOTION / TOPICALRLD, RS2018-08-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05N209353-001ALTRENO0.05%LOTION / TOPICALRLD, RS2018-08-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209353-001ALTRENO0.05%LOTION / TOPICALRLD, RS2018-08-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N209353-001ALTRENO0.05%LOTION / TOPICALRLD, RS2018-08-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N209353-001ALTRENO0.05%LOTION / TOPICALRLD, RS2018-08-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N209353-001ALTRENO0.05%LOTION / TOPICALRLD, RS2018-08-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N209353-001ALTRENO0.05%LOTION / TOPICALRLD, RS2018-08-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N209353-001ALTRENO0.05%LOTION / TOPICALRLD, RS2018-08-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N209353-001ALTRENO0.05%LOTION / TOPICALRLD, RS2018-08-2387673890dc5c…
2021-03-12 10:30 UTC2021-03N209353-001ALTRENO0.05%LOTION / TOPICALRLD, RS2018-08-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N209353-001ALTRENO0.05%LOTION / TOPICALRLD, RS2018-08-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11N209353-001ALTRENO0.05%LOTION / TOPICALRLD, RS2018-08-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12N209353-001ALTRENO0.05%LOTION / TOPICALRLD, RS2018-08-233f01610625f2…
2019-09-15 20:21 UTC2019-09N209353-001ALTRENO0.05%LOTION / TOPICALRLD, RS2018-08-23b00525d2431f…
2019-07-19 19:46 UTC2019-07N209353-001ALTRENO0.05%LOTION / TOPICALRLD, RS2018-08-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N209353-001ALTRENO0.05%LOTION / TOPICALRLD, RS2018-08-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N209353-001ALTRENO0.05%LOTION / TOPICALRLD, RS2018-08-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12N209353-001ALTRENO0.05%LOTION / TOPICALRLD, RS2018-08-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N209353-001ALTRENO0.05%LOTION / TOPICALRLD, RS2018-08-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N209353-001ALTRENO0.05%LOTION / TOPICALRLD, RS2018-08-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N209353-001ALTRENO0.05%LOTION / TOPICALRLD, RS2018-08-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N209353-001ALTRENO0.05%LOTION / TOPICALRLD, RS2018-08-233f0d92c62455…
2023-05-13 08:27 UTC2023-05N209353-001ALTRENO0.05%LOTION / TOPICALRLD, RS2018-08-23053a50430f4f…
2023-01-26 05:58 UTC2023-01N209353-001ALTRENO0.05%LOTION / TOPICALRLD, RS2018-08-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N209353-001ALTRENO0.05%LOTION / TOPICALRLD, RS2018-08-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N209353-001ALTRENO0.05%LOTION / TOPICALRLD, RS2018-08-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N209353-001ALTRENO0.05%LOTION / TOPICALRLD, RS2018-08-23e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N209353-001ALTRENO0.05%LOTION / TOPICALRLD, RS2018-08-23cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N209353-001106536562038-08-22U-2368Drug product2020-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209353-001113247102038-08-22U-23682022-06-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209353-001106536562038-08-22U-2368Drug product2020-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209353-001113247102038-08-22U-23682022-06-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N209353-001106536562038-08-22U-2368Drug product2020-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209353-001113247102038-08-22U-23682022-06-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209353-001106536562038-08-22U-2368Drug product2020-05-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209353-001113247102038-08-22U-23682022-06-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209353-001106536562038-08-22U-2368Drug product2020-05-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209353-001113247102038-08-22U-23682022-06-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209353-001106536562038-08-22U-2368Drug product2020-05-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209353-001113247102038-08-22U-23682022-06-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209353-001106536562038-08-22U-2368Drug product2020-05-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209353-001113247102038-08-22U-23682022-06-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209353-001106536562038-08-22U-2368Drug product2020-05-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209353-001113247102038-08-22U-23682022-06-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209353-001106536562038-08-22U-2368Drug product2020-05-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209353-001113247102038-08-22U-23682022-06-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N209353-001106536562038-08-22U-2368Drug product2020-05-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N209353-001113247102038-08-22U-23682022-06-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209353-001106536562038-08-22U-2368Drug product2020-05-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209353-001113247102038-08-22U-23682022-06-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209353-001106536562038-08-22U-2368Drug product2020-05-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209353-001113247102038-08-22U-23682022-06-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N209353-001106536562038-08-22U-2368Drug product2020-05-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N209353-001113247102038-08-22U-23682022-06-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05N209353-001106536562038-08-22U-2368Drug product2020-05-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05N209353-001113247102038-08-22U-23682022-06-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209353-001106536562038-08-22U-2368Drug product2020-05-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209353-001113247102038-08-22U-23682022-06-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N209353-001106536562038-08-22U-2368Drug product2020-05-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N209353-001106536562038-08-22U-2368Drug product2020-05-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N209353-00165178472020-08-03U-2368Drug product2018-08-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N209353-001106536562038-08-22U-2368Drug product2020-05-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N209353-001106536562038-08-22U-2368Drug product2020-05-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N209353-001106536562038-08-22U-2368Drug product2020-05-2887673890dc5c…
2021-03-12 10:30 UTC2021-03N209353-001106536562038-08-22U-2368Drug product2020-05-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N209353-00165178472020-08-03U-2368Drug product2018-08-308869cabd3fbd…
2020-12-22 03:56 UTC2020-12N209353-001106536562038-08-22U-2368Drug product2020-05-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11N209353-00165178472020-08-03U-2368Drug product2018-08-30c0c555d07b60…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N209353-001NDF2021-08-2374a2ff9319b5…
2021-12-28 21:50 UTC2021-12N209353-001NDF2021-08-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N209353-001NDF2021-08-2387673890dc5c…
2021-03-12 10:30 UTC2021-03N209353-001NDF2021-08-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N209353-001NDF2021-08-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11N209353-001NDF2021-08-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12N209353-001NDF2021-08-233f01610625f2…
2019-09-15 20:21 UTC2019-09N209353-001NDF2021-08-23b00525d2431f…
2019-07-19 19:46 UTC2019-07N209353-001NDF2021-08-23ea99ee380514…

Additional Listing Data#

Finished product
Yes
Brand name base
Altreno
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRETINOIN.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5688UTC01RInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
250939Internal RxNorm lookup
2055008Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1412aba5-71aa-4cce-8db4-c189bed1852cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b80ad7bc-1b6f-7ef4-1ed0-86cd9f459d60Product name620251124
1426d8f8-b7d5-4053-8554-613df00c0d86Product name220250616
0e7b8bf1-c46c-4de6-b26a-0c50e34364ecProduct name220250521
e3af9708-3004-7392-4046-5311eaa8bab5Product name320221128
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
503b047e-e62d-4745-9011-522b13bc701bProduct name120181206
7d41caa2-0b5d-9b03-ab8d-84271de26ef4Product name220170314
50ca9ff5-82dd-9971-4f2c-5845a76a8572Product name220150818
0a8118e4-08c6-b395-9ddc-d3e425e0493aProduct name120140508
233bcb0a-cf40-b0a1-b346-c83ac2f43579Product name120140508
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0187-0005-03Altreno3 g in 1 TUBELOTION316
0187-0005-03Altreno6 in 1 CARTONLOTION616
0187-0005-04Altreno3 g in 1 TUBELOTION316
0187-0005-10Altreno10 in 1 CARTONLOTION1016
0187-0005-20Altreno1 in 1 CARTONLOTION116
0187-0005-20Altreno20 g in 1 TUBELOTION2016
0187-0005-45Altreno1 in 1 CARTONLOTION116
0187-0005-45Altreno45 g in 1 TUBELOTION4516
0187-0005-50Altreno1 in 1 CARTONLOTION116
0187-0005-50Altreno50 g in 1 BOTTLE, PUMPLOTION5016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0187-0005-20GM - Gram0187-000580788c7b-e853-4dc0-9116-c8cfc8d81f1512019-11-12
0187-0005-45GM - Gram0187-000591768f8e-63a2-4579-a82a-096811d6bdc212018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0187-0005ALTRENO (TRETINOIN) LOTION [BAUSCH HEALTH US, LLC]16Current NDC, Legacy NDC, 10 package rows20200620_1412aba5-71aa-4cce-8db4-c189bed1852c.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AltrenoTRETINOINBausch Health US, LLC1412aba5-71aa-4cce-8db4-c189bed1852c2020-03-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 209353
application number: NDA209353
ndc (product): 0187-0005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2055008Altreno 0.05 % Topical LotionPSN1412aba5-71aa-4cce-8db4-c189bed1852c16
250939tretinoin 0.05 % Topical LotionPSN1412aba5-71aa-4cce-8db4-c189bed1852c16
2055008tretinoin 0.5 MG/ML Topical Lotion [Altreno]SBD1412aba5-71aa-4cce-8db4-c189bed1852c16
250939tretinoin 0.5 MG/ML Topical LotionSCD1412aba5-71aa-4cce-8db4-c189bed1852c16
2055008Altreno 0.05 % Topical LotionSY1412aba5-71aa-4cce-8db4-c189bed1852c16
2055008Altreno 0.5 MG/ML Topical LotionSY1412aba5-71aa-4cce-8db4-c189bed1852c16
250939tretinoin 0.05 % Topical LotionSY1412aba5-71aa-4cce-8db4-c189bed1852c16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0187-0005-03001870005036 TUBE in 1 CARTON (0187-0005-03) / 3 g in 1 TUBE6 tube2018-08-240000-00-00YesNoCurrent
0187-0005-04001870005043 g in 1 TUBE3 gHistorical
0187-0005-100018700051010 TUBE in 1 CARTON (0187-0005-10) / 3 g in 1 TUBE (0187-0005-04) 10 tube2019-05-220000-00-00YesNoCurrent
0187-0005-20001870005201 TUBE in 1 CARTON (0187-0005-20) / 20 g in 1 TUBE1 tube2019-11-080000-00-00NoNoCurrent
0187-0005-45001870005451 TUBE in 1 CARTON (0187-0005-45) / 45 g in 1 TUBE1 tube2018-08-240000-00-00NoNoCurrent
0187-0005-50001870005501 BOTTLE, PUMP in 1 CARTON (0187-0005-50) / 50 g in 1 BOTTLE, PUMP2019-04-130000-00-00NoNoCurrent