What is NDC 85534-0034?

85534-0034 is the product NDC for Diclofenac Epolamine, Diclofenac epolamine .013 g/1 system, listed with the FDA by HAWAII REPACK, INC.. It has 1 package NDC, shown above in 10- and 11-digit form.

HAWAII REPACK, INC., NDC labeler code 85534. 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 Epolamine?

10 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Diclofenac Epolamine NDC 85534-0034 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)85534-0034Labeler and product segments. Claims need a package NDC.

Product NDC at billing width85534-0034Add 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
85534-0034-0	85534003400	6 POUCH in 1 CARTON (85534-0034-0) / 5 SYSTEM in 1 POUCHMarketed from Jul 3, 2026

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 Epolamine
Generic name (nonproprietary): diclofenac epolamine
Active ingredients: Diclofenac epolamine — .013 g/1
Dosage form: System
Route: Topical
Labeler: HAWAII REPACK, INC.NDC labeler code 85534
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 021234
Marketing start: Nov 18, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
Identifiers: Product ID 85534-0034_55af5777-cc85-48d2-e063-6394a90a8ae1SPL ID 55af5777-cc85-48d2-e063-6394a90a8ae1SPL set ID 861907f7-a338-41c4-899e-48bd9a7e4749RxCUI 855626UNII X5F8EKL9ZG
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

N485534003400 followed by a unit qualifier and the quantity

Package 85534-0034-00. 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 Jul 3, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older. DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is a nonsteroidal anti-inflammatory drug (NSAID), and is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 85534-0034

What is NDC 85534-0034?: 85534-0034 is the product NDC for Diclofenac Epolamine, Diclofenac epolamine .013 g/1 system, listed with the FDA by HAWAII REPACK, INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Diclofenac Epolamine.
What is the active ingredient?: Diclofenac epolamine.
Who is the labeler?: HAWAII REPACK, INC., NDC labeler code 85534. 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 Epolamine?: 10 other product NDCs are listed under this name. See all Diclofenac Epolamine 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 Epolamine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Diclofenac Epolamine	Diclofenac epolamine .013 g/1	SystemTopical	Preferred Pharmaceuticals Inc.	68788-4115	68788-4115-03
Diclofenac Epolamine	Diclofenac epolamine .013 g/1	SystemTopical	Advanced Rx Pharmacy of Tennessee, LLC	80425-0403	80425-0403-01
diclofenac epolamine	Diclofenac epolamine .013 g/1	SystemTopical	Advanced Rx of Tennessee, LLC	80425-0364	80425-0364-01
diclofenac epolamine	Diclofenac epolamine .013 g/1	SystemTopical	Quality Care Products, LLC	83008-036	83008-0036-30
Diclofenac Epolamine	Diclofenac epolamine .013 g/1	SystemTopical	Asclemed USA, Inc.	76420-673	76420-0673-30
Diclofenac Epolamine	Diclofenac epolamine .013 g/1	SystemTopical	YARAL Pharma Inc.	82347-0405	82347-0405-0582347-0405-06
Diclofenac Epolamine	Diclofenac epolamine .013 g/1	SystemTopical	Phoenix RX LLC	85509-1405	85509-1405-03
Diclofenac Epolamine	Diclofenac epolamine .013 g/1	SystemTopical	Sportpharm LLC	85766-265	85766-0265-1585766-0265-30
diclofenac epolamine	Diclofenac epolamine .013 g/1	SystemTopical	Teva Pharmaceuticals USA Inc.	0093-3727	00093-3727-55
diclofenac epolamine	Diclofenac epolamine .013 g/1	SystemTopical	ASCLEMED USA INC.	76420-409	76420-0409-30

Other NDCs under NDA 021234

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

FDA NDC Directory listings under NDA 021234
Product	Strength	Form · route	Labeler	Product NDC
diclofenac epolamine	Diclofenac epolamine .013 g/1	SystemTopical	Teva Pharmaceuticals USA Inc.	0093-3727
Diclofenac Epolamine	Diclofenac epolamine .013 g/1	SystemTopical	Preferred Pharmaceuticals Inc.	68788-4115
diclofenac epolamine	Diclofenac epolamine .013 g/1	SystemTopical	ASCLEMED USA INC.	76420-409
Diclofenac Epolamine	Diclofenac epolamine .013 g/1	SystemTopical	Asclemed USA, Inc.	76420-673
diclofenac epolamine	Diclofenac epolamine .013 g/1	SystemTopical	Advanced Rx of Tennessee, LLC	80425-0364
Diclofenac Epolamine	Diclofenac epolamine .013 g/1	SystemTopical	Advanced Rx Pharmacy of Tennessee, LLC	80425-0403
Diclofenac Epolamine	Diclofenac epolamine .013 g/1	SystemTopical	YARAL Pharma Inc.	82347-0405
diclofenac epolamine	Diclofenac epolamine .013 g/1	SystemTopical	Quality Care Products, LLC	83008-036
Diclofenac Epolamine	Diclofenac epolamine .013 g/1	SystemTopical	Phoenix RX LLC	85509-1405
Diclofenac Epolamine	Diclofenac epolamine .013 g/1	SystemTopical	Sportpharm LLC	85766-265
Diclox Patch 30CTdiclofenac epolamine 1.3% patch	Diclofenac epolamine .013 g/1	SystemTopical	Injecta Medcial LLC	87234-0405
Flectordiclofenac epolamine	Diclofenac epolamine .013 g/1	SystemTopical	IBSA Pharma Inc.	71858-0405