FDA.reportPublic FDA data

Renova

Product NDC
0187-5150
11-digit product format
001875150
Labeler code
0187
Product ID
0187-5150_440beed5-a673-423d-84e8-4f3432c37ee8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tretinoin
Dosage form
CREAM
Route
TOPICAL
Labeler
Bausch Health US LLC
Application
NDA021108
Marketing category
NDA
Marketing start
2000-08-31
Substance
TRETINOIN
Active strength
.2 mg/g
Pharmacologic classes
Retinoid [EPC], Retinoids [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRETINOIN.2 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5688UTC01R
Rxcui252265, 846955

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0187-5150-02Renova2 g in 1 TUBECREAM214
0187-5150-02Renova1 in 1 CARTONCREAM114
0187-5150-20Renova1 in 1 CARTONCREAM114
0187-5150-20Renova20 g in 1 TUBECREAM2014
0187-5150-40Renova1 in 1 CARTONCREAM114
0187-5150-40Renova40 g in 1 TUBECREAM4014
0187-5150-44Renova44 g in 1 BOTTLE, PUMPCREAM4414
0187-5150-44Renova1 in 1 CARTONCREAM114
0187-5150-60Renova60 g in 1 TUBECREAM6014
0187-5150-60Renova1 in 1 CARTONCREAM114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0187-5150-20GM - Gram0187-51505afa4192-7fe5-4f80-afa9-13e8a501e0a412019-09-05
0187-5150-44GM - Gram0187-51501f9c3c24-01a0-4926-a9fb-08c6bc7abadc12013-11-04
0187-5150-60GM - Gram0187-5150ef354477-f02b-4adb-84fa-0a7757d9964212014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TretinoinACTIVE INGREDIENT5688UTC01RRENOVA (TRETINOIN) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6
TretinoinACTIVE MOIETY5688UTC01RRENOVA (TRETINOIN) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6
Benzyl AlcoholINACTIVE INGREDIENTLKG8494WBHRENOVA (TRETINOIN) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6
Butylated HydroxytolueneINACTIVE INGREDIENT1P9D0Z171KRENOVA (TRETINOIN) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCNRENOVA (TRETINOIN) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KRENOVA (TRETINOIN) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6
Medium-Chain TriglyceridesINACTIVE INGREDIENTC9H2L21V7URENOVA (TRETINOIN) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TRENOVA (TRETINOIN) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHRENOVA (TRETINOIN) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6
Steareth-2INACTIVE INGREDIENTV56DFE46J5RENOVA (TRETINOIN) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6
Steareth-20INACTIVE INGREDIENTL0Q8IK9E08RENOVA (TRETINOIN) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6
Stearic AcidINACTIVE INGREDIENT4ELV7Z65APRENOVA (TRETINOIN) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6
Stearyl AlcoholINACTIVE INGREDIENT2KR89I4H1YRENOVA (TRETINOIN) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6
WaterINACTIVE INGREDIENT059QF0KO0RRENOVA (TRETINOIN) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6
Xanthan GumINACTIVE INGREDIENTTTV12P4NEERENOVA (TRETINOIN) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0187-5150RENOVA (TRETINOIN) CREAM [BAUSCH HEALTH US LLC]12Current NDC, Legacy NDC, 10 package rows20200924_9f0a0e8d-1051-48a4-80c5-1bd260dd9c36.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
846955RENOVA 0.02 % Topical CreamPSN9f0a0e8d-1051-48a4-80c5-1bd260dd9c3614
252265tretinoin 0.02 % Topical CreamPSN9f0a0e8d-1051-48a4-80c5-1bd260dd9c3614
846955tretinoin 0.2 MG/ML Topical Cream [Renova]SBD9f0a0e8d-1051-48a4-80c5-1bd260dd9c3614
252265tretinoin 0.2 MG/ML Topical CreamSCD9f0a0e8d-1051-48a4-80c5-1bd260dd9c3614
846955Renova 0.02 % Topical CreamSY9f0a0e8d-1051-48a4-80c5-1bd260dd9c3614
846955Renova 0.2 MG/ML Topical CreamSY9f0a0e8d-1051-48a4-80c5-1bd260dd9c3614
252265tretinoin 0.02 % Topical CreamSY9f0a0e8d-1051-48a4-80c5-1bd260dd9c3614

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0187-5150-02001875150021 TUBE in 1 CARTON (0187-5150-02) / 2 g in 1 TUBE1 tube2000-08-310000-00-00NoNoCurrent
0187-5150-20001875150201 TUBE in 1 CARTON (0187-5150-20) / 20 g in 1 TUBE1 tube2000-08-310000-00-00NoNoCurrent
0187-5150-40001875150401 TUBE in 1 CARTON (0187-5150-40) / 40 g in 1 TUBE1 tube2000-08-310000-00-00NoNoCurrent
0187-5150-44001875150441 BOTTLE, PUMP in 1 CARTON (0187-5150-44) / 44 g in 1 BOTTLE, PUMP2000-08-310000-00-00NoNoCurrent
0187-5150-60001875150601 TUBE in 1 CARTON (0187-5150-60) / 60 g in 1 TUBE1 tube2000-08-310000-00-00NoNoCurrent