What is NDC 85534-0091?

85534-0091 is the product NDC for Famotidine, Famotidine 20 mg/1 tablet, film coated, listed with the FDA by HAWAII REPACK, INC.. It has 4 package NDCs, shown above in 10- and 11-digit form.

HAWAII REPACK, INC., NDC labeler code 85534. 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?

252 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 85534-0091 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)85534-0091Labeler and product segments. Claims need a package NDC.

Product NDC at billing width85534-0091Add 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
85534-0091-0	8553400910085534009100	30 TABLET, FILM COATED in 1 BOTTLE (85534-0091-0)Marketed from Jul 13, 2026
85534-0091-1	8553400910185534009101	60 TABLET, FILM COATED in 1 BOTTLE (85534-0091-1)Marketed from Jul 13, 2026
85534-0091-2	8553400910285534009102	90 TABLET, FILM COATED in 1 BOTTLE (85534-0091-2)Marketed from Jul 13, 2026
85534-0091-3	8553400910385534009103	120 TABLET, FILM COATED in 1 BOTTLE (85534-0091-3)Marketed from Jul 13, 2026

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): Famotidine
Generic name (nonproprietary): famotidine
Active ingredients: Famotidine — 20 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: HAWAII REPACK, INC.NDC labeler code 85534
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215630
Marketing start: Jul 8, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Histamine H2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 85534-0091_567abb69-f223-aaf0-e063-6394a90a4679SPL ID 567abb69-f223-aaf0-e063-6394a90a4679SPL set ID eec89230-47fc-4139-a370-b4f9e225e8c0RxCUI 284245, 310273UNII 5QZO15J2Z8
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

N485534009100 followed by a unit qualifier and the quantity

Package 85534-0091-00. 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 Jul 13, 2026.

Indications (excerpt from the label)

Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: active duodenal ulcer (DU). active gastric ulcer (GU). symptomatic nonerosive gastroesophageal reflux disease (GERD). erosive esophagitis due to GERD, diagnosed by biopsy. Famotidine tablets are indicated in adults for the: treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias). reduction of the risk of duodenal ulcer recurrence. Famotidine is a histamine-2 (H2) receptor antagonist indicated (1) : In adult and pediatric patients 40 kg and greater for the treatment of: active duodenal ulcer (DU). active gastric ulcer. symptomat…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 85534-0091

What is NDC 85534-0091?: 85534-0091 is the product NDC for Famotidine, Famotidine 20 mg/1 tablet, film coated, listed with the FDA by HAWAII REPACK, INC.. It has 4 package NDCs, 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?: HAWAII REPACK, INC., NDC labeler code 85534. 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?: 252 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 253 Famotidine NDCs

Other NDCs under ANDA 215630

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

FDA NDC Directory listings under ANDA 215630
Product	Strength	Form · route	Labeler	Product NDC
Famotidine	Famotidine 20 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4574
Famotidine	Famotidine 40 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2442
Famotidine	Famotidine 20 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7829
Famotidine	Famotidine 40 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-345
Famotidine	Famotidine 40 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4084
Famotidine	Famotidine 40 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-3584
Famotidine	Famotidine 20 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8485
Famotidine	Famotidine 40 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-9724
Famotidine	Famotidine 40 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-453
Famotidine	Famotidine 40 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8518
Famotidine	Famotidine 40 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7981
Famotidine	Famotidine 40 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7982
Famotidine	Famotidine 40 mg/1	Tablet, Film coatedOral	HAWAII REPACK, INC.	85534-0092
Famotidine	Famotidine 20 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-9748
Famotidine	Famotidine 20 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-842
Famotidine	Famotidine 20 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3829
Famotidine	Famotidine 40 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-843
Famotidine	Famotidine 40 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-889
Famotidine	Famotidine 40 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-713
Famotidine	Famotidine 20 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-712

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