Ibuprofen and famotidine NDC 63629-8891

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-8891Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-8891Add 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
63629-8891-1	63629889101	30 TABLET, FILM COATED in 1 BOTTLE (63629-8891-1)Marketed from Oct 26, 2021
63629-8891-2	63629889102	90 TABLET, FILM COATED in 1 BOTTLE (63629-8891-2)Marketed from Apr 8, 2022
63629-8891-3	63629889103	60 TABLET, FILM COATED in 1 BOTTLE (63629-8891-3)Marketed from Sep 15, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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, Film coated
Route: Oral
Labeler: Bryant Ranch Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211890
Marketing start: Aug 4, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Histamine H2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 63629-8891_eecdc3bf-cc98-4db0-a94f-7ba1b1830548SPL ID eecdc3bf-cc98-4db0-a94f-7ba1b1830548SPL set ID ee69d3cb-dc95-410c-a7c8-6623073a923dRxCUI 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

N463629889101 followed by a unit qualifier and the quantity

Package 63629-8891-01. 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 8, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Ibuprofen and famotidine tablet, 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 tablet, …

Excerpt only. Read the full label for complete information.

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