NDC codes

FDA NDC Directory
Product NDC (as listed)50090-4172Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-4172Add 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
50090-4172-15009041720130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-4172-1)Marketed from Mar 7, 2019

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 100 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075492
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
Identifiers
Product ID 50090-4172_2915e90c-21e3-44ba-97cf-a7ccf8f6ed08SPL ID 2915e90c-21e3-44ba-97cf-a7ccf8f6ed08SPL set ID d9698809-4887-4514-aa28-0066355ef908RxCUI 855657UNII QTG126297Q

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

N450090417201 followed by a unit qualifier and the quantity

Package 50090-4172-01. 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 extended-release tablets and other treatment options before deciding to use diclofenac sodium extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals ( see WARNINGS , Gastrointestinal Bleeding, Ulceration, and Perforation ). Diclofenac Sodium Extended-release Tablets are indicated: for relief of the signs and symptoms of osteoarthritis for relief of the signs and symptoms of rheumatoid arthritis

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 075492

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

FDA NDC Directory listings under ANDA 075492
ProductStrengthForm · routeLabelerProduct NDC
Diclofenac Sodium ERdiclofenac sodiumDiclofenac sodium 100 mg/1Tablet, Film coated, Extended releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0210
Diclofenac SodiumDiclofenac sodium 100 mg/1Tablet, Film coated, Extended releaseOralProficient Rx LP63187-994
Diclofenac SodiumDiclofenac sodium 100 mg/1Tablet, Film coated, Extended releaseOralNuCare Pharmaceuticals,Inc.68071-2223
Diclofenac SodiumDiclofenac sodium 100 mg/1Tablet, Film coated, Extended releaseOralOceanside Pharmaceuticals68682-103
Diclofenac SodiumDiclofenac sodium 100 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack71335-0648

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