Home NDC 82111-202 Zubsolv
Product NDC 82111-202
11-digit product format 821110202
Labeler code 82111
Product ID 82111-202_57583c1d-9c44-4503-917d-68dba7377bd1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name buprenorphine hydrochloride and naloxone hydrochloride
Dosage form TABLET, ORALLY DISINTEGRATING
Route SUBLINGUAL
Labeler Edenbridge Pharmaceuticals LLC.
Application NDA204242
Marketing category NDA
Marketing start 2026-06-12
Substance BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Active strength 1.4; .36 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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N204242-001 ZUBSOLV BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 1.4MG BASE;EQ 0.36MG BASE TABLET / SUBLINGUAL RLD 2013-07-03 N204242-002 ZUBSOLV BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 5.7MG BASE;EQ 1.4MG BASE TABLET / SUBLINGUAL RLD 2013-07-03 N204242-003 ZUBSOLV BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 8.6MG BASE;EQ 2.1MG BASE TABLET / SUBLINGUAL RLD 2014-12-11 N204242-004 ZUBSOLV BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 11.4MG BASE;EQ 2.9MG BASE TABLET / SUBLINGUAL RLD, RS 2014-12-11 N204242-005 ZUBSOLV BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 2.9MG BASE;EQ 0.71MG BASE TABLET / SUBLINGUAL RLD 2015-06-04 N204242-006 ZUBSOLV BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 0.7MG BASE;EQ 0.18MG BASE TABLET / SUBLINGUAL RLD 2016-10-04
Orange Book patents# Current patent rows page 1 of 1 · 51 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.
Product history page 1 of 7 · 258 observed 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 2026-09-14 22:38:34 2026-08 N204242-001 ZUBSOLV EQ 1.4MG BASE;EQ 0.36MG BASE TABLET / SUBLINGUAL RLD 2013-07-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-002 ZUBSOLV EQ 5.7MG BASE;EQ 1.4MG BASE TABLET / SUBLINGUAL RLD 2013-07-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-003 ZUBSOLV EQ 8.6MG BASE;EQ 2.1MG BASE TABLET / SUBLINGUAL RLD 2014-12-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-004 ZUBSOLV EQ 11.4MG BASE;EQ 2.9MG BASE TABLET / SUBLINGUAL RLD, RS 2014-12-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-005 ZUBSOLV EQ 2.9MG BASE;EQ 0.71MG BASE TABLET / SUBLINGUAL RLD 2015-06-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-006 ZUBSOLV EQ 0.7MG BASE;EQ 0.18MG BASE TABLET / SUBLINGUAL RLD 2016-10-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 N204242-001 ZUBSOLV EQ 1.4MG BASE;EQ 0.36MG BASE TABLET / SUBLINGUAL RLD 2013-07-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204242-002 ZUBSOLV EQ 5.7MG BASE;EQ 1.4MG BASE TABLET / SUBLINGUAL RLD 2013-07-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204242-003 ZUBSOLV EQ 8.6MG BASE;EQ 2.1MG BASE TABLET / SUBLINGUAL RLD 2014-12-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204242-004 ZUBSOLV EQ 11.4MG BASE;EQ 2.9MG BASE TABLET / SUBLINGUAL RLD, RS 2014-12-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204242-005 ZUBSOLV EQ 2.9MG BASE;EQ 0.71MG BASE TABLET / SUBLINGUAL RLD 2015-06-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204242-006 ZUBSOLV EQ 0.7MG BASE;EQ 0.18MG BASE TABLET / SUBLINGUAL RLD 2016-10-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N204242-001 ZUBSOLV EQ 1.4MG BASE;EQ 0.36MG BASE TABLET / SUBLINGUAL RLD 2013-07-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204242-002 ZUBSOLV EQ 5.7MG BASE;EQ 1.4MG BASE TABLET / SUBLINGUAL RLD 2013-07-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204242-003 ZUBSOLV EQ 8.6MG BASE;EQ 2.1MG BASE TABLET / SUBLINGUAL RLD 2014-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204242-004 ZUBSOLV EQ 11.4MG BASE;EQ 2.9MG BASE TABLET / SUBLINGUAL RLD, RS 2014-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204242-005 ZUBSOLV EQ 2.9MG BASE;EQ 0.71MG BASE TABLET / SUBLINGUAL RLD 2015-06-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204242-006 ZUBSOLV EQ 0.7MG BASE;EQ 0.18MG BASE TABLET / SUBLINGUAL RLD 2016-10-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204242-001 ZUBSOLV EQ 1.4MG BASE;EQ 0.36MG BASE TABLET / SUBLINGUAL RLD 2013-07-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204242-002 ZUBSOLV EQ 5.7MG BASE;EQ 1.4MG BASE TABLET / SUBLINGUAL RLD 2013-07-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204242-003 ZUBSOLV EQ 8.6MG BASE;EQ 2.1MG BASE TABLET / SUBLINGUAL RLD 2014-12-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204242-004 ZUBSOLV EQ 11.4MG BASE;EQ 2.9MG BASE TABLET / SUBLINGUAL RLD, RS 2014-12-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204242-005 ZUBSOLV EQ 2.9MG BASE;EQ 0.71MG BASE TABLET / SUBLINGUAL RLD 2015-06-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204242-006 ZUBSOLV EQ 0.7MG BASE;EQ 0.18MG BASE TABLET / SUBLINGUAL RLD 2016-10-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204242-001 ZUBSOLV EQ 1.4MG BASE;EQ 0.36MG BASE TABLET / SUBLINGUAL RLD 2013-07-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204242-002 ZUBSOLV EQ 5.7MG BASE;EQ 1.4MG BASE TABLET / SUBLINGUAL RLD 2013-07-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204242-003 ZUBSOLV EQ 8.6MG BASE;EQ 2.1MG BASE TABLET / SUBLINGUAL RLD 2014-12-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204242-004 ZUBSOLV EQ 11.4MG BASE;EQ 2.9MG BASE TABLET / SUBLINGUAL RLD, RS 2014-12-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204242-005 ZUBSOLV EQ 2.9MG BASE;EQ 0.71MG BASE TABLET / SUBLINGUAL RLD 2015-06-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204242-006 ZUBSOLV EQ 0.7MG BASE;EQ 0.18MG BASE TABLET / SUBLINGUAL RLD 2016-10-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204242-001 ZUBSOLV EQ 1.4MG BASE;EQ 0.36MG BASE TABLET / SUBLINGUAL RLD 2013-07-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204242-002 ZUBSOLV EQ 5.7MG BASE;EQ 1.4MG BASE TABLET / SUBLINGUAL RLD 2013-07-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204242-003 ZUBSOLV EQ 8.6MG BASE;EQ 2.1MG BASE TABLET / SUBLINGUAL RLD 2014-12-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204242-004 ZUBSOLV EQ 11.4MG BASE;EQ 2.9MG BASE TABLET / SUBLINGUAL RLD, RS 2014-12-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204242-005 ZUBSOLV EQ 2.9MG BASE;EQ 0.71MG BASE TABLET / SUBLINGUAL RLD 2015-06-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204242-006 ZUBSOLV EQ 0.7MG BASE;EQ 0.18MG BASE TABLET / SUBLINGUAL RLD 2016-10-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204242-001 ZUBSOLV EQ 1.4MG BASE;EQ 0.36MG BASE TABLET / SUBLINGUAL RLD 2013-07-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204242-002 ZUBSOLV EQ 5.7MG BASE;EQ 1.4MG BASE TABLET / SUBLINGUAL RLD 2013-07-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204242-003 ZUBSOLV EQ 8.6MG BASE;EQ 2.1MG BASE TABLET / SUBLINGUAL RLD 2014-12-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204242-004 ZUBSOLV EQ 11.4MG BASE;EQ 2.9MG BASE TABLET / SUBLINGUAL RLD, RS 2014-12-11 b8a1b40f171c…
Observed Orange Book patent history# Patent history page 1 of 52 · 2,052 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N204242-001 8658198 2027-12-03 U-1494 Drug product 2014-03-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-001 8470361 2030-05-22 U-1425 Drug product 2013-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-001 10946010 2032-09-18 Drug product 2021-03-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-001 11020388 2032-09-18 U-3131 Drug product 2021-06-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-001 11433066 2032-09-18 U-3131 2022-09-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-001 8940330 2032-09-18 Drug product 2015-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-001 9259421 2032-09-18 Drug product 2016-03-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-001 9439900 2032-09-18 Drug product 2016-10-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-002 8658198 2027-12-03 U-1494 Drug product 2014-03-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-002 8470361 2030-05-22 U-1425 Drug product 2013-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-002 10874661 2032-09-18 Drug product 2021-01-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-002 10946010 2032-09-18 Drug product 2021-03-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-002 11020387 2032-09-18 U-3131 Drug product 2021-06-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-002 11020388 2032-09-18 U-3131 Drug product 2021-06-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-002 11433066 2032-09-18 U-3131 2022-09-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-002 8940330 2032-09-18 Drug product 2015-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-002 9259421 2032-09-18 Drug product 2016-03-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-002 9439900 2032-09-18 Drug product 2016-10-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-003 8658198 2027-12-03 U-1494 Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-003 8470361 2030-05-22 U-1425 Drug product 2013-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-003 10946010 2032-09-18 Drug product 2021-03-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-003 11020387 2032-09-18 U-3131 Drug product 2021-06-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-003 11020388 2032-09-18 U-3131 Drug product 2021-06-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-003 11433066 2032-09-18 U-3131 2022-09-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-003 8940330 2032-09-18 Drug product 2015-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-003 9259421 2032-09-18 Drug product 2016-03-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-003 9439900 2032-09-18 Drug product 2016-10-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-004 8658198 2027-12-03 U-1494 Drug product 2015-01-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-004 8470361 2030-05-22 U-1425 Drug product 2013-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-004 10946010 2032-09-18 Drug product 2021-03-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-004 11020387 2032-09-18 U-3131 Drug product 2021-06-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-004 11020388 2032-09-18 U-3131 Drug product 2021-06-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-004 11433066 2032-09-18 U-3131 2022-09-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-004 8940330 2032-09-18 Drug product 2015-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-004 9259421 2032-09-18 Drug product 2016-03-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-004 9439900 2032-09-18 Drug product 2016-10-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-005 8658198 2027-12-03 U-1494 Drug product 2015-06-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-005 8470361 2030-05-22 U-1425 Drug product 2015-06-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-005 10946010 2032-09-18 Drug product 2021-03-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204242-005 11020387 2032-09-18 U-3131 Drug product 2021-06-21 84e616aacf4f…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Zubsolv
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUPRENORPHINE HYDROCHLORIDE 1.4 mg/1 NALOXONE HYDROCHLORIDE .36 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F850569PQR Internal UNII lookup 56W8MW3EN1 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 12 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1431076 Internal RxNorm lookup 1431083 Internal RxNorm lookup 1431102 Internal RxNorm lookup 1431104 Internal RxNorm lookup 1597568 Internal RxNorm lookup 1597570 Internal RxNorm lookup 1597573 Internal RxNorm lookup 1597575 Internal RxNorm lookup 1666338 Internal RxNorm lookup 1666385 Internal RxNorm lookup 1864412 Internal RxNorm lookup 1864414 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82111-202-30 82111020230 3 BLISTER PACK in 1 CARTON (82111-202-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK 3 blister pack 2026-06-12 No No Current