Diclofenac Sodium NDC 68788-9435

NDC codes

FDA NDC Directory

Product NDC (as listed)68788-9435Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68788-9435Add 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
68788-9435-1	68788943501	1 TUBE in 1 CARTON (68788-9435-1) / 100 g in 1 TUBEMarketed from Jun 8, 2018

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: Preferred Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208301
Marketing start: Jun 8, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
Identifiers: Product ID 68788-9435_5ea4eca4-6eac-4227-bc73-2df44d81218cSPL ID 5ea4eca4-6eac-4227-bc73-2df44d81218cSPL set ID 5d0a4b41-afbf-45e7-bb1c-587d72314ee0RxCUI 855642UNII 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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N468788943501 followed by a unit qualifier and the quantity

Package 68788-9435-01. 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 Apr 2, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 208301

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

FDA NDC Directory listings under ANDA 208301
Product	Strength	Form · route	Labeler	Product NDC
Diclofenac Sodium Gel	Diclofenac sodium 30 mg/g	GelTopical	Direct_Rx	72189-379
Diclofenac Sodium	Diclofenac sodium 30 mg/g	GelTopical	Advanced Rx Pharmacy of Tennessee, LLC	80425-0236
Diclofenac Sodium	Diclofenac sodium 30 mg/g	GelTopical	HAWAII REPACK, INC	85534-0089
Diclofenac Sodium	Diclofenac sodium 30 mg/g	GelTopical	REMEDYREPACK INC.	70518-3315
Diclofenac Sodium	Diclofenac sodium 30 mg/g	GelTopical	Proficient Rx LP	82804-052
Diclofenac Sodium	Diclofenac sodium 30 mg/g	GelTopical	NuCare Pharmaceuticals,Inc.	68071-3516
Diclofenac Sodium	Diclofenac sodium 30 mg/g	GelTopical	GLENMARK PHARMACEUTICALS INC., USA	68462-355
Diclofenac Sodium	Diclofenac sodium 30 mg/g	GelTopical	Asclemed USA, Inc.	76420-132