What is NDC 68083-313?

68083-313 is the product NDC for Bromfenac, Bromfenac sodium .9 mg/mL solution/ drops, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Gland Pharma Limited, NDC labeler code 68083. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Bromfenac?

7 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Bromfenac NDC 68083-313 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-313Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0313Add 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
68083-313-01	6808303130168083031301	1 BOTTLE, DROPPER in 1 CARTON (68083-313-01) / 1.7 mL in 1 BOTTLE, DROPPERMarketed from Mar 17, 2020

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): Bromfenac
Generic name (nonproprietary): bromfenac
Active ingredients: Bromfenac sodium — .9 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: Gland Pharma LimitedNDC labeler code 68083
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211029
Marketing start: Mar 17, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 68083-313_4aed36ae-5bc7-4be8-a511-a9126050e7deSPL ID 4aed36ae-5bc7-4be8-a511-a9126050e7deSPL set ID 2120380c-81e6-43ce-9211-aad1993b9be2RxCUI 578018UNII 8ECV571Y37
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. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N468083031301 followed by a unit qualifier and the quantity

Package 68083-0313-01. 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 Mar 27, 2020.

Indications (excerpt from the label)

Bromfenac ophthalmic solution 0.09% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. Bromfenac ophthalmic solution is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68083-313

What is NDC 68083-313?: 68083-313 is the product NDC for Bromfenac, Bromfenac sodium .9 mg/mL solution/ drops, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Bromfenac.
What is the active ingredient?: Bromfenac sodium.
Who is the labeler?: Gland Pharma Limited, NDC labeler code 68083. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Bromfenac?: 7 other product NDCs are listed under this name. See all Bromfenac 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 Bromfenac NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Bromfenac	Bromfenac sodium .7 mg/mL	Solution/ dropsOphthalmic	Amneal Pharmaceuticals NY LLC	60219-1526	60219-1526-03
Bromfenac	Bromfenac sodium .75 mg/mL	Solution/ dropsOphthalmic	Lupin Pharmaceuticals, Inc.	68180-434	68180-0434-01
Bromfenac	Bromfenac sodium .9 mg/mL	SolutionOphthalmic	Lupin Pharmaceuticals, Inc.	68180-436	68180-0436-01
Bromfenac	Bromfenac sodium 1.035 mg/mL	Solution/ dropsOphthalmic	ARMAS PHARMACEUTICALS INC.	72485-649	72485-0649-71
bromfenac	Bromfenac sodium 1.035 mg/mL	Solution/ dropsOphthalmic	Alembic Pharmaceuticals Limited	46708-508	46708-0508-17
Bromfenac	Bromfenac sodium .9 mg/mL	Solution/ dropsOphthalmic	Aurobindo Pharma Limited	65862-789	65862-0789-17
Bromfenac	Bromfenac sodium .9 mg/mL	Solution/ dropsOphthalmic	Fosun Pharma USA Inc.	72266-142	72266-0142-01

Other NDCs under ANDA 211029

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

FDA NDC Directory listings under ANDA 211029
Product	Strength	Form · route	Labeler	Product NDC
Bromfenac	Bromfenac sodium .9 mg/mL	Solution/ dropsOphthalmic	Fosun Pharma USA Inc.	72266-142