What is NDC 0378-8082?

0378-8082 is the product NDC for Tretinoin, Tretinoin .25 mg/g cream, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tretinoin NDC 0378-8082 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-8082Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-8082Add 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 NDC	11-digit (billing)	Package	Copy
0378-8082-20	0037880822000378808220	1 TUBE in 1 CARTON (0378-8082-20) / 20 g in 1 TUBEMarketed from Apr 29, 2019
0378-8082-45	0037880824500378808245	1 TUBE in 1 CARTON (0378-8082-45) / 45 g in 1 TUBEMarketed from Apr 3, 2019

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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: Cream
Route: Topical
Labeler: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 019049
Marketing start: Apr 3, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Retinoids (Chemical structure)
Identifiers: Product ID 0378-8082_96edaee2-b74e-4f7b-947f-1addc75402eaSPL ID 96edaee2-b74e-4f7b-947f-1addc75402eaSPL set ID ba377a5e-e48a-4bd9-9d76-929d70793396RxCUI 106302, 106303, 198300, 313450, 313451UNII 5688UTC01RUPC 0303788082450, 0303788083457, 0303788086151
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

N400378808220 followed by a unit qualifier and the quantity

Package 00378-8082-20. 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 Oct 9, 2024.

Indications (excerpt from the label)

Indications and Usage Tretinoin 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 0378-8082

What is NDC 0378-8082?: 0378-8082 is the product NDC for Tretinoin, Tretinoin .25 mg/g cream, listed with the FDA by Mylan Pharmaceuticals 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?: Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Tretinoin	Tretinoin .25 mg/g	CreamTopical	Zydus Lifesciences Limited	70771-1933	70771-1933-0270771-1933-04
Tretinoin	Tretinoin .25 mg/g	CreamTopical	Viona Pharmaceuticals Inc	72578-155	72578-0155-0872578-0155-09
Tretinoin	Tretinoin .5 mg/g	CreamTopical	Alembic Pharmaceuticals Limited	46708-808	46708-0808-0046708-0808-20
Tretinoin	Tretinoin .5 mg/g	CreamTopical	Alembic Pharmaceuticals Inc.	62332-808	62332-0808-2062332-0808-45
Tretinoin	Tretinoin .8 mg/g	GelTopical	Amneal Pharmaceuticals NY LLC	69238-2323	69238-2323-01
Tretinoin	Tretinoin .6 mg/g	GelTopical	Encube Ethicals, Inc.	21922-042	21922-0042-40
Tretinoin	Tretinoin .5 mg/g	CreamTopical	Encube Ethicals, Inc.	21922-078	21922-0078-0621922-0078-25
Tretinoin	Tretinoin 1 mg/g	CreamTopical	Encube Ethicals, Inc.	21922-077	21922-0077-0621922-0077-25
Tretinoin	Tretinoin .25 mg/g	CreamTopical	Preferred Pharmaceuticals Inc.	68788-4069	68788-4069-02
Tretinoin	Tretinoin .25 mg/g	CreamTopical	Alembic Pharmaceuticals Limited	46708-809	46708-0809-2046708-0809-45

All 69 Tretinoin NDCs

Other NDCs under NDA 019049

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 019049
Product	Strength	Form · route	Labeler	Product NDC
Retin-Atretinoin	Tretinoin .25 mg/g	CreamTopical	Bausch Health US, LLC	0187-5160
Tretinoin Creamtretinoin	Tretinoin .25 mg/g	CreamTopical	Obagi Cosmeceuticals LLC	62032-414