FDA.reportPublic FDA data

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

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 Identifiers#

Field, Values table
FieldValues
Unii5688UTC01R
Rxcui250939, 2055008

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

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