Prescription drug · ANDA

Diclofenac Sodium Delayed Release NDC 61442-227

diclofenac sodium · Diclofenac sodium 75 mg/1 · Tablet, Delayed release · Oral · Carlsbad Technology, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)61442-227Labeler and product segments. Claims need a package NDC.
Product NDC at billing width61442-0227Add 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
61442-227-0161442022701100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (61442-227-01)Marketed from Mar 28, 2025
61442-227-0561442022705500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (61442-227-05)Marketed from Mar 28, 2025
61442-227-10614420227101000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (61442-227-10)Marketed from Mar 28, 2025
61442-227-606144202276060 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (61442-227-60)Marketed from Mar 28, 2025

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 Delayed ReleaseSuffix: Delayed Release
Generic name (nonproprietary)
diclofenac sodium
Active ingredients
Diclofenac sodium — 75 mg/1
Dosage form
Tablet, Delayed release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075185
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
Identifiers
Product ID 61442-227_363745c4-873f-ad20-e063-6394a90a8a84SPL ID 363745c4-873f-ad20-e063-6394a90a8a84SPL set ID 363764a0-e0a8-3e3f-e063-6294a90ad672RxCUI 855664, 855906, 855926UNII QTG126297QUPC 0361442227609, 0361442226602

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

N461442022701 followed by a unit qualifier and the quantity

Package 61442-0227-01. 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 . 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. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals ( see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation ). Diclofenac is 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 075185

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

FDA NDC Directory listings under ANDA 075185
ProductStrengthForm · routeLabelerProduct NDC
Diclofenac Sodium Delayed Releasediclofenac sodiumDiclofenac sodium 50 mg/1Tablet, Delayed releaseOralREMEDYREPACK INC.70518-0756
Diclofenac Sodium Delayed Releasediclofenac sodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralProficient Rx LP63187-222
Diclofenac Sodium Delayed Releasediclofenac sodiumDiclofenac sodium 50 mg/1Tablet, Delayed releaseOralGolden State Medical Supply, Inc.51407-967
Diclofenac Sodium Delayed Releasediclofenac sodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralGolden State Medical Supply, Inc.51407-968
Diclofenac Sodium DRdiclofenac sodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0189
Diclofenac Sodium Delayed Releasediclofenac sodiumDiclofenac sodium 50 mg/1Tablet, Delayed releaseOralA-S Medication Solutions50090-0542
Diclofenac Sodium DRdiclofenac sodiumDiclofenac sodium 50 mg/1Tablet, Delayed releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0197
Diclofenac Sodium Delayed Releasediclofenac sodiumDiclofenac sodium 50 mg/1Tablet, Delayed releaseOralA-S Medication Solutions50090-0543
Diclofenac Sodium Delayed Releasediclofenac sodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralA-S Medication Solutions50090-0545
Diclofenac Sodium Delayed Releasediclofenac sodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralBryant Ranch Prepack71335-0357
Diclofenac Sodium Delayed Releasediclofenac sodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralREMEDYREPACK INC.70518-0627
Diclofenac Sodium D/RDiclofenac sodium 50 mg/1Tablet, Delayed releaseOralDirectRx72189-675
Diclofenac Sodium Delayed Releasediclofenac sodiumDiclofenac sodium 50 mg/1Tablet, Delayed releaseOralCarlsbad Technology, Inc.61442-102
Diclofenac Sodium Delayed Releasediclofenac sodiumDiclofenac sodium 25 mg/1Tablet, Delayed releaseOralCarlsbad Technology, Inc.61442-101
Diclofenac Sodium Delayed Releasediclofenac sodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralCarlsbad Technology, Inc.61442-103
Diclofenac SodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralAvKARE42291-231
Diclofenac Sodium Delayed Releasediclofenac sodiumDiclofenac sodium 50 mg/1Tablet, Delayed releaseOralNuCare Pharmaceuticals, Inc.68071-3184
Diclofenac SodiumDiclofenac sodium 50 mg/1Tablet, Delayed releaseOralAvKARE42291-230
Diclofenac Sodium Delayed Releasediclofenac sodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralPHOENIX RX LLC85509-1103
Diclofenac Sodium Delayed Releasediclofenac sodiumDiclofenac sodium 50 mg/1Tablet, Delayed releaseOralCarlsbad Technology, Inc.61442-226

Showing 20 of 39.

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in
Diclofenac Sodium Delayed Release NDC 61442-227 | Med-Code