Diclofenac sodium NDC 68071-3688

NDC codes

FDA NDC Directory

Product NDC (as listed)68071-3688Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68071-3688Add 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
68071-3688-1	68071368801	1 TUBE in 1 CARTON (68071-3688-1) / 100 g in 1 TUBEMarketed from Sep 25, 2024

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 — 30 mg/g
Dosage form: Gel
Route: Topical
Labeler: NuCare Pharmaceuticals,Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206298
Marketing start: Apr 28, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
Identifiers: Product ID 68071-3688_22f4d76c-590b-5c7d-e063-6394a90ae82dSPL ID 22f4d76c-590b-5c7d-e063-6394a90ae82dSPL set ID 22f4b8aa-902f-a860-e063-6394a90ada26RxCUI 855642UNII QTG126297QUPC 0368071368819
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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N468071368801 followed by a unit qualifier and the quantity

Package 68071-3688-01. 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 Sep 25, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Diclofenac sodium topical gel is indicated for the topical treatment of actinic keratoses (AK). Diclofenac sodium topical gel is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the topical treatment of actinic keratoses (AK). ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 206298

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

FDA NDC Directory listings under ANDA 206298
Product	Strength	Form · route	Labeler	Product NDC
Diclofenac Sodium	Diclofenac sodium 30 mg/g	GelTopical	Direct_Rx	72189-040
Diclofenac sodium	Diclofenac sodium 30 mg/g	GelTopical	Proficient Rx LP	71205-538
Diclofenac sodium	Diclofenac sodium 30 mg/g	GelTopical	Sun Pharmaceutical Industries, Inc.	51672-1363
Diclofenac sodium	Diclofenac sodium 30 mg/g	GelTopical	Asclemed USA, Inc.	76420-275
Diclofenac Sodium	Diclofenac sodium 30 mg/g	GelTopical	Advanced Rx Pharmacy of Tennessee, LLC	80425-0235
Diclofenac sodium	Diclofenac sodium 30 mg/g	GelTopical	Preferred Pharmaceuticals Inc.	68788-8236
Diclofenac sodium	Diclofenac sodium 30 mg/g	GelTopical	Preferred Pharmaceuticals Inc.	68788-4118