What is NDC 68001-281?

68001-281 is the product NDC for Diclofenac Sodium, Diclofenac sodium 75 mg/1 tablet, delayed release, listed with the FDA by BluePoint Laboratories. It has 4 package NDCs, shown above in 10- and 11-digit form.

BluePoint Laboratories, NDC labeler code 68001. 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 68001-281 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68001-281Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68001-0281Add 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
68001-281-00	6800102810068001028100	100 TABLET, DELAYED RELEASE in 1 BOTTLE (68001-281-00)Marketed from Dec 21, 2015
68001-281-03	6800102810368001028103	500 TABLET, DELAYED RELEASE in 1 BOTTLE (68001-281-03)Marketed from Dec 21, 2015
68001-281-06	6800102810668001028106	60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68001-281-06)Marketed from Dec 21, 2015
68001-281-08	6800102810868001028108	1000 TABLET, DELAYED RELEASE in 1 BOTTLE (68001-281-08)Marketed from Dec 21, 2015

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 — 75 mg/1
Dosage form: Tablet, Delayed release
Route: Oral
Labeler: BluePoint LaboratoriesNDC labeler code 68001
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077863
Marketing start: Dec 21, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
Identifiers: Product ID 68001-281_411b49de-cfcc-2b9f-e063-6394a90a06b7SPL ID 411b49de-cfcc-2b9f-e063-6394a90a06b7SPL set ID feb1541a-de83-47dd-be03-c43376527318RxCUI 855664, 855906, 855926UNII QTG126297QUPC 0368001280006, 0368001281003
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

N468001028100 followed by a unit qualifier and the quantity

Package 68001-0281-00. 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 Oct 14, 2025. 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 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 68001-281

What is NDC 68001-281?: 68001-281 is the product NDC for Diclofenac Sodium, Diclofenac sodium 75 mg/1 tablet, delayed release, listed with the FDA by BluePoint Laboratories. It has 4 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?: BluePoint Laboratories, NDC labeler code 68001. 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 077863

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

FDA NDC Directory listings under ANDA 077863
Product	Strength	Form · route	Labeler	Product NDC
Diclofenac DRdiclofenac	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	Advanced Rx of Tennessee, LLC	80425-0056
Diclofenac Sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	Rising Pharma Holdings, Inc.	16571-201
Diclofenac Sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	A-S Medication Solutions	50090-6924
Diclofenac Sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	American Health Packaging	60687-658
Diclofenac Sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	St. Mary's Medical Park Pharmacy	60760-090
Diclofenac Sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	Proficient Rx LP	63187-012
Diclofenac Sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	NuCare Pharmaceuticals,Inc.	66267-071
Diclofenac Sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	Coupler LLC	67046-1482
Diclofenac Sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	Preferred Pharmaceuticals Inc.	68788-8193
Diclofenac Sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	Bryant Ranch Prepack	71335-0456
Diclofenac Sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	PD-Rx Pharmaceuticals, Inc.	72789-578
Diclofenac Sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	Asclemed USA, Inc.	76420-670
Diclofenac Sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	PHOENIX RX LLC	85509-1201
Diclofenac Sodium	Diclofenac sodium 75 mg/1	Tablet, Delayed releaseOral	Sportpharm LLC	85766-010