FDA.reportPublic FDA data

Tretinoin

Product NDC
16714-250
11-digit product format
167140250
Labeler code
16714
Product ID
16714-250_39809802-b48a-ea14-e063-6394a90a1380
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tretinoin
Dosage form
CREAM
Route
TOPICAL
Labeler
NORTHSTAR RX LLC
Application
ANDA211645
Marketing category
ANDA
Marketing start
2019-01-22
Substance
TRETINOIN
Active strength
1 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
TRETINOIN1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5688UTC01R
Rxcui198300

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
16714-250-01Tretinoin20 g in 1 TUBECREAM202
16714-250-01Tretinoin1 in 1 CARTONCREAM12
16714-250-02Tretinoin1 in 1 CARTONCREAM12
16714-250-02Tretinoin45 g in 1 TUBECREAM452

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-250-01GM - Gram16714-250251a2901-7404-4e2a-9681-30276e39df1612022-05-04
16714-250-02GM - Gram16714-25040ff0d68-ccb6-4b17-9547-a8a2b9721db612022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-250TRETINOIN CREAM [NORTHSTAR RX LLC]1Current NDC, Legacy NDC, 4 package rows20220305_de3e7308-1212-4727-b541-568a84dac48a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198300tretinoin 0.1 % Topical CreamPSNde3e7308-1212-4727-b541-568a84dac48a2
198300tretinoin 1 MG/ML Topical CreamSCDde3e7308-1212-4727-b541-568a84dac48a2
198300tretinoin 0.1 % Topical CreamSYde3e7308-1212-4727-b541-568a84dac48a2
198300tretinoin 0.1 % Topical CreamPSN3ded762b-5fe6-c5ef-e063-6294a90ad6021
198300tretinoin 1 MG/ML Topical CreamSCD3ded762b-5fe6-c5ef-e063-6294a90ad6021
198300tretinoin 0.1 % Topical CreamSY3ded762b-5fe6-c5ef-e063-6294a90ad6021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-250-01167140250011 TUBE in 1 CARTON (16714-250-01) / 20 g in 1 TUBE1 tube2022-02-250000-00-00NoNoCurrent
16714-250-02167140250021 TUBE in 1 CARTON (16714-250-02) / 45 g in 1 TUBE1 tube2022-02-250000-00-00NoNoCurrent