Zubsolv

Product NDC: 54123-914
11-digit product format: 541230914
Labeler code: 54123
Product ID: 54123-914_8c67e97f-118f-4226-972a-a9031ef6f5ce
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: buprenorphine hydrochloride and naloxone hydrochloride
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: SUBLINGUAL
Labeler: Orexo US, Inc.
Application: NDA204242
Marketing category: NDA
Marketing start: 2013-07-04
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: 2026-12-31
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: 2026-12-31

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5f5cfcfe-d52b-49e6-8fe4-550477332dd2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
68654759-f50b-79ef-24c5-544d94fe7d87	Product name	3	20251114
c955d208-c333-9bd7-be34-d7e12986d44e	Product name	6	20250626
e5f98bfa-66d5-4c3a-b22d-9543d3bee304	Product name	1	20250204
caa6391e-3db3-c912-335f-61b5fc00aa12	Product name	9	20240110
08a295bb-88df-4ab0-a120-a75a789a74f1	Product name	1	20231013
65a3bc34-04ff-4cf1-aad9-c7d92a062f6d	Product name	1	20231003
e951cdf3-f269-4d97-a7d5-c1c3d7283a7d	Product name	3	20230313
ab841ac7-728a-4fc9-be0a-35b96cecbf39	Product name	4	20230306
100316cc-94a9-474e-97ad-9b5c6ddec605	Product name	5	20230125
f327b80c-8fa2-404b-838a-df3eec141cf2	Product name	1	20221212
d4aa2fcf-79c3-4b5f-a00e-1a8e26e00119	Product name	1	20220511
539bc5d3-546b-4af6-9c31-058ce6c459d3	Product name	2	20220210
b871fccd-1de6-4c7f-b9e5-045304641ee6	Product name	8	20220118
43b1efe2-1425-4b3e-b3a2-57d40f8478b9	Product name	1	20211026
31e16ab2-c562-4617-a3e8-ed285320e16e	Product name	1	20180201
4c23a34c-e8fc-424c-8fa0-ee064ba6eaef	Product name	1	20170706
a5920611-4285-f024-69b9-39ff338b81ea	Product name	5	20170609
0b8c7273-1da3-495f-909a-7cf1e96d2361	Product name	1	20161212
3df867ed-9d48-45cf-bded-1394beaea0b1	Product name	3	20161206
973da5bf-b1f9-4de0-81ee-7ca066c98ca4	Product name	1	20160712
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
8a245632-e24f-4ccc-b671-995d89c96ebc	Product name	1	20141203

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54123-914-30	2021-02-17	C162847	48780-1	ba0f9c33-5bce-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use ZUBSOLV ® safely and effectively. See full prescribing information for ZUBSOLV. ZUBSOLV (buprenorphine and naloxone sublingual tablets), CIII Initial U.S. Approval: 2002
54123-914-30	2021-01-29	C162847	48780-1	ba0f9c33-5bce-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use ZUBSOLV ® safely and effectively. See full prescribing information for ZUBSOLV. ZUBSOLV (buprenorphine and naloxone sublingual tablets), CIII Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54123-914-30	Zubsolv	3 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	3		27
54123-914-30	Zubsolv	10 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	10		27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54123-914-30	EA - Each	54123-914	9f02ec42-6a2d-4392-95dd-ca5a83872add	1	2013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BUPRENORPHINE HYDROCHLORIDE	ACTIVE INGREDIENT	56W8MW3EN1	ZUBSOLV (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [OREXO US, INC.]	5
NALOXONE HYDROCHLORIDE	ACTIVE INGREDIENT	F850569PQR	ZUBSOLV (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [OREXO US, INC.]	5
BUPRENORPHINE	ACTIVE MOIETY	40D3SCR4GZ	ZUBSOLV (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [OREXO US, INC.]	5
NALOXONE	ACTIVE MOIETY	36B82AMQ7N	ZUBSOLV (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [OREXO US, INC.]	5
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	ZUBSOLV (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [OREXO US, INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZUBSOLV (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [OREXO US, INC.]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ZUBSOLV (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [OREXO US, INC.]	5
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	ZUBSOLV (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [OREXO US, INC.]	5
MENTHOL, UNSPECIFIED FORM	INACTIVE INGREDIENT	L7T10EIP3A	ZUBSOLV (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [OREXO US, INC.]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ZUBSOLV (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [OREXO US, INC.]	5
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	ZUBSOLV (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [OREXO US, INC.]	5
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	ZUBSOLV (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [OREXO US, INC.]	5
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	ZUBSOLV (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [OREXO US, INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54123-914	ZUBSOLV (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [OREXO US, INC.]	26	Current NDC, Legacy NDC, 2 package rows	20250524_5f5cfcfe-d52b-49e6-8fe4-550477332dd2.zip

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
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 ndc (product): 54123-914

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1864412	buprenorphine 0.7 MG / naloxone 0.18 MG Sublingual Tablet	PSN	5f5cfcfe-d52b-49e6-8fe4-550477332dd2	27
1431076	buprenorphine 1.4 MG / naloxone 0.36 MG Sublingual Tablet	PSN	5f5cfcfe-d52b-49e6-8fe4-550477332dd2	27
1597568	buprenorphine 11.4 MG / naloxone 2.9 MG Sublingual Tablet	PSN	5f5cfcfe-d52b-49e6-8fe4-550477332dd2	27
1666338	buprenorphine 2.9 MG / naloxone 0.71 MG Sublingual Tablet	PSN	5f5cfcfe-d52b-49e6-8fe4-550477332dd2	27
1431102	buprenorphine 5.7 MG / naloxone 1.4 MG Sublingual Tablet	PSN	5f5cfcfe-d52b-49e6-8fe4-550477332dd2	27
1597573	buprenorphine 8.6 MG / naloxone 2.1 MG Sublingual Tablet	PSN	5f5cfcfe-d52b-49e6-8fe4-550477332dd2	27
1864414	Zubsolv 0.7 MG / 0.18 MG Sublingual Tablet	PSN	5f5cfcfe-d52b-49e6-8fe4-550477332dd2	27
1431083	zubsolv 1.4 MG / 0.36 MG Sublingual Tablet	PSN	5f5cfcfe-d52b-49e6-8fe4-550477332dd2	27
1597570	zubsolv 11.4 MG / 2.9 MG Sublingual Tablet	PSN	5f5cfcfe-d52b-49e6-8fe4-550477332dd2	27
1666385	zubsolv 2.9 MG / 0.71 MG Sublingual Tablet	PSN	5f5cfcfe-d52b-49e6-8fe4-550477332dd2	27
1431104	zubsolv 5.7 MG / 1.4 MG Sublingual Tablet	PSN	5f5cfcfe-d52b-49e6-8fe4-550477332dd2	27
1597575	zubsolv 8.6 MG / 2.1 MG Sublingual Tablet	PSN	5f5cfcfe-d52b-49e6-8fe4-550477332dd2	27
1864414	buprenorphine 0.7 MG / naloxone 0.18 MG Sublingual Tablet [Zubsolv]	SBD	5f5cfcfe-d52b-49e6-8fe4-550477332dd2	27
1431083	buprenorphine 1.4 MG / naloxone 0.36 MG Sublingual Tablet [Zubsolv]	SBD	5f5cfcfe-d52b-49e6-8fe4-550477332dd2	27
1597570	buprenorphine 11.4 MG / naloxone 2.9 MG Sublingual Tablet [Zubsolv]	SBD	5f5cfcfe-d52b-49e6-8fe4-550477332dd2	27
1666385	buprenorphine 2.9 MG / naloxone 0.71 MG Sublingual Tablet [Zubsolv]	SBD	5f5cfcfe-d52b-49e6-8fe4-550477332dd2	27
1431104	buprenorphine 5.7 MG / naloxone 1.4 MG Sublingual Tablet [Zubsolv]	SBD	5f5cfcfe-d52b-49e6-8fe4-550477332dd2	27
1597575	buprenorphine 8.6 MG / naloxone 2.1 MG Sublingual Tablet [Zubsolv]	SBD	5f5cfcfe-d52b-49e6-8fe4-550477332dd2	27
1864412	buprenorphine 0.7 MG / naloxone 0.18 MG Sublingual Tablet	SCD	5f5cfcfe-d52b-49e6-8fe4-550477332dd2	27
1431076	buprenorphine 1.4 MG / naloxone 0.36 MG Sublingual Tablet	SCD	5f5cfcfe-d52b-49e6-8fe4-550477332dd2	27
1597568	buprenorphine 11.4 MG / naloxone 2.9 MG Sublingual Tablet	SCD	5f5cfcfe-d52b-49e6-8fe4-550477332dd2	27
1666338	buprenorphine 2.9 MG / naloxone 0.71 MG Sublingual Tablet	SCD	5f5cfcfe-d52b-49e6-8fe4-550477332dd2	27
1431102	buprenorphine 5.7 MG / naloxone 1.4 MG Sublingual Tablet	SCD	5f5cfcfe-d52b-49e6-8fe4-550477332dd2	27
1597573	buprenorphine 8.6 MG / naloxone 2.1 MG Sublingual Tablet	SCD	5f5cfcfe-d52b-49e6-8fe4-550477332dd2	27
1431076	buprenorphine (as buprenorphine hydrochloride) 1.4 MG / naloxone (as naloxone hydrochloride dihydrate) 0.36 MG Sublingual Tablet	SY	5f5cfcfe-d52b-49e6-8fe4-550477332dd2	27
1597568	buprenorphine (as buprenorphine hydrochloride) 11.4 MG / naloxone (as naloxone hydrochloride dihydrate) 2.9 MG Sublingual Tablet	SY	5f5cfcfe-d52b-49e6-8fe4-550477332dd2	27
1666338	buprenorphine (as buprenorphine hydrochloride) 2.9 MG / naloxone (as naloxone hydrochloride dihydrate) 0.71 MG Sublingual Tablet	SY	5f5cfcfe-d52b-49e6-8fe4-550477332dd2	27
1431102	buprenorphine (as buprenorphine hydrochloride) 5.7 MG / naloxone (as naloxone hydrochloride dihydrate) 1.4 MG Sublingual Tablet	SY	5f5cfcfe-d52b-49e6-8fe4-550477332dd2	27
1597573	buprenorphine (as buprenorphine hydrochloride) 8.6 MG / naloxone (as naloxone hydrochloride dihydrate) 2.1 MG Sublingual Tablet	SY	5f5cfcfe-d52b-49e6-8fe4-550477332dd2	27
1597570	Zubsolv (buprenorphine 11.4 MG / naloxone 2.9 MG) Sublingual Tablet	SY	5f5cfcfe-d52b-49e6-8fe4-550477332dd2	27
1597575	Zubsolv (buprenorphine 8.6 MG / naloxone 2.1 MG) Sublingual Tablet	SY	5f5cfcfe-d52b-49e6-8fe4-550477332dd2	27
1864414	Zubsolv 0.7 MG / 0.18 MG Sublingual Tablet	SY	5f5cfcfe-d52b-49e6-8fe4-550477332dd2	27
1431083	Zubsolv 1.4/0.36 (buprenorphine HCl / naloxone HCl dihydrate) Sublingual Tablet	SY	5f5cfcfe-d52b-49e6-8fe4-550477332dd2	27
1431083	Zubsolv 1.4/0.36 Sublingual Tablet	SY	5f5cfcfe-d52b-49e6-8fe4-550477332dd2	27
1666385	Zubsolv 2.9/0.71 Sublingual Tablet	SY	5f5cfcfe-d52b-49e6-8fe4-550477332dd2	27
1431104	Zubsolv 5.7/1.4 (buprenorphine HCl / naloxone HCl dihydrate) Sublingual Tablet	SY	5f5cfcfe-d52b-49e6-8fe4-550477332dd2	27
1431104	Zubsolv 5.7/1.4 Sublingual Tablet	SY	5f5cfcfe-d52b-49e6-8fe4-550477332dd2	27

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54123-914-30	54123091430	3 BLISTER PACK in 1 CARTON (54123-914-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	3 blister pack	2013-07-04	0000-00-00	No	No	Current