What is NDC 76420-598?

76420-598 is the product NDC for Diclofenac sodium, Diclofenac sodium 100 mg/1 tablet, film coated, listed with the FDA by Asclemed USA, Inc.. It has 7 package NDCs, shown above in 10- and 11-digit form.

Asclemed USA, Inc., NDC labeler code 76420. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Diclofenac sodium NDC 76420-598 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)76420-598Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76420-0598Add 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 NDC	11-digit (billing)	Package
76420-598-07	7642005980776420059807	7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-07)Marketed from Sep 2, 2023
76420-598-10	7642005981076420059810	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-10)Marketed from Sep 2, 2023
76420-598-14	7642005981476420059814	14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-14)Marketed from Sep 2, 2023
76420-598-20	7642005982076420059820	20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-20)Marketed from Sep 2, 2023
76420-598-30	7642005983076420059830	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-30)Marketed from Sep 2, 2023
76420-598-60	7642005986076420059860	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-60)Marketed from Sep 2, 2023
76420-598-90	7642005989076420059890	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-90)Marketed from Sep 2, 2023

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
Route: Oral
Labeler: Asclemed USA, Inc.NDC labeler code 76420
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216275
Marketing start: Sep 26, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
Identifiers: Product ID 76420-598_045ce619-2c60-e219-e063-6294a90a8cd5SPL ID 045ce619-2c60-e219-e063-6294a90a8cd5SPL set ID 6a9c3cea-7b46-427d-99af-90c1f290b190RxCUI 855657UNII QTG126297Q
Pharmacologic class: Nonsteroidal Anti-inflammatory Drug

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

N476420059807 followed by a unit qualifier and the quantity

Package 76420-0598-07. 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 Sep 2, 2023. 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 76420-598

What is NDC 76420-598?: 76420-598 is the product NDC for Diclofenac sodium, Diclofenac sodium 100 mg/1 tablet, film coated, listed with the FDA by Asclemed USA, Inc.. It has 7 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?: Asclemed USA, Inc., NDC labeler code 76420. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Diclofenac Sodiumdiclofenac sodium topical gel, 1%	Diclofenac sodium 10 mg/g	GelTopical	IPG Pharmaceuticals, inc.	71085-084	71085-0084-03
Diclofenac Sodium	Diclofenac sodium 10 mg/g	GelTopical	Target Corporation	11673-028	11673-0028-1011673-0028-15
Diclofenac Sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	Northwind Health Company, LLC	82868-114	82868-0114-30
Diclofenac Sodium	Diclofenac sodium 10 mg/g	GelTopical	Preferred Pharmaceuticals Inc.	68788-4135	68788-4135-01
Diclofenac Sodium	Diclofenac sodium 100 mg/1	Tablet, Film coated, Extended releaseOral	Aurobindo Pharma Limited	84386-103	84386-0103-01
Diclofenac Sodium	Diclofenac sodium 50 mg/1	Tablet, Delayed releaseOral	REMEDYREPACK INC.	70518-4694	70518-4694-00
Diclofenac sodium	Diclofenac sodium 30 mg/g	GelTopical	Preferred Pharmaceuticals Inc.	68788-4118	68788-4118-01
Diclofenac Sodium	Diclofenac sodium 10 mg/g	GelTopical	Preferred Pharmaceuticals Inc.	68788-4335	68788-4335-01
Diclofenac Sodium	Diclofenac sodium 25 mg/1	Tablet, Delayed releaseOral	Umedica Laboratories USA Inc.	60290-082	60290-0082-01
Diclofenac Sodium	Diclofenac sodium 50 mg/1	Tablet, Delayed releaseOral	Umedica Laboratories USA Inc.	60290-083	60290-0083-0160290-0083-0260290-0083-03+1 more

All 242 Diclofenac sodium NDCs

Other NDCs under ANDA 216275

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

FDA NDC Directory listings under ANDA 216275
Product	Strength	Form · route	Labeler	Product NDC
Diclofenac sodium	Diclofenac sodium 100 mg/1	Tablet, Film coatedOral	Ingenus Pharmaceuticals, LLC	50742-278
Diclofenac sodium	Diclofenac sodium 100 mg/1	Tablet, Film coatedOral	BluePoint Laboratories	68001-612
Diclofenac sodium	Diclofenac sodium 100 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4044
Diclofenac sodium	Diclofenac sodium 100 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-9665
Diclofenac sodium	Diclofenac sodium 100 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0414
Diclofenac sodium	Diclofenac sodium 100 mg/1	Tablet, Film coatedOral	Sportpharm LLC	85766-032