What is NDC 0378-8090?

0378-8090 is the product NDC for Tretinoin, Tretinoin .5 mg/g gel, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, 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 0378-8090 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-8090Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-8090Add 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
0378-8090-45	0037880904500378809045	1 TUBE in 1 CARTON (0378-8090-45) / 45 g in 1 TUBEMarketed from Nov 14, 2018

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 — .5 mg/g
Dosage form: Gel
Route: Topical
Labeler: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207955
Marketing start: Nov 14, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Retinoids (Chemical structure)
Identifiers: Product ID 0378-8090_7f967c10-776a-4b9c-aeda-70276ff2747fSPL ID 7f967c10-776a-4b9c-aeda-70276ff2747fSPL set ID ce5f4f14-5e60-4cc1-bcb3-1fa9b8aa9cd5RxCUI 245723UNII 5688UTC01R
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

N400378809045 followed by a unit qualifier and the quantity

Package 00378-8090-45. 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 Jul 25, 2022.

Indications (excerpt from the label)

Tretinoin gel is indicated for topical treatment of acne vulgaris. Tretinoin gel is a retinoid indicated for topical treatment of acne vulgaris ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0378-8090

What is NDC 0378-8090?: 0378-8090 is the product NDC for Tretinoin, Tretinoin .5 mg/g gel, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, 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