NDC codes

FDA NDC Directory
Product NDC (as listed)68788-8193Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-8193Add 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
68788-8193-16878881930168788819301100 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8193-1)Marketed from May 16, 2022
68788-8193-3687888193036878881930330 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8193-3)Marketed from May 16, 2022
68788-8193-6687888193066878881930660 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8193-6)Marketed from May 16, 2022
68788-8193-86878881930868788819308120 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8193-8)Marketed from May 16, 2022
68788-8193-9687888193096878881930990 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8193-9)Marketed from May 16, 2022

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 — 75 mg/1
Dosage form
Tablet, Delayed release
Route
Oral
Labeler
Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077863
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
Identifiers
Product ID 68788-8193_403085a5-446c-4796-aaf1-64be07a98c9aSPL ID 403085a5-446c-4796-aaf1-64be07a98c9aSPL set ID ed1b5ec7-2812-4a81-90d1-953baa0b0ec8RxCUI 855926UNII 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

N468788819301 followed by a unit qualifier and the quantity

Package 68788-8193-01. 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 sodium delayed-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 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)

About NDC 68788-8193

What is NDC 68788-8193?
68788-8193 is the product NDC for Diclofenac Sodium, Diclofenac sodium 75 mg/1 tablet, delayed release, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 5 package NDCs, 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?
Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 077863

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

FDA NDC Directory listings under ANDA 077863
ProductStrengthForm · routeLabelerProduct NDC
Diclofenac DRdiclofenacDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralAdvanced Rx of Tennessee, LLC80425-0056
Diclofenac SodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralRising Pharma Holdings, Inc.16571-201
Diclofenac SodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralA-S Medication Solutions50090-6924
Diclofenac SodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralAmerican Health Packaging60687-658
Diclofenac SodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralSt. Mary's Medical Park Pharmacy60760-090
Diclofenac SodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralProficient Rx LP63187-012
Diclofenac SodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralNuCare Pharmaceuticals,Inc.66267-071
Diclofenac SodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralCoupler LLC67046-1482
Diclofenac SodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralBluePoint Laboratories68001-281
Diclofenac SodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralBryant Ranch Prepack71335-0456
Diclofenac SodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralPD-Rx Pharmaceuticals, Inc.72789-578
Diclofenac SodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralAsclemed USA, Inc.76420-670
Diclofenac SodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralPHOENIX RX LLC85509-1201
Diclofenac SodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralSportpharm LLC85766-010

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