NDC codes

FDA NDC Directory
Product NDC (as listed)71205-991Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71205-0991Add 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
71205-991-0071205099100100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-00)Marketed from Apr 1, 2020
71205-991-11712050991111000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-11)Marketed from Apr 1, 2020
71205-991-307120509913030 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-30)Marketed from Apr 1, 2020
71205-991-5571205099155500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-55)Marketed from Apr 1, 2020
71205-991-607120509916060 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-60)Marketed from Apr 1, 2020
71205-991-7271205099172120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-72)Marketed from Apr 1, 2020
71205-991-7871205099178180 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-78)Marketed from Apr 1, 2020
71205-991-907120509919090 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-90)Marketed from Apr 1, 2020

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
Labeler
Proficient Rx LPNDC labeler code 71205
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 71205-991_38aee69e-e66f-42b1-814a-551742b1a9cdSPL ID 38aee69e-e66f-42b1-814a-551742b1a9cdSPL set ID afce2de2-0c59-4191-bf79-782ca31e427dRxCUI 855906, 855926UNII QTG126297QUPC 0371205995300, 0371205991302

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

N471205099100 followed by a unit qualifier and the quantity

Package 71205-0991-00. 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)

About NDC 71205-991

What is NDC 71205-991?
71205-991 is the product NDC for Diclofenac Sodium Delayed Release, Diclofenac sodium 75 mg/1 tablet, delayed release, listed with the FDA by Proficient Rx LP. It has 8 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?
Proficient Rx LP, NDC labeler code 71205. 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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