NDC codes

FDA NDC Directory
Product NDC (as listed)68788-9806Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-9806Add 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
68788-9806-168788980601100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68788-9806-1)Marketed from Aug 31, 2015
68788-9806-26878898060220 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68788-9806-2)Marketed from Aug 31, 2015
68788-9806-36878898060330 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68788-9806-3)Marketed from Aug 31, 2015
68788-9806-66878898060660 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68788-9806-6)Marketed from Aug 31, 2015
68788-9806-868788980608120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68788-9806-8)Marketed from Aug 31, 2015
68788-9806-96878898060990 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68788-9806-9)Marketed from Aug 31, 2015

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 Delayed ReleaseSuffix: Delayed Release
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 075185
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
Identifiers
Product ID 68788-9806_9f3a2f24-29c2-411a-b19c-597f198b3cbfSPL ID 9f3a2f24-29c2-411a-b19c-597f198b3cbfSPL set ID c933eaad-ba53-4130-90db-a66f89dfc29fRxCUI 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

N468788980601 followed by a unit qualifier and the quantity

Package 68788-9806-01. 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 ). 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)

About NDC 68788-9806

What is NDC 68788-9806?
68788-9806 is the product NDC for Diclofenac Sodium Delayed Release, Diclofenac sodium 75 mg/1 tablet, delayed release, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 6 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Diclofenac Sodium Delayed Release (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 Delayed Release?
47 other product NDCs are listed under this name. See all Diclofenac Sodium Delayed Release 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 Delayed Release NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Diclofenac Sodium Delayed Releasediclofenac sodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralPreferred Pharmaceuticals Inc.68788-419468788-4194-0168788-4194-0368788-4194-06+2 more
Diclofenac Sodium Delayed Releasediclofenac sodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralREMEDYREPACK INC.70518-460270518-4602-00
Diclofenac Sodium Delayed Releasediclofenac sodiumDiclofenac sodium 50 mg/1Tablet, Delayed releaseOralAdvanced Rx of Tennessee, LLC80425-056980425-0569-0180425-0569-02
Diclofenac Sodium Delayed Releasediclofenac sodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralA-S Medication Solutions50090-783850090-7838-0050090-7838-0150090-7838-02+4 more
Diclofenac Sodium Delayed Releasediclofenac sodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralA-S Medication Solutions50090-783950090-7839-00
Diclofenac Sodium Delayed Releasediclofenac sodiumDiclofenac sodium 50 mg/1Tablet, Delayed releaseOralA-S Medication Solutions50090-788050090-7880-01
Diclofenac Sodium Delayed Releasediclofenac sodiumDiclofenac sodium 50 mg/1Tablet, Delayed releaseOralA-S Medication Solutions50090-788150090-7881-0050090-7881-0250090-7881-05
Diclofenac Sodium Delayed Releasediclofenac sodiumDiclofenac sodium 50 mg/1Tablet, Delayed releaseOralCarlsbad Technology, Inc.61442-22661442-0226-0161442-0226-1061442-0226-60
Diclofenac Sodium Delayed Releasediclofenac sodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralCarlsbad Technology, Inc.61442-22761442-0227-0161442-0227-0561442-0227-10+1 more
Diclofenac Sodium Delayed Releasediclofenac sodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralRedpharm Drug67296-221567296-2215-0167296-2215-02

All 48 Diclofenac Sodium Delayed Release NDCs

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 SodiumDiclofenac sodium 50 mg/1Tablet, Delayed releaseOralAvKARE42291-230
Diclofenac SodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralAvKARE42291-231
Diclofenac SodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralRedPharm Drug, Inc.67296-1197
Diclofenac SodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralSOLA Pharmaceuticals, LLC70512-784
Diclofenac SodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralAdvanced Rx of Tennessee, LLC80425-0564
Diclofenac Sodium D/RDiclofenac sodium 50 mg/1Tablet, Delayed releaseOralDirectRx72189-675
Diclofenac Sodium Delayed Releasediclofenac sodiumDiclofenac sodium 50 mg/1Tablet, Delayed releaseOralA-S Medication Solutions50090-0542
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 releaseOralA-S Medication Solutions50090-7818
Diclofenac Sodium Delayed Releasediclofenac sodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralA-S Medication Solutions50090-7838
Diclofenac Sodium Delayed Releasediclofenac sodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralA-S Medication Solutions50090-7839
Diclofenac Sodium Delayed Releasediclofenac sodiumDiclofenac sodium 50 mg/1Tablet, Delayed releaseOralA-S Medication Solutions50090-7880
Diclofenac Sodium Delayed Releasediclofenac sodiumDiclofenac sodium 50 mg/1Tablet, Delayed releaseOralA-S Medication Solutions50090-7881
Diclofenac Sodium Delayed Releasediclofenac sodiumDiclofenac sodium 25 mg/1Tablet, Delayed releaseOralGolden State Medical Supply, Inc.51407-536
Diclofenac Sodium Delayed Releasediclofenac sodiumDiclofenac sodium 50 mg/1Tablet, Delayed releaseOralGolden State Medical Supply, Inc.51407-537
Diclofenac Sodium Delayed Releasediclofenac sodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralGolden State Medical Supply, Inc.51407-538
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 Delayed Releasediclofenac sodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralNorthwind Health Company, LLC51655-176

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