What is NDC 43598-588?

43598-588 is the product NDC for Difluprednate Ophthalmic Emulsion, Difluprednate .5 mg/mL emulsion, listed with the FDA by Dr. Reddy's Laboratories Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Difluprednate Ophthalmic Emulsion (Difluprednate Ophthalmic).

Dr. Reddy's Laboratories Inc., NDC labeler code 43598. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Difluprednate Ophthalmic Emulsion?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Difluprednate Ophthalmic Emulsion NDC 43598-588

NDC codes

FDA NDC Directory

Product NDC (as listed)43598-588Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43598-0588Add 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
43598-588-11	4359805881143598058811	1 BOTTLE in 1 CARTON (43598-588-11) / 5 mL in 1 BOTTLEMarketed from Dec 25, 2022

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): Difluprednate Ophthalmic Emulsion
Generic name (nonproprietary): difluprednate ophthalmic
Active ingredients: Difluprednate — .5 mg/mL
Dosage form: Emulsion
Route: Ophthalmic
Labeler: Dr. Reddy's Laboratories Inc.NDC labeler code 43598
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214894
Marketing start: Dec 25, 2022
Listing expires: Dec 31, 2027
Identifiers: Product ID 43598-588_acd98bc6-dcd8-d0f5-9b9a-d2652e0c37c6SPL ID acd98bc6-dcd8-d0f5-9b9a-d2652e0c37c6SPL set ID 12803630-3196-1b3e-28e4-a598a742ef1aRxCUI 804544UNII S8A06QG2QE

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. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N443598058811 followed by a unit qualifier and the quantity

Package 43598-0588-11. 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 24, 2025.

Indications (excerpt from the label)

Difluprednate ophthalmic emulsion (0.05%) is a corticosteroid indicated for: The treatment of inflammation and pain associated with ocular surgery ( 1.1 ) The treatment of endogenous anterior uveitis ( 1.2 ) 1.1 Ocular Surgery Difluprednate ophthalmic emulsion (0.05%) is indicated for the treatment of inflammation and pain associated with ocular surgery. 1.2 Endogenous Anterior Uveitis Difluprednate ophthalmic emulsion (0.05%) is indicated for the treatment of endogenous anterior uveitis.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43598-588

What is NDC 43598-588?: 43598-588 is the product NDC for Difluprednate Ophthalmic Emulsion, Difluprednate .5 mg/mL emulsion, listed with the FDA by Dr. Reddy's Laboratories Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Difluprednate Ophthalmic Emulsion (Difluprednate Ophthalmic).
What is the active ingredient?: Difluprednate.
Who is the labeler?: Dr. Reddy's Laboratories Inc., NDC labeler code 43598. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Difluprednate Ophthalmic Emulsion?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Difluprednate Ophthalmic Emulsion (Difluprednate ophthalmic) NDC 43598-588