What is NDC 43386-500?

43386-500 is the product NDC for Famotidine, Famotidine 40 mg/5mL for suspension, listed with the FDA by Lupin Pharmaceuticals,Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Lupin Pharmaceuticals,Inc., NDC labeler code 43386. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Famotidine?

254 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Famotidine NDC 43386-500 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43386-500Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43386-0500Add 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
43386-500-11	43386050011	50 mL in 1 BOTTLE (43386-500-11)Marketed from Dec 17, 2012

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): Famotidine
Generic name (nonproprietary): famotidine
Active ingredients: Famotidine — 40 mg/5mL
Dosage form: For suspension
Route: Oral
Labeler: Lupin Pharmaceuticals,Inc.NDC labeler code 43386
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201695
Marketing start: Dec 17, 2012
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 43386-500_82462011-668a-4fbd-9653-48049901eaccSPL ID 82462011-668a-4fbd-9653-48049901eaccSPL set ID a0bdf4d1-8458-4e4f-95aa-bcc38c0f32f8RxCUI 310274UNII 5QZO15J2Z8UPC 0343386500116
Pharmacologic class: Histamine-2 Receptor Antagonist

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

N443386050011 followed by a unit qualifier and the quantity

Package 43386-0500-11. 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 Nov 21, 2017.

Indications (excerpt from the label)

INDICATIONS AND USAGE Famotidine for Oral Suspension is indicated in: Short-term treatment of active duodenal ulcer. Most adult patients heal within 4 weeks; there is rarely reason to use Famotidine at full dosage for longer than 6 to 8 weeks. Studies have not assessed the safety of famotidine in uncomplicated active duodenal ulcer for periods of more than eight weeks. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer. Controlled studies in adults have not extended beyond one year. Short-term treatment of active benign gastric ulcer. Most adult patients heal within 6 weeks. Studies have not assessed the safety or efficacy of famotidine in unco…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43386-500

What is NDC 43386-500?: 43386-500 is the product NDC for Famotidine, Famotidine 40 mg/5mL for suspension, listed with the FDA by Lupin Pharmaceuticals,Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Famotidine.
What is the active ingredient?: Famotidine.
Who is the labeler?: Lupin Pharmaceuticals,Inc., NDC labeler code 43386. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Famotidine?: 254 other product NDCs are listed under this name. See all 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 Famotidine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Famotidine	Famotidine 40 mg/5mL	Powder, For suspensionOral	NorthStar Rx LLC	72603-564	72603-0564-01
Famotidine	Famotidine 40 mg/5mL	Powder, For suspensionOral	RISING PHARMA HOLDINGS, INC.	64980-737	64980-0737-50
Famotidine	Famotidine 40 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4144	68788-4144-0368788-4144-0468788-4144-06+1 more
Famotidine	Famotidine 20 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0589	80425-0589-0180425-0589-0280425-0589-03
Famotidine	Famotidine 20 mg/1	Tablet, Film coatedOral	Family Dollar Stores, LLC	55319-057	55319-0057-1055319-0057-2555319-0057-50
Famotidine	Famotidine 20 mg/1	Tablet, Film coatedOral	Unit Dose Solutions, Inc.	87441-030	87441-0030-01
Famotidine	Famotidine 20 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-4119	68788-4119-0168788-4119-0368788-4119-04+3 more
Famotidine	Famotidine 20 mg/1	Tablet, Film coatedOral	Safecor Health, LLC	48433-150	48433-0150-20
Famotidine	Famotidine 20 mg/1	Tablet, CoatedOral	Preferred Pharmaceuticals Inc.	68788-4088	68788-4088-0368788-4088-0468788-4088-06+1 more
Famotidine	Famotidine 20 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4574	70518-4574-0070518-4574-0170518-4574-02+1 more

All 255 Famotidine NDCs