FDA.reportPublic FDA data

Tretinoin

Product NDC
16714-270
11-digit product format
167140270
Labeler code
16714
Product ID
16714-270_3629fc6a-a4f9-926e-e063-6294a90affdb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tretinoin
Dosage form
CREAM
Route
TOPICAL
Labeler
NORTHSTAR RX LLC
Application
ANDA215713
Marketing category
ANDA
Marketing start
2023-01-05
Substance
TRETINOIN
Active strength
.25 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
Tretinoin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRETINOIN.25 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5688UTC01R
Rxcui106302

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
16714-270-01Tretinoin20 g in 1 TUBECREAM202
16714-270-01Tretinoin1 in 1 CARTONCREAM12
16714-270-02Tretinoin1 in 1 CARTONCREAM12
16714-270-02Tretinoin45 g in 1 TUBECREAM452

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-270-01GM - Gram16714-2700d4ad38f-819c-4c94-b77e-2902879d511112024-08-12
16714-270-02GM - Gram16714-27009ac39ba-7f84-48b8-80b7-cd1507013dc112024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-270TRETINOIN CREAM [NORTHSTAR RX LLC]2Current NDC, 4 package rows20250529_c0212b19-0676-4546-bc5d-682c089e7b7d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106302tretinoin 0.025 % Topical CreamPSNc0212b19-0676-4546-bc5d-682c089e7b7d2
106302tretinoin 0.25 MG/ML Topical CreamSCDc0212b19-0676-4546-bc5d-682c089e7b7d2
106302tretinoin 0.025 % Topical CreamSYc0212b19-0676-4546-bc5d-682c089e7b7d2
106302tretinoin 0.025 % Topical CreamPSN3deccf35-67ad-9cbc-e063-6394a90a7ee91
106302tretinoin 0.25 MG/ML Topical CreamSCD3deccf35-67ad-9cbc-e063-6394a90a7ee91
106302tretinoin 0.025 % Topical CreamSY3deccf35-67ad-9cbc-e063-6394a90a7ee91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
16714-270-01167140270011 TUBE in 1 CARTON (16714-270-01) / 20 g in 1 TUBE1 tube2023-01-05NoNoCurrent
16714-270-02167140270021 TUBE in 1 CARTON (16714-270-02) / 45 g in 1 TUBE1 tube2023-01-05NoNoCurrent