NDC codes

FDA NDC Directory
Product NDC (as listed)59651-825Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59651-0825Add 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
59651-825-015965108250159651082501100 TABLET, FILM COATED in 1 BOTTLE (59651-825-01)Marketed from Nov 12, 2024
59651-825-055965108250559651082505500 TABLET, FILM COATED in 1 BOTTLE (59651-825-05)Marketed from Nov 12, 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)
Cimetidine
Generic name (nonproprietary)
cimetidine
Active ingredients
Cimetidine — 400 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Aurobindo Pharma LimitedNDC labeler code 59651
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 218997
Marketing start
Listing expires
Other FDA classes
Histamine H2 Receptor Antagonists (Mechanism)
Identifiers
Product ID 59651-825_ebd53065-c080-4045-a398-64d3f3b1460fSPL ID ebd53065-c080-4045-a398-64d3f3b1460fSPL set ID ebd53065-c080-4045-a398-64d3f3b1460fRxCUI 197505, 197506, 197507, 197508UNII 80061L1WGD

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

N459651082501 followed by a unit qualifier and the quantity

Package 59651-0825-01. 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 .

Indications (excerpt from the label)

INDICATIONS AND USAGE Cimetidine tablets are indicated in: 1. Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks and there is rarely reason to use cimetidine tablets at full dosage for longer than 6 to 8 weeks (see DOSAGE AND ADMINISTRATION: Duodenal Ulcer ). Concomitant antacids should be given as needed for relief of pain. However, simultaneous administration of cimetidine tablets and antacids is not recommended, since antacids have been reported to interfere with the absorption of cimetidine. 2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer. Patients have been maintained on continued treatment with cimetidine …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 59651-825

What is NDC 59651-825?
59651-825 is the product NDC for Cimetidine, Cimetidine 400 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Cimetidine.
What is the active ingredient?
Cimetidine.
Who is the labeler?
Aurobindo Pharma Limited, NDC labeler code 59651. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cimetidine?
21 other product NDCs are listed under this name. See all Cimetidine 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 Cimetidine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
CimetidineCimetidine 200 mg/1Tablet, Film coatedOralBionpharma Inc.69452-32369452-0323-2069452-0323-30
CimetidineCimetidine 300 mg/1Tablet, Film coatedOralBionpharma Inc.69452-32469452-0324-2069452-0324-30
CimetidineCimetidine 400 mg/1Tablet, Film coatedOralBionpharma Inc.69452-32569452-0325-2069452-0325-30
CimetidineCimetidine 800 mg/1Tablet, Film coatedOralBionpharma Inc.69452-32669452-0326-2069452-0326-30
CimetidineCimetidine 800 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-82659651-0826-01
CimetidineCimetidine 400 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-69751655-0697-51
CimetidineCimetidine 400 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-050050090-0500-0050090-0500-01
CimetidineCimetidine 400 mg/1Tablet, Film coatedOralProficient Rx LP63187-33363187-0333-30
CimetidineCimetidine 800 mg/1Tablet, Film coatedOralTeva Pharmaceuticals USA, Inc.0093-830500093-8305-01
CimetidineCimetidine 300 mg/1Tablet, Film coatedOralTeva Pharmaceuticals USA, Inc.0093-819200093-8192-0100093-8192-05

All 22 Cimetidine NDCs

Other NDCs under ANDA 218997

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

FDA NDC Directory listings under ANDA 218997
ProductStrengthForm · routeLabelerProduct NDC
CimetidineCimetidine 800 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-826

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