What is NDC 43598-580?

43598-580 is the product NDC for Buprenorphine and Naloxone, Buprenorphine hydrochloride 4 mg/1; Naloxone 1 mg/1 film, soluble, listed with the FDA by Dr.Reddys Laboratories Inc. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Buprenorphine hydrochloride, Naloxone.

Dr.Reddys 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 Buprenorphine and Naloxone?

50 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

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	4359805803043598058030	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 IncNDC labeler code 43598
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 36B82AMQ7N, 56W8MW3EN1UPC 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

Current FDA label (SPL), effective Jan 12, 2026.

Indications (excerpt from the label)

Buprenorphine and naloxone sublingual film is indicated for treatment of opioid dependence. Buprenorphine and naloxone sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support. Buprenorphine and naloxone sublingual film contains buprenorphine, a partial-opioid agonist and naloxone, an opioid antagonist, and is indicated for treatment of opioid dependence. ( 1 ) Buprenorphine and naloxone sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43598-580

What is NDC 43598-580?: 43598-580 is the product NDC for Buprenorphine and Naloxone, Buprenorphine hydrochloride 4 mg/1; Naloxone 1 mg/1 film, soluble, listed with the FDA by Dr.Reddys Laboratories Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Buprenorphine and Naloxone.
What is the active ingredient?: Buprenorphine hydrochloride, Naloxone.
Who is the labeler?: Dr.Reddys 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 Buprenorphine and Naloxone?: 50 other product NDCs are listed under this name. See all Buprenorphine and Naloxone 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 Buprenorphine and Naloxone NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Buprenorphine And Naloxone	Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride 2 mg/1	TabletSublingual	Ascend Laboratories, LLC	67877-606	67877-0606-3067877-0606-8467877-0606-90
Buprenorphine And Naloxone	Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride .5 mg/1	TabletSublingual	Ascend Laboratories, LLC	67877-607	67877-0607-3067877-0607-8467877-0607-90
Buprenorphine and Naloxone	Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride .5 mg/1	Film, SolubleBuccal, Sublingual	Camber Pharmaceuticals, Inc.	31722-479	31722-0479-30
Buprenorphine and Naloxone	Buprenorphine hydrochloride 4 mg/1; Naloxone hydrochloride 1 mg/1	Film, SolubleBuccal, Sublingual	Camber Pharmaceuticals, Inc.	31722-480	31722-0480-30
Buprenorphine and Naloxone	Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride 2 mg/1	Film, SolubleBuccal, Sublingual	Camber Pharmaceuticals, Inc.	31722-481	31722-0481-30
Buprenorphine and Naloxone	Buprenorphine hydrochloride 12 mg/1; Naloxone hydrochloride 3 mg/1	Film, SolubleBuccal, Sublingual	Camber Pharmaceuticals, Inc.	31722-482	31722-0482-30
Buprenorphine and Naloxone	Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1	TabletSublingual	Unit Dose Solutions, Inc.	87441-001	87441-0001-01
Buprenorphine and Naloxone	Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1	TabletSublingual	Camber Pharmaceuticals, Inc.	31722-850	31722-0850-30
Buprenorphine and Naloxone	Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1	TabletSublingual	Camber Pharmaceuticals, Inc.	31722-851	31722-0851-30
Buprenorphine and Naloxone	Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride .5 mg/1	FilmBuccal, Sublingual	Aveva Drug Delivery Systems Inc.	3215-6521	03215-6521-30

All 51 Buprenorphine and Naloxone NDCs

Other NDCs under ANDA 205806

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

FDA NDC Directory listings under ANDA 205806
Product	Strength	Form · route	Labeler	Product NDC
Buprenorphine and Naloxone	Buprenorphine hydrochloride 12 mg/1; Naloxone 3 mg/1	Film, SolubleBuccal, Sublingual	Dr.Reddys Laboratories Inc	43598-581