BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE NDC 76420-534

NDC codes

FDA NDC Directory

Product NDC (as listed)76420-534Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76420-0534Add 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
76420-534-30	76420053430	30 TABLET in 1 BOTTLE, PLASTIC (76420-534-30)Marketed from Jan 27, 2023

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 HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE
Generic name (nonproprietary): buprenorphine hydrochloride and naloxone hydrochloride dihydrate
Active ingredients: Buprenorphine hydrochloride — 8 mg/1Naloxone hydrochloride dihydrate — 2 mg/1
Dosage form: Tablet
Route: Sublingual
Labeler: Asclemed USA, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209069
Marketing start: Jan 22, 2021
Listing expires: Dec 31, 2026
DEA schedule: CIII
Other FDA classes: Opioid Antagonists (Mechanism)Partial Opioid Agonists (Mechanism)
Identifiers: Product ID 76420-534_f33905ee-0218-1314-e053-2a95a90a25c7SPL ID f33905ee-0218-1314-e053-2a95a90a25c7SPL set ID 597cbc69-84b1-4255-bed9-53d0c6dc2134RxCUI 351267UNII 56W8MW3EN1, 5Q187997EE
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. Sublingual products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N476420053430 followed by a unit qualifier and the quantity

Package 76420-0534-30. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 209069

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

FDA NDC Directory listings under ANDA 209069
Product	Strength	Form · route	Labeler	Product NDC
BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE	Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1	TabletSublingual	Bryant Ranch Prepack	71335-1858
BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE	Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1	TabletSublingual	Redpharm Drug	67296-2191
BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE	Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1	TabletSublingual	Accord Healthcare, Inc	16729-549
BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE	Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1	TabletSublingual	Clinical Solutions Wholesale, LLC	58118-0549
BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE	Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1	TabletSublingual	Accord Healthcare, Inc	16729-550