Diclofenac Sodium Misoprostol NDC 75834-264

NDC codes

FDA NDC Directory

Product NDC (as listed)75834-264Labeler and product segments. Claims need a package NDC.

Product NDC at billing width75834-0264Add 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
75834-264-60	75834026460	60 TABLET, DELAYED RELEASE in 1 BOTTLE (75834-264-60)Marketed from Jul 15, 2021
75834-264-90	75834026490	90 TABLET, DELAYED RELEASE in 1 BOTTLE (75834-264-90)Marketed from Jul 15, 2021

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): Diclofenac Sodium Misoprostol
Generic name (nonproprietary): diclofenac sodium and misoprostol
Active ingredients: Diclofenac sodium — 50 mg/1Misoprostol — 200 ug/1
Dosage form: Tablet, Delayed release
Route: Oral
Labeler: Nivagen Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205143
Marketing start: Jul 15, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)Synthetic (Chemical structure)
Identifiers: Product ID 75834-264_542fd9dd-a6d3-4432-9e7a-2ca5bce12956SPL ID 542fd9dd-a6d3-4432-9e7a-2ca5bce12956SPL set ID 2acf46ac-8ba8-444d-b421-19d5ad49644cRxCUI 857706, 1359105UNII 0E43V0BB57, QTG126297QUPC 0375834264608, 0375834265605
Pharmacologic class: Nonsteroidal Anti-inflammatory Drug; Prostaglandin E1 Analog

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

N475834026460 followed by a unit qualifier and the quantity

Package 75834-0264-60. 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

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