Zubsolv

Product NDC: 82111-206
Requested package NDC: 82111-206-30
11-digit product format: 821110206
Labeler code: 82111
Product ID: 82111-206_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: 11.4; 2.9 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	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.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N204242-001	8658198	2027-12-03	U-1494	Drug product	2014-03-25
N204242-001	8470361	2030-05-22	U-1425	Drug product	2013-07-10
N204242-001	10946010	2032-09-18		Drug product	2021-03-30
N204242-001	11020388	2032-09-18	U-3131	Drug product	2021-06-21
N204242-001	11433066	2032-09-18	U-3131		2022-09-20
N204242-001	8940330	2032-09-18		Drug product	2015-02-05
N204242-001	9259421	2032-09-18		Drug product	2016-03-10
N204242-001	9439900	2032-09-18		Drug product	2016-10-03
N204242-002	8658198	2027-12-03	U-1494	Drug product	2014-03-25
N204242-002	8470361	2030-05-22	U-1425	Drug product	2013-07-10
N204242-002	10874661	2032-09-18		Drug product	2021-01-25
N204242-002	10946010	2032-09-18		Drug product	2021-03-30
N204242-002	11020387	2032-09-18	U-3131	Drug product	2021-06-21
N204242-002	11020388	2032-09-18	U-3131	Drug product	2021-06-21
N204242-002	11433066	2032-09-18	U-3131		2022-09-20
N204242-002	8940330	2032-09-18		Drug product	2015-02-05
N204242-002	9259421	2032-09-18		Drug product	2016-03-10
N204242-002	9439900	2032-09-18		Drug product	2016-10-03
N204242-003	8658198	2027-12-03	U-1494	Drug product
N204242-003	8470361	2030-05-22	U-1425	Drug product	2013-07-10
N204242-003	10946010	2032-09-18		Drug product	2021-03-30
N204242-003	11020387	2032-09-18	U-3131	Drug product	2021-06-21
N204242-003	11020388	2032-09-18	U-3131	Drug product	2021-06-21
N204242-003	11433066	2032-09-18	U-3131		2022-09-20
N204242-003	8940330	2032-09-18		Drug product	2015-02-05
N204242-003	9259421	2032-09-18		Drug product	2016-03-10
N204242-003	9439900	2032-09-18		Drug product	2016-10-03
N204242-004	8658198	2027-12-03	U-1494	Drug product	2015-01-09
N204242-004	8470361	2030-05-22	U-1425	Drug product	2013-07-10
N204242-004	10946010	2032-09-18		Drug product	2021-03-30
N204242-004	11020387	2032-09-18	U-3131	Drug product	2021-06-21
N204242-004	11020388	2032-09-18	U-3131	Drug product	2021-06-21
N204242-004	11433066	2032-09-18	U-3131		2022-09-20
N204242-004	8940330	2032-09-18		Drug product	2015-02-05
N204242-004	9259421	2032-09-18		Drug product	2016-03-10
N204242-004	9439900	2032-09-18		Drug product	2016-10-03
N204242-005	8658198	2027-12-03	U-1494	Drug product	2015-06-29
N204242-005	8470361	2030-05-22	U-1425	Drug product	2015-06-29
N204242-005	10946010	2032-09-18		Drug product	2021-03-30
N204242-005	11020387	2032-09-18	U-3131	Drug product	2021-06-21
N204242-005	11020388	2032-09-18	U-3131	Drug product	2021-06-21
N204242-005	11433066	2032-09-18	U-3131		2022-09-20
N204242-005	8940330	2032-09-18		Drug product	2015-06-29
N204242-005	9259421	2032-09-18		Drug product	2016-03-10
N204242-005	9439900	2032-09-18		Drug product	2016-10-03
N204242-006	8658198	2027-12-03	U-1494	Drug product	2016-10-26
N204242-006	8470361	2030-05-22	U-1425	Drug product	2016-10-26
N204242-006	10946010	2032-09-18		Drug product	2021-03-30
N204242-006	11020388	2032-09-18	U-3131	Drug product	2021-06-21
N204242-006	8940330	2032-09-18		Drug product	2016-10-26
N204242-006	9259421	2032-09-18		Drug product	2016-10-26

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	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	11.4 mg/1
NALOXONE HYDROCHLORIDE	2.9 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
F850569PQR	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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
57583c1d-9c44-4503-917d-68dba7377bd1	Available on FDA.report

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zubsolv	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	Edenbridge Pharmaceuticals LLC.	57583c1d-9c44-4503-917d-68dba7377bd1	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204242 application number: NDA204242 ndc (package): 82111-206-30 ndc (product): 82111-206 ndc11 (package): 82111020630
Zubsolv	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	Orexo US, Inc.	5f5cfcfe-d52b-49e6-8fe4-550477332dd2	2025-12-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204242 application number: NDA204242

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
56W8MW3EN1	BUPRENORPHINE HYDROCHLORIDE	53152-21-9	BUPRENORPHINE HYDROCHLORIDE
F850569PQR	NALOXONE HYDROCHLORIDE	357-08-4	NALOXONE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82111-206-30	82111020630	3 BLISTER PACK in 1 CARTON (82111-206-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	3 blister pack	2026-06-12	No	No	Current