Buprenorphine and Naloxone NDC 43598-580

NDC codes

FDA NDC Directory

Product NDC (as listed)43598-580Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43598-0580Add 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
43598-580-30	43598058030	30 POUCH in 1 CARTON (43598-580-30) / 1 FILM, SOLUBLE in 1 POUCH (43598-580-01)Marketed from Jun 14, 2018

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): Buprenorphine and Naloxone
Generic name (nonproprietary): buprenorphine and naloxone
Active ingredients: Buprenorphine hydrochloride — 4 mg/1Naloxone — 1 mg/1
Dosage form: Film, Soluble
Route: Buccal, Sublingual
Labeler: Dr.Reddys Laboratories Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205806
Marketing start: Jun 14, 2018
Listing expires: Dec 31, 2027
DEA schedule: CIII
Other FDA classes: Opioid Antagonists (Mechanism)Partial Opioid Agonists (Mechanism)
Identifiers: Product ID 43598-580_af3c8314-5a38-2103-6ef8-94f179ffd541SPL ID af3c8314-5a38-2103-6ef8-94f179ffd541SPL set ID 72dc1ec0-7c59-a587-4ffd-c40ef79e6fb2RxCUI 1307056, 1307061UNII 56W8MW3EN1, 36B82AMQ7NUPC 0343598580012
Pharmacologic class: Opioid Antagonist; Partial Opioid Agonist

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. Buccal, Sublingual products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N443598058030 followed by a unit qualifier and the quantity

Package 43598-0580-30. 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

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