FDA.reportPublic FDA data

Tretinoin

Product NDC
21922-079
11-digit product format
219220079
Labeler code
21922
Product ID
21922-079_916137d0-edab-466c-8ec9-ffbe7b6cf162
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tretinoin
Dosage form
CREAM
Route
TOPICAL
Labeler
Encube Ethicals, Inc.
Application
ANDA217831
Marketing category
ANDA
Marketing start
2025-07-11
Substance
TRETINOIN
Active strength
.25 mg/g
Pharmacologic classes
Retinoid [EPC], Retinoids [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217831-001TRETINOINTRETINOIN0.025%CREAM / TOPICALAB2025-07-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A217831-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A217831-001TRETINOIN0.025%CREAM / TOPICALAB2025-07-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217831-001TRETINOIN0.025%CREAM / TOPICALAB2025-07-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A217831-001TRETINOIN0.025%CREAM / TOPICALAB2025-07-106a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217831-001TRETINOIN0.025%CREAM / TOPICALAB2025-07-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A217831-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217831-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217831-001AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217831-001AB1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRETINOIN.25 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5688UTC01RInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
106302Internal RxNorm lookup
106303Internal RxNorm lookup
198300Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5e3fb8ea-234c-4be2-95a7-d139e069cf98Available on FDA.report

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
21922-079-06Tretinoin1 in 1 CARTONCREAM14
21922-079-06Tretinoin45 g in 1 TUBECREAM454
21922-079-25Tretinoin1 in 1 CARTONCREAM14
21922-079-25Tretinoin20 g in 1 TUBECREAM204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21922-079-06GM - Gram21922-079c316a043-8f60-4000-b0cf-ee2e36b5e60a12025-11-13
21922-079-25GM - Gram21922-0797cfd116c-a6b5-4c2d-b4c7-f8a84db25fdc12025-11-13

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TretinoinTRETINOINEncube Ethicals, Inc.5e3fb8ea-234c-4be2-95a7-d139e069cf982026-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217831
application number: ANDA217831
ndc (product): 21922-079

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106302tretinoin 0.025 % Topical CreamPSN5e3fb8ea-234c-4be2-95a7-d139e069cf984
106303tretinoin 0.05 % Topical CreamPSN5e3fb8ea-234c-4be2-95a7-d139e069cf984
198300tretinoin 0.1 % Topical CreamPSN5e3fb8ea-234c-4be2-95a7-d139e069cf984
106302tretinoin 0.25 MG/ML Topical CreamSCD5e3fb8ea-234c-4be2-95a7-d139e069cf984
106303tretinoin 0.5 MG/ML Topical CreamSCD5e3fb8ea-234c-4be2-95a7-d139e069cf984
198300tretinoin 1 MG/ML Topical CreamSCD5e3fb8ea-234c-4be2-95a7-d139e069cf984
106302tretinoin 0.025 % Topical CreamSY5e3fb8ea-234c-4be2-95a7-d139e069cf984
106303tretinoin 0.05 % Topical CreamSY5e3fb8ea-234c-4be2-95a7-d139e069cf984
198300tretinoin 0.1 % Topical CreamSY5e3fb8ea-234c-4be2-95a7-d139e069cf984

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21922-079-06219220079061 TUBE in 1 CARTON (21922-079-06) / 45 g in 1 TUBE1 tube2025-07-11NoNoCurrent
21922-079-25219220079251 TUBE in 1 CARTON (21922-079-25) / 20 g in 1 TUBE1 tube2025-07-11NoNoCurrent