What is NDC 72578-214?

72578-214 is the product NDC for Ibuprofen and Famotidine, Ibuprofen 800 mg/1; Famotidine 26.6 mg/1 tablet, listed with the FDA by Viona Pharmaceuticals Inc. It has 1 package NDC, shown above in 10- and 11-digit form.

Viona Pharmaceuticals Inc, NDC labeler code 72578. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Ibuprofen and Famotidine?

18 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Ibuprofen and Famotidine NDC 72578-214

NDC codes

FDA NDC Directory

Product NDC (as listed)72578-214Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72578-0214Add 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
72578-214-16	7257802141672578021416	90 TABLET in 1 BOTTLE (72578-214-16)Marketed from Jun 1, 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): Ibuprofen and Famotidine
Generic name (nonproprietary): ibuprofen and famotidine
Active ingredients: Ibuprofen — 800 mg/1Famotidine — 26.6 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Viona Pharmaceuticals IncNDC labeler code 72578
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218684
Marketing start: Jun 1, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Histamine H2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 72578-214_d0498b4c-d60a-4a93-b151-d3bc4658787aSPL ID d0498b4c-d60a-4a93-b151-d3bc4658787aSPL set ID 66524c84-35bc-4e7f-897a-f63fa4bca432RxCUI 1100066UNII WK2XYI10QM, 5QZO15J2Z8
Pharmacologic class: Histamine-2 Receptor Antagonist; Nonsteroidal Anti-inflammatory Drug

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

N472578021416 followed by a unit qualifier and the quantity

Package 72578-0214-16. 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 May 28, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Ibuprofen and famotidine tablets, a combination of the NSAID ibuprofen and the histamine H 2 -receptor antagonist famotidine, is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer. Controlled trials do not extend beyond 6 months [see Clinical Studies ( 14 ), Use in Specific Populations ( 8.5 )]. Ibuprofen and famotidine tablets,…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72578-214

What is NDC 72578-214?: 72578-214 is the product NDC for Ibuprofen and Famotidine, Ibuprofen 800 mg/1; Famotidine 26.6 mg/1 tablet, listed with the FDA by Viona Pharmaceuticals Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Ibuprofen and Famotidine.
What is the active ingredient?: Ibuprofen, Famotidine.
Who is the labeler?: Viona Pharmaceuticals Inc, NDC labeler code 72578. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ibuprofen and Famotidine?: 18 other product NDCs are listed under this name. See all Ibuprofen and Famotidine 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 Ibuprofen and Famotidine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Ibuprofen and Famotidine	Ibuprofen 800 mg/1; Famotidine 26.6 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0587	80425-0587-0180425-0587-0280425-0587-03
Ibuprofen and famotidine	Ibuprofen 800 mg/1; Famotidine 26.6 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4580	70518-4580-00
Ibuprofen and famotidine	Ibuprofen 800 mg/1; Famotidine 26.6 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8897	68788-8897-09
Ibuprofen and famotidine	Ibuprofen 800 mg/1; Famotidine 26.6 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	59651-908	59651-0908-90
Ibuprofen and Famotidine	Ibuprofen 800 mg/1; Famotidine 26.6 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1924	70771-1924-09
Ibuprofen and famotidine	Ibuprofen 800 mg/1; Famotidine 26.6 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0422	80425-0422-0180425-0422-0280425-0422-03
Ibuprofen And Famotidine	Ibuprofen 800 mg/1; Famotidine 26.6 mg/1	TabletOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0384	80425-0384-0180425-0384-0280425-0384-03
Ibuprofen and famotidine	Ibuprofen 800 mg/1; Famotidine 26.6 mg/1	TabletOral	Par Health USA, LLC	49884-366	49884-0366-09
Ibuprofen and famotidine	Ibuprofen 800 mg/1; Famotidine 26.6 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0483	80425-0483-0180425-0483-0280425-0483-03
Ibuprofen And Famotidine	Ibuprofen 800 mg/1; Famotidine 26.6 mg/1	TabletOral	Camber Pharmaceuticals, Inc.	31722-315	31722-0315-90

All 19 Ibuprofen and Famotidine NDCs

Other NDCs under ANDA 218684

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

FDA NDC Directory listings under ANDA 218684
Product	Strength	Form · route	Labeler	Product NDC
Ibuprofen and Famotidine	Ibuprofen 800 mg/1; Famotidine 26.6 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1924
Ibuprofen and Famotidine	Ibuprofen 800 mg/1; Famotidine 26.6 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0587
Ibuprofen Famotidine	Ibuprofen 800 mg/1; Famotidine 26.6 mg/1	TabletOral	Direct_Rx	72189-667