NDC codes

FDA NDC Directory
Product NDC (as listed)71335-0648Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-0648Add 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
71335-0648-1713350648017133506480160 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0648-1)Marketed from May 22, 2018
71335-0648-2713350648027133506480230 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0648-2)Marketed from Apr 13, 2018
71335-0648-3713350648037133506480315 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0648-3)Marketed from Jan 29, 2025
71335-0648-4713350648047133506480414 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0648-4)Marketed from Jul 23, 2018
71335-0648-5713350648057133506480510 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0648-5)Marketed from Oct 13, 2022
71335-0648-6713350648067133506480621 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0648-6)Marketed from Jul 3, 2018
71335-0648-7713350648077133506480790 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0648-7)Marketed from Apr 16, 2019
71335-0648-87133506480871335064808120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0648-8)Marketed from Jan 29, 2025
71335-0648-971335064809713350648097 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0648-9)Marketed from Jan 29, 2025

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
Labeler
Bryant Ranch PrepackNDC labeler code 71335
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 71335-0648_cfa0cb80-a307-440c-99c4-88576c0c8bdbSPL ID cfa0cb80-a307-440c-99c4-88576c0c8bdbSPL set ID 49013aad-475c-4efb-84c6-15a5d4664fbfRxCUI 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

N471335064801 followed by a unit qualifier and the quantity

Package 71335-0648-01. 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 71335-0648

What is NDC 71335-0648?
71335-0648 is the product NDC for Diclofenac Sodium, Diclofenac sodium 100 mg/1 tablet, film coated, extended release, listed with the FDA by Bryant Ranch Prepack. It has 9 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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 releaseOralOceanside Pharmaceuticals68682-103
Diclofenac Sodium ERdiclofenac sodiumDiclofenac sodium 100 mg/1Tablet, Film coated, Extended releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0210

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