NDC codes

FDA NDC Directory
Product NDC (as listed)21922-057Labeler and product segments. Claims need a package NDC.
Product NDC at billing width21922-0057Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
21922-057-0421922005704219220057041 TUBE in 1 CARTON (21922-057-04) / 15 g in 1 TUBEMarketed from Mar 6, 2025
21922-057-0621922005706219220057061 TUBE in 1 CARTON (21922-057-06) / 45 g in 1 TUBEMarketed from Mar 6, 2025

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Tretinoin
Generic name (nonproprietary)
tretinoin
Active ingredients
Tretinoin — .25 mg/g
Dosage form
Gel
Route
Topical
Labeler
Encube Ethicals, Inc.NDC labeler code 21922
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 217587
Marketing start
Listing expires
Other FDA classes
Retinoids (Chemical structure)
Identifiers
Product ID 21922-057_09404f33-7d64-49aa-831d-7bb2e2fe3c9aSPL ID 09404f33-7d64-49aa-831d-7bb2e2fe3c9aSPL set ID b61f6b02-6171-4da8-94eb-bcd4808dd918RxCUI 313450, 313451UNII 5688UTC01RUPC 0321922056044, 0321922057041
Pharmacologic class
Retinoid

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N421922005704 followed by a unit qualifier and the quantity

Package 21922-0057-04. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

INDICATIONS AND USAGE Tretinoin gel is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 21922-057

What is NDC 21922-057?
21922-057 is the product NDC for Tretinoin, Tretinoin .25 mg/g gel, listed with the FDA by Encube Ethicals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Tretinoin.
What is the active ingredient?
Tretinoin.
Who is the labeler?
Encube Ethicals, Inc., NDC labeler code 21922. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tretinoin?
68 other product NDCs are listed under this name. See all Tretinoin NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Tretinoin NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
TretinoinTretinoin .25 mg/gCreamTopicalZydus Lifesciences Limited70771-193370771-1933-0270771-1933-04
TretinoinTretinoin .25 mg/gCreamTopicalViona Pharmaceuticals Inc72578-15572578-0155-0872578-0155-09
TretinoinTretinoin .5 mg/gCreamTopicalAlembic Pharmaceuticals Limited46708-80846708-0808-0046708-0808-20
TretinoinTretinoin .5 mg/gCreamTopicalAlembic Pharmaceuticals Inc.62332-80862332-0808-2062332-0808-45
TretinoinTretinoin .8 mg/gGelTopicalAmneal Pharmaceuticals NY LLC69238-232369238-2323-01
TretinoinTretinoin .6 mg/gGelTopicalEncube Ethicals, Inc.21922-04221922-0042-40
TretinoinTretinoin .5 mg/gCreamTopicalEncube Ethicals, Inc.21922-07821922-0078-0621922-0078-25
TretinoinTretinoin 1 mg/gCreamTopicalEncube Ethicals, Inc.21922-07721922-0077-0621922-0077-25
TretinoinTretinoin .25 mg/gCreamTopicalPreferred Pharmaceuticals Inc.68788-406968788-4069-02
TretinoinTretinoin .25 mg/gCreamTopicalAlembic Pharmaceuticals Limited46708-80946708-0809-2046708-0809-45

All 69 Tretinoin NDCs

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