What is NDC 71610-068?

71610-068 is the product NDC for Diclofenac Sodium, Diclofenac sodium 50 mg/1 tablet, delayed release, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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 71610-068 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-068Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0068Add 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	Copy
71610-068-80	7161000688071610006880	180 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-068-80)Marketed from May 14, 2018

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 — 50 mg/1
Dosage form: Tablet, Delayed release
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 074514
Marketing start: Jul 27, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
Identifiers: Product ID 71610-068_dc9b6499-7a34-4757-86b2-0880f3288048SPL ID dc9b6499-7a34-4757-86b2-0880f3288048SPL set ID e4af374a-1281-46af-a0a9-48820db6c947RxCUI 855906UNII 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

N471610006880 followed by a unit qualifier and the quantity

Package 71610-0068-80. 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 May 31, 2018. 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, USP 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 71610-068

What is NDC 71610-068?: 71610-068 is the product NDC for Diclofenac Sodium, Diclofenac sodium 50 mg/1 tablet, delayed release, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, 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?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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 074514

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

FDA NDC Directory listings under ANDA 074514
Product	Strength	Form · route	Labeler	Product NDC
Diclofenac Sodium	Diclofenac sodium 50 mg/1	Tablet, Delayed releaseOral	Actavis Pharma, Inc.	0228-2550
Diclofenac Sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	Actavis Pharma, Inc.	0228-2551
Diclofenac Sodium	Diclofenac sodium 50 mg/1	Tablet, Delayed releaseOral	PD-Rx Pharmaceuticals, Inc.	43063-467
Diclofenac Sodium	Diclofenac sodium 50 mg/1	Tablet, Delayed releaseOral	A-S Medication Solutions	50090-0538
Diclofenac Sodium	Diclofenac sodium 50 mg/1	Tablet, Delayed releaseOral	A-S Medication Solutions	50090-0539
Diclofenac Sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	PD-Rx Pharmaceuticals, Inc.	55289-150
Diclofenac Sodium	Diclofenac sodium 50 mg/1	Tablet, Delayed releaseOral	Golden State Medical Supply, Inc.	60429-421
Diclofenac Sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	Golden State Medical Supply, Inc.	60429-422
Diclofenac Sodium	Diclofenac sodium 50 mg/1	Tablet, Delayed releaseOral	Proficient Rx LP	63187-522
Diclofenac Sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	Proficient Rx LP	63187-761