NDC codes

FDA NDC Directory
Product NDC (as listed)0093-8192Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00093-8192Add 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
0093-8192-0100093819201100 TABLET, FILM COATED in 1 BOTTLE (0093-8192-01)Marketed from Nov 24, 2003
0093-8192-0500093819205500 TABLET, FILM COATED in 1 BOTTLE (0093-8192-05)Marketed from Jan 28, 2004

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
Cimetidine300 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 074151
Marketing start
Listing expires
Other FDA classes
Histamine H2 Receptor Antagonists (Mechanism)
Identifiers
Product ID 0093-8192_e1f40596-aa5b-46a4-b2aa-add1150ac3a1SPL ID e1f40596-aa5b-46a4-b2aa-add1150ac3a1SPL set ID 496e258d-a5fd-42da-9a86-73afc8be359bRxCUI 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

N400093819201 followed by a unit qualifier and the quantity

Package 00093-8192-01. 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 USP are indicated in: Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks and there is rarely reason to use cimetidine 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 oral cimetidine and antacids is not recommended, since antacids have been reported to interfere with the absorption of oral cimetidine. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer. Patients have been maintained on continued treatment with cimetidine 400 mg

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 074151

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

FDA NDC Directory listings under ANDA 074151
ProductStrengthForm · routeLabelerProduct NDC
CimetidineCimetidine 400 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-0500
CimetidineCimetidine 400 mg/1Tablet, Film coatedOralProficient Rx LP63187-333
CimetidineCimetidine 400 mg/1Tablet, Film coatedOralTeva Pharmaceuticals USA, Inc.0093-8204
CimetidineCimetidine 300 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-1783

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