Diclofenac Sodium NDC 0472-1783

NDC codes

FDA NDC Directory

Product NDC (as listed)0472-1783Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00472-1783Add 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
0472-1783-10	00472178310	1 TUBE in 1 CARTON (0472-1783-10) / 100 g in 1 TUBEMarketed from May 19, 2016

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 30 mg/g
Dosage form: Gel
Route: Topical
Labeler: Actavis Pharma, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206493
Marketing start: May 19, 2016
Marketing end: Feb 28, 2027
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
Identifiers: Product ID 0472-1783_6b4784a2-31ca-485a-9bff-6c322c0cb902SPL ID 6b4784a2-31ca-485a-9bff-6c322c0cb902SPL set ID 74169b2d-ac56-4757-86c4-cdcfcd5f4eb5RxCUI 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

N400472178310 followed by a unit qualifier and the quantity

Package 00472-1783-10. 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 Jan 30, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Diclofenac sodium topical gel is indicated for the topical treatment of actinic keratosis (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 206493

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

FDA NDC Directory listings under ANDA 206493
Product	Strength	Form · route	Labeler	Product NDC
Diclofenac Sodium	Diclofenac sodium 30 mg/g	GelTopical	Proficient Rx LP	71205-752
Diclofenac Sodium	Diclofenac sodium 30 mg/g	GelTopical	Asclemed USA, Inc.	76420-261