What is NDC 82804-033?

82804-033 is the product NDC for Mycophenolate mofetil, Mycophenolate mofetil 500 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.

Proficient Rx LP, NDC labeler code 82804. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Mycophenolate mofetil?

57 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Mycophenolate mofetil NDC 82804-033

NDC codes

FDA NDC Directory

Product NDC (as listed)82804-033Labeler and product segments. Claims need a package NDC.

Product NDC at billing width82804-0033Add 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
82804-033-30	8280400333082804003330	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-033-30)Marketed from Oct 25, 2023
82804-033-60	8280400336082804003360	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-033-60)Marketed from Oct 25, 2023
82804-033-90	8280400339082804003390	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-033-90)Marketed from Oct 25, 2023

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): Mycophenolate mofetil
Generic name (nonproprietary): mycophenolate mofetil
Active ingredients: Mycophenolate mofetil — 500 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Proficient Rx LPNDC labeler code 82804
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090456
Marketing start: Oct 15, 2022
Listing expires: Dec 31, 2027
Identifiers: Product ID 82804-033_ce06afcb-4e6c-4b78-8bad-9909c8fffa52SPL ID ce06afcb-4e6c-4b78-8bad-9909c8fffa52SPL set ID ce06afcb-4e6c-4b78-8bad-9909c8fffa52RxCUI 200060UNII 9242ECW6R0UPC 0382804033300
Pharmacologic class: Antimetabolite Immunosuppressant

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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N482804003330 followed by a unit qualifier and the quantity

Package 82804-0033-30. 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 1, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)] , heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)] , in combination with other immunosuppressants. Mycophenolate mofetil is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants. (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 82804-033

What is NDC 82804-033?: 82804-033 is the product NDC for Mycophenolate mofetil, Mycophenolate mofetil 500 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Mycophenolate mofetil.
What is the active ingredient?: Mycophenolate mofetil.
Who is the labeler?: Proficient Rx LP, NDC labeler code 82804. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Mycophenolate mofetil?: 57 other product NDCs are listed under this name. See all Mycophenolate mofetil 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 Mycophenolate mofetil NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
mycophenolate mofetil	Mycophenolate mofetil 250 mg/1	CapsuleOral	Cardinal Health 107, LLC	55154-0161	55154-0161-00
Mycophenolate Mofetil	Mycophenolate mofetil 200 mg/mL	Powder, For suspensionOral	Strides Pharma Science Limited	64380-899	64380-0899-00
Mycophenolate Mofetil	Mycophenolate mofetil 200 mg/mL	Powder, For suspensionOral	QUAGEN PHARMACEUTICALS LLC	70752-294	70752-0294-60
Mycophenolate Mofetil	Mycophenolate mofetil 200 mg/mL	Powder, For suspensionOral	NorthStar Rx LLC	72603-751	72603-0751-01
mycophenolate mofetil	Mycophenolate mofetil 250 mg/1	CapsuleOral	Major Pharmaceuticals	0904-7466	00904-7466-61
Mycophenolate Mofetil	Mycophenolate mofetil 250 mg/1	CapsuleOral	Wuxi Fortune Pharmaceutical Co.,Ltd.	65050-2073	65050-2073-00
Mycophenolate mofetil	Mycophenolate mofetil 500 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4377	70518-4377-00
Mycophenolate mofetil	Mycophenolate mofetil 250 mg/1	CapsuleOral	AvKARE	73190-009	73190-0009-0173190-0009-50
Mycophenolate mofetil	Mycophenolate mofetil 500 mg/1	Tablet, Film coatedOral	AvKARE	73190-010	73190-0010-0173190-0010-50
mycophenolate mofetil	Mycophenolate mofetil 250 mg/1	CapsuleOral	American Health Packaging	60687-885	60687-0885-01

All 58 Mycophenolate mofetil NDCs

Other NDCs under ANDA 090456

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

FDA NDC Directory listings under ANDA 090456
Product	Strength	Form · route	Labeler	Product NDC
Mycophenolate mofetil	Mycophenolate mofetil 500 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-7078
Mycophenolate mofetil	Mycophenolate mofetil 500 mg/1	Tablet, Film coatedOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-836
Mycophenolate mofetil	Mycophenolate mofetil 500 mg/1	Tablet, Film coatedOral	Strides Pharma Inc.	42543-989
Mycophenolate mofetil	Mycophenolate mofetil 500 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-3571
Mycophenolate mofetil	Mycophenolate mofetil 500 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-438
Mycophenolate mofetil	Mycophenolate mofetil 500 mg/1	Tablet, Film coatedOral	Strides Pharma Science Limited	64380-725
Mycophenolate mofetil	Mycophenolate mofetil 500 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals, Inc.	68071-3767
Mycophenolate mofetil	Mycophenolate mofetil 500 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-2767
Mycophenolate mofetil	Mycophenolate mofetil 500 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4377
Mycophenolate mofetil	Mycophenolate mofetil 500 mg/1	Tablet, Film coatedOral	AvKARE	73190-010