Home NDC 71335-1858 BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE
Product NDC 71335-1858
11-digit product format 713351858
Labeler code 71335
Product ID 71335-1858_9bc52e26-1d52-4d68-894a-d3b300f5f090
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE
Dosage form TABLET
Route SUBLINGUAL
Labeler Bryant Ranch Prepack
Application ANDA209069
Marketing category ANDA
Marketing start 2021-01-22
Substance BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
Active strength 8; 2 mg/1; mg/1
Pharmacologic classes Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
DEA schedule CIII
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209069-001 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 2MG BASE;EQ 0.5MG BASE TABLET / SUBLINGUAL AB 2020-07-17 A209069-002 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 8MG BASE;EQ 2MG BASE TABLET / SUBLINGUAL AB 2020-07-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A209069-001 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE EQ 2MG BASE;EQ 0.5MG BASE TABLET / SUBLINGUAL AB 2020-07-17 a50c72e98297…2026-08-01 22:54:32 2026-06 A209069-002 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE EQ 8MG BASE;EQ 2MG BASE TABLET / SUBLINGUAL AB 2020-07-17 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A209069-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 A209069-002 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE Clinical Solutions Wholesale, LLC 8f2b94dc-f42f-45d5-8274-9e748ec20ef0 2026-03-05 Warnings, Adverse reactions Exact identifier application applno (ANDA): 209069 application number: ANDA209069 BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE Redpharm Drug 44f2e26f-4586-5204-e063-6394a90a47d5 2026-01-23 Warnings, Adverse reactions Exact identifier application applno (ANDA): 209069 application number: ANDA209069 BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE Bryant Ranch Prepack 53457b0d-3462-489e-8cf5-7cdc2ecffb48 2023-11-16 Warnings, Adverse reactions Exact identifier application applno (ANDA): 209069 application number: ANDA209069 ndc (product): 71335-1858 BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE Accord Healthcare, Inc 35d29e9b-9950-452a-a795-5a7514f0edfd 2023-05-03 Warnings, Adverse reactions Exact identifier application applno (ANDA): 209069 application number: ANDA209069 BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE Asclemed USA, Inc. 597cbc69-84b1-4255-bed9-53d0c6dc2134 2023-01-27 Warnings, Adverse reactions Exact identifier application applno (ANDA): 209069 application number: ANDA209069
Additional Listing Data#
Finished product Yes
Brand name base BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUPRENORPHINE HYDROCHLORIDE 8 mg/1 NALOXONE HYDROCHLORIDE DIHYDRATE 2 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 56W8MW3EN1 Internal UNII lookup 5Q187997EE Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 351267 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71335-1858-0 BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE 42 in 1 BOTTLE, PLASTIC TABLET 42 104 71335-1858-1 BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE 30 in 1 BOTTLE, PLASTIC TABLET 30 104 71335-1858-2 BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE 60 in 1 BOTTLE, PLASTIC TABLET 60 104 71335-1858-3 BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE 90 in 1 BOTTLE, PLASTIC TABLET 90 104 71335-1858-4 BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE 120 in 1 BOTTLE, PLASTIC TABLET 120 104 71335-1858-5 BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE 14 in 1 BOTTLE, PLASTIC TABLET 14 104 71335-1858-6 BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE 28 in 1 BOTTLE, PLASTIC TABLET 28 104 71335-1858-7 BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE 6 in 1 BOTTLE, PLASTIC TABLET 6 104 71335-1858-8 BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE 10 in 1 BOTTLE, PLASTIC TABLET 10 104 71335-1858-9 BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE 21 in 1 BOTTLE, PLASTIC TABLET 21 104
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-1858 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE TABLET [BRYANT RANCH PREPACK] 104 Current NDC, Legacy NDC, 10 package rows 20231117_53457b0d-3462-489e-8cf5-7cdc2ecffb48.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71335-1858-0 71335185800 42 TABLET in 1 BOTTLE, PLASTIC (71335-1858-0) 42 tablet 2022-02-14 0000-00-00 No No Current 71335-1858-1 71335185801 30 TABLET in 1 BOTTLE, PLASTIC (71335-1858-1) 30 tablet 2021-05-07 0000-00-00 No No Current 71335-1858-2 71335185802 60 TABLET in 1 BOTTLE, PLASTIC (71335-1858-2) 60 tablet 2021-06-08 0000-00-00 No No Current 71335-1858-3 71335185803 90 TABLET in 1 BOTTLE, PLASTIC (71335-1858-3) 90 tablet 2022-02-14 0000-00-00 No No Current 71335-1858-4 71335185804 120 TABLET in 1 BOTTLE, PLASTIC (71335-1858-4) 120 tablet 2022-02-14 0000-00-00 No No Current 71335-1858-5 71335185805 14 TABLET in 1 BOTTLE, PLASTIC (71335-1858-5) 14 tablet 2022-02-14 0000-00-00 No No Current 71335-1858-6 71335185806 28 TABLET in 1 BOTTLE, PLASTIC (71335-1858-6) 28 tablet 2022-02-14 0000-00-00 No No Current 71335-1858-7 71335185807 6 TABLET in 1 BOTTLE, PLASTIC (71335-1858-7) 6 tablet 2022-02-14 0000-00-00 No No Current 71335-1858-8 71335185808 10 TABLET in 1 BOTTLE, PLASTIC (71335-1858-8) 10 tablet 2022-02-14 0000-00-00 No No Current 71335-1858-9 71335185809 21 TABLET in 1 BOTTLE, PLASTIC (71335-1858-9) 21 tablet 2022-02-14 0000-00-00 No No Current