NDC codes

FDA NDC Directory
Product NDC (as listed)68682-103Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68682-0103Add 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
68682-103-016868201030168682010301100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68682-103-01)Marketed from Feb 28, 2000

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 — 100 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Labeler
Oceanside PharmaceuticalsNDC labeler code 68682
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 68682-103_303dda9b-8a02-68c8-e063-6294a90a2d5eSPL ID 303dda9b-8a02-68c8-e063-6294a90a2d5eSPL set ID c48113e0-9f1e-4086-b18f-3204c0d2a689RxCUI 855657UNII QTG126297QUPC 0368682103014

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

N468682010301 followed by a unit qualifier and the quantity

Package 68682-0103-01. 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)

About NDC 68682-103

What is NDC 68682-103?
68682-103 is the product NDC for Diclofenac Sodium, Diclofenac sodium 100 mg/1 tablet, film coated, extended release, listed with the FDA by Oceanside Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Diclofenac Sodium.
What is the active ingredient?
Diclofenac sodium.
Who is the labeler?
Oceanside Pharmaceuticals, NDC labeler code 68682. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Diclofenac Sodium?
241 other product NDCs are listed under this name. See all Diclofenac Sodium NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Diclofenac Sodium NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Diclofenac Sodiumdiclofenac sodium topical gel, 1%Diclofenac sodium 10 mg/gGelTopicalIPG Pharmaceuticals, inc.71085-08471085-0084-03
Diclofenac SodiumDiclofenac sodium 10 mg/gGelTopicalTarget Corporation11673-02811673-0028-1011673-0028-15
Diclofenac SodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralNorthwind Health Company, LLC82868-11482868-0114-30
Diclofenac SodiumDiclofenac sodium 10 mg/gGelTopicalPreferred Pharmaceuticals Inc.68788-413568788-4135-01
Diclofenac SodiumDiclofenac sodium 100 mg/1Tablet, Film coated, Extended releaseOralAurobindo Pharma Limited84386-10384386-0103-01
Diclofenac SodiumDiclofenac sodium 50 mg/1Tablet, Delayed releaseOralREMEDYREPACK INC.70518-469470518-4694-00
Diclofenac sodiumDiclofenac sodium 30 mg/gGelTopicalPreferred Pharmaceuticals Inc.68788-411868788-4118-01
Diclofenac SodiumDiclofenac sodium 10 mg/gGelTopicalPreferred Pharmaceuticals Inc.68788-433568788-4335-01
Diclofenac SodiumDiclofenac sodium 25 mg/1Tablet, Delayed releaseOralUmedica Laboratories USA Inc.60290-08260290-0082-01
Diclofenac SodiumDiclofenac sodium 50 mg/1Tablet, Delayed releaseOralUmedica Laboratories USA Inc.60290-08360290-0083-0160290-0083-0260290-0083-03+1 more

All 242 Diclofenac Sodium NDCs

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 SodiumDiclofenac sodium 100 mg/1Tablet, Film coated, Extended releaseOralA-S Medication Solutions50090-4172
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 releaseOralBryant Ranch Prepack71335-0648
Diclofenac Sodium ERdiclofenac sodiumDiclofenac sodium 100 mg/1Tablet, Film coated, Extended releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0210

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