NDC codes

FDA NDC Directory
Product NDC (as listed)68071-3521Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68071-3521Add 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 NDC11-digit (billing)PackageCopy
68071-3521-3680713521036807135210330 TABLET, FILM COATED in 1 BOTTLE (68071-3521-3)Marketed from Oct 12, 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)
Famotidine
Generic name (nonproprietary)
famotidine
Active ingredients
Famotidine — 40 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
NuCare Pharmaceuticals,Inc.NDC labeler code 68071
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 216441
Marketing start
Listing expires
Other FDA classes
Histamine H2 Receptor Antagonists (Mechanism)
Identifiers
Product ID 68071-3521_2d3f8242-1bd2-44b6-e063-6394a90a1a32SPL ID 2d3f8242-1bd2-44b6-e063-6394a90a1a32SPL set ID 0786d7f5-85a7-d835-e063-6394a90ad719RxCUI 284245UNII 5QZO15J2Z8UPC 0368071352139

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

N468071352103 followed by a unit qualifier and the quantity

Package 68071-3521-03. 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 .

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 (H 2 ) receptor antagonist indicated ( 1 ): In adult and pediatric patients 40 kg and greater for the treatment of: active duodenal ulcer (DU). active gastric ulcer. sympto…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68071-3521

What is NDC 68071-3521?
68071-3521 is the product NDC for Famotidine, Famotidine 40 mg/1 tablet, film coated, listed with the FDA by NuCare 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?
NuCare Pharmaceuticals,Inc., NDC labeler code 68071. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
FamotidineFamotidine 40 mg/5mLPowder, For suspensionOralNorthStar Rx LLC72603-56472603-0564-01
FamotidineFamotidine 40 mg/5mLPowder, For suspensionOralRISING PHARMA HOLDINGS, INC.64980-73764980-0737-50
FamotidineFamotidine 40 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-414468788-4144-0368788-4144-0468788-4144-06+1 more
FamotidineFamotidine 20 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-058980425-0589-0180425-0589-0280425-0589-03
FamotidineFamotidine 20 mg/1Tablet, Film coatedOralFamily Dollar Stores, LLC55319-05755319-0057-1055319-0057-2555319-0057-50
FamotidineFamotidine 20 mg/1Tablet, Film coatedOralUnit Dose Solutions, Inc.87441-03087441-0030-01
FamotidineFamotidine 20 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-411968788-4119-0168788-4119-0368788-4119-04+3 more
FamotidineFamotidine 20 mg/1Tablet, Film coatedOralSafecor Health, LLC48433-15048433-0150-20
FamotidineFamotidine 20 mg/1Tablet, CoatedOralPreferred Pharmaceuticals Inc.68788-408868788-4088-0368788-4088-0468788-4088-06+1 more
FamotidineFamotidine 20 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-457470518-4574-0070518-4574-0170518-4574-02+1 more

All 253 Famotidine NDCs

Other NDCs under ANDA 216441

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

FDA NDC Directory listings under ANDA 216441
ProductStrengthForm · routeLabelerProduct NDC
FamotidineFamotidine 20 mg/1Tablet, Film coatedOralSafecor Health, LLC48433-150
FamotidineFamotidine 40 mg/1Tablet, Film coatedOralSt. Mary's Medical Park Pharmacy60760-736
FamotidineFamotidine 20 mg/1Tablet, Film coatedOralZydus Pharmaceuticals USA Inc.70710-1683
FamotidineFamotidine 40 mg/1Tablet, Film coatedOralZydus Pharmaceuticals USA Inc.70710-1684
FamotidineFamotidine 20 mg/1Tablet, Film coatedOralZydus Lifesciences Limited70771-1702
FamotidineFamotidine 40 mg/1Tablet, Film coatedOralZydus Lifesciences Limited70771-1703
FamotidineFamotidine 20 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2190
FamotidineFamotidine 40 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-9615

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