What is NDC 49884-366?

49884-366 is the product NDC for Ibuprofen and famotidine, Ibuprofen 800 mg/1; Famotidine 26.6 mg/1 tablet, listed with the FDA by Par Health USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Par Health USA, LLC, NDC labeler code 49884. 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 49884-366

NDC codes

FDA NDC Directory

Product NDC (as listed)49884-366Labeler and product segments. Claims need a package NDC.

Product NDC at billing width49884-0366Add 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
49884-366-09	4988403660949884036609	90 TABLET in 1 BOTTLE (49884-366-09)Marketed from Mar 22, 2024

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: Par Health USA, LLCNDC labeler code 49884
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203658
Marketing start: Mar 22, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Histamine H2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 49884-366_42b48d54-e6f0-496b-8452-bf604b66b4bbSPL ID 42b48d54-e6f0-496b-8452-bf604b66b4bbSPL set ID b6895176-efb1-472e-8b6f-2987e8e67684RxCUI 1100066UNII WK2XYI10QM, 5QZO15J2Z8UPC 0349884366094
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

N449884036609 followed by a unit qualifier and the quantity

Package 49884-0366-09. 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 10, 2024. 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 49884-366

What is NDC 49884-366?: 49884-366 is the product NDC for Ibuprofen and famotidine, Ibuprofen 800 mg/1; Famotidine 26.6 mg/1 tablet, listed with the FDA by Par Health USA, LLC. 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?: Par Health USA, LLC, NDC labeler code 49884. 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	TabletOral	Viona Pharmaceuticals Inc	72578-214	72578-0214-16
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	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 203658

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

FDA NDC Directory listings under ANDA 203658
Product	Strength	Form · route	Labeler	Product NDC
Ibuprofen and famotidine	Ibuprofen 800 mg/1; Famotidine 26.6 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0483