Prescription drug · ANDA

Diclofenac Sodium NDC 72888-109

Diclofenac sodium 25 mg/1 · Tablet, Delayed release · Oral · Advagen Pharma Ltd

NDC codes

FDA NDC Directory
Product NDC (as listed)72888-109Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72888-0109Add 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
72888-109-00728880109001000 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-109-00)Marketed from Jun 1, 2023
72888-109-0172888010901100 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-109-01)Marketed from Jun 1, 2023
72888-109-0572888010905500 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-109-05)Marketed from Aug 1, 2023
72888-109-307288801093030 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-109-30)Marketed from Jun 1, 2023
72888-109-607288801096060 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-109-60)Marketed from Jun 1, 2023

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
Generic name (nonproprietary)
diclofenac sodium
Active ingredients
Diclofenac sodium — 25 mg/1
Dosage form
Tablet, Delayed release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 216548
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
Identifiers
Product ID 72888-109_3904a832-bc2f-1d96-e063-6294a90a0cd0SPL ID 3904a832-bc2f-1d96-e063-6294a90a0cd0SPL set ID ac2b4060-a5da-4ddf-a734-2ff58a1f98c9RxCUI 855664, 855906, 855926UNII QTG126297QUPC 0372888110608, 0372888111001, 0372888110059, 0372888111056, 0372888109015, 0372888109008, 0372888110301, 0372888111308, 0372888109602, 0372888110004, 0372888111605, 0372888109053, 0372888109305, 0372888110011, 0372888111018

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

N472888010900 followed by a unit qualifier and the quantity

Package 72888-0109-00. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation ). Diclofenac sodium delayed-release tablets are indicated: for relief of the signs and symptoms of osteoarthritis for relief of the signs and symptoms of rheumatoid arthritis for acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 216548

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

FDA NDC Directory listings under ANDA 216548
ProductStrengthForm · routeLabelerProduct NDC
Diclofenac SodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralA-S Medication Solutions50090-7646
Diclofenac SodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralA-S Medication Solutions50090-7647
Diclofenac SodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralRedpharm Drug67296-2151
Diclofenac SodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralBryant Ranch Prepack71335-2684
Diclofenac SodiumDiclofenac sodium 50 mg/1Tablet, Delayed releaseOralAdvagen Pharma Ltd72888-110
Diclofenac SodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralAdvagen Pharma Ltd72888-111
Diclofenac SodiumDiclofenac sodium 25 mg/1Tablet, Delayed releaseOralNorthStar Rx LLC72603-600
Diclofenac SodiumDiclofenac sodium 50 mg/1Tablet, Delayed releaseOralNorthStar Rx LLC72603-601
Diclofenac SodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralNorthStar Rx LLC72603-604

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Diclofenac Sodium NDC 72888-109 | Med-Code