What is NDC 46708-583?

46708-583 is the product NDC for Bromfenac Sodium, Bromfenac sodium .805 mg/mL solution/ drops, listed with the FDA by Alembic Pharmaceuticals Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 Sodium?

2 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Bromfenac Sodium NDC 46708-583 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-583Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0583Add 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
46708-583-03	4670805830346708058303	1 BOTTLE in 1 CARTON (46708-583-03) / 3 mL in 1 BOTTLEMarketed from Jul 8, 2024

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 Sodium
Generic name (nonproprietary): bromfenac sodium
Active ingredients: Bromfenac sodium — .805 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: Alembic Pharmaceuticals LimitedNDC labeler code 46708
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214340
Marketing start: Jul 8, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 46708-583_f66f1436-daaa-412a-8822-c64866cfeadaSPL ID f66f1436-daaa-412a-8822-c64866cfeadaSPL set ID f66f1436-daaa-412a-8822-c64866cfeadaRxCUI 1375917UNII 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

N446708058303 followed by a unit qualifier and the quantity

Package 46708-0583-03. 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 9, 2024.

Indications (excerpt from the label)

Bromfenac ophthalmic solution 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. BROMFENAC 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 surgery. (1) .

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 46708-583

What is NDC 46708-583?: 46708-583 is the product NDC for Bromfenac Sodium, Bromfenac sodium .805 mg/mL solution/ drops, listed with the FDA by Alembic Pharmaceuticals Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Bromfenac Sodium.
What is the active ingredient?: Bromfenac sodium.
Who is the labeler?: Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 Sodium?: 2 other product NDCs are listed under this name. See all Bromfenac Sodium 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 Sodium NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Bromfenac Sodium	Bromfenac sodium .805 mg/mL	Solution/ dropsOphthalmic	Alembic Pharmaceuticals Inc.	62332-583	62332-0583-03
bromfenac sodium	Bromfenac sodium .805 mg/mL	Solution/ dropsOphthalmic	Lupin Pharmaceuticals, Inc.	68180-433	68180-0433-02

Other NDCs under ANDA 214340

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

FDA NDC Directory listings under ANDA 214340
Product	Strength	Form · route	Labeler	Product NDC
Bromfenac Sodium	Bromfenac sodium .805 mg/mL	Solution/ dropsOphthalmic	Alembic Pharmaceuticals Inc.	62332-583