FDA.reportPublic FDA data

TWYNEO

Product NDC
0299-5945
11-digit product format
002995945
Labeler code
0299
Product ID
0299-5945_c8da4970-d262-4f55-a092-0a469789eb1f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tretinoin and benzoyl peroxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Galderma Laboratories, L.P.
Application
NDA214902
Marketing category
NDA
Marketing start
2022-03-15
Marketing end
2026-10-31
Substance
BENZOYL PEROXIDE; TRETINOIN
Active strength
30; 1 mg/g; mg/g
Pharmacologic classes
Retinoid [EPC], Retinoids [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TWYNEO

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOYL PEROXIDE30 mg/g
TRETINOIN1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW9WZN9A0GM, 5688UTC01R
Rxcui2565807, 2565812

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b80ad7bc-1b6f-7ef4-1ed0-86cd9f459d60Product name620251124
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
1426d8f8-b7d5-4053-8554-613df00c0d86Product name220250616
0e7b8bf1-c46c-4de6-b26a-0c50e34364ecProduct name220250521
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
e3af9708-3004-7392-4046-5311eaa8bab5Product name320221128
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
503b047e-e62d-4745-9011-522b13bc701bProduct name120181206
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
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
0299-5945-00TWYNEO6 g in 1 TUBECREAM66
0299-5945-05TWYNEO30 g in 1 BOTTLE, PUMPCREAM306
0299-5945-30TWYNEO1 in 1 BOXCREAM16
0299-5945-30TWYNEO30 g in 1 BOTTLE, PUMPCREAM306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0299-5945-30GM - Gram0299-59456f4abdd4-bb63-4e12-849f-1209b554e10612022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0299-5945TWYNEO (TRETINOIN AND BENZOYL PEROXIDE) CREAM [GALDERMA LABORATORIES, L.P.]5Current NDC, Legacy NDC, 4 package rows20241114_27208dff-e376-4c18-b56e-0a260f685a39.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2565807benzoyl peroxide 3 % / tretinoin 0.1 % Topical CreamPSN27208dff-e376-4c18-b56e-0a260f685a396
2565812Twyneo 3 % / 0.1 % Topical CreamPSN27208dff-e376-4c18-b56e-0a260f685a396
2565812benzoyl peroxide 30 MG/ML / tretinoin 1 MG/ML Topical Cream [Twyneo]SBD27208dff-e376-4c18-b56e-0a260f685a396
2565807benzoyl peroxide 30 MG/ML / tretinoin 1 MG/ML Topical CreamSCD27208dff-e376-4c18-b56e-0a260f685a396
2565807benzoyl peroxide 3 % / tretinoin 0.1 % Topical CreamSY27208dff-e376-4c18-b56e-0a260f685a396
2565812Twyneo (benzoyl peroxide 3 % / tretinoin 0.1 % ) Topical CreamSY27208dff-e376-4c18-b56e-0a260f685a396

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0299-5945-00002995945006 g in 1 TUBE (0299-5945-00) 6 g2022-03-152026-10-31YesNoCurrent
0299-5945-050029959450530 g in 1 BOTTLE, PUMP (0299-5945-05) 30 g2023-07-112026-10-31YesNoHistorical
0299-5945-30002995945301 BOTTLE, PUMP in 1 BOX (0299-5945-30) / 30 g in 1 BOTTLE, PUMP2022-03-152026-10-31NoNoCurrent