Application 022328

Type: NDA
Sponsor: PURDUE PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	INTERMEZZO	ZOLPIDEM TARTRATE	TABLET;SUBLINGUAL	1.75MG	Yes	No
002	INTERMEZZO	ZOLPIDEM TARTRATE	TABLET;SUBLINGUAL	3.5MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N022328-001	INTERMEZZO	ZOLPIDEM TARTRATE	1.75MG	TABLET / SUBLINGUAL		RLD	2011-11-23
N022328-002	INTERMEZZO	ZOLPIDEM TARTRATE	3.5MG	TABLET / SUBLINGUAL		RLD	2011-11-23

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022328-001	7658945	2027-04-15	U-1194	Drug product	2011-11-29
N022328-001	8242131	2029-08-20	U-1266		2012-08-15
N022328-002	7658945	2027-04-15	U-1194	Drug product
N022328-002	8242131	2029-08-20	U-1266

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 3 · 86 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	N022328-001	INTERMEZZO	1.75MG	TABLET / SUBLINGUAL	RLD	2011-11-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022328-002	INTERMEZZO	3.5MG	TABLET / SUBLINGUAL	RLD	2011-11-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022328-001	INTERMEZZO	1.75MG	TABLET / SUBLINGUAL	RLD	2011-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022328-002	INTERMEZZO	3.5MG	TABLET / SUBLINGUAL	RLD	2011-11-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022328-001	INTERMEZZO	1.75MG	TABLET / SUBLINGUAL	RLD	2011-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022328-002	INTERMEZZO	3.5MG	TABLET / SUBLINGUAL	RLD	2011-11-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022328-001	INTERMEZZO	1.75MG	TABLET / SUBLINGUAL	RLD	2011-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022328-002	INTERMEZZO	3.5MG	TABLET / SUBLINGUAL	RLD	2011-11-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022328-001	INTERMEZZO	1.75MG	TABLET / SUBLINGUAL	RLD	2011-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022328-002	INTERMEZZO	3.5MG	TABLET / SUBLINGUAL	RLD	2011-11-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022328-001	INTERMEZZO	1.75MG	TABLET / SUBLINGUAL	RLD	2011-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022328-002	INTERMEZZO	3.5MG	TABLET / SUBLINGUAL	RLD	2011-11-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022328-001	INTERMEZZO	1.75MG	TABLET / SUBLINGUAL	RLD	2011-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022328-002	INTERMEZZO	3.5MG	TABLET / SUBLINGUAL	RLD	2011-11-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022328-001	INTERMEZZO	1.75MG	TABLET / SUBLINGUAL	RLD	2011-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022328-002	INTERMEZZO	3.5MG	TABLET / SUBLINGUAL	RLD	2011-11-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022328-001	INTERMEZZO	1.75MG	TABLET / SUBLINGUAL	RLD	2011-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022328-002	INTERMEZZO	3.5MG	TABLET / SUBLINGUAL	RLD	2011-11-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022328-001	INTERMEZZO	1.75MG	TABLET / SUBLINGUAL	RLD	2011-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022328-002	INTERMEZZO	3.5MG	TABLET / SUBLINGUAL	RLD	2011-11-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022328-001	INTERMEZZO	1.75MG	TABLET / SUBLINGUAL	RLD	2011-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022328-002	INTERMEZZO	3.5MG	TABLET / SUBLINGUAL	RLD	2011-11-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022328-001	INTERMEZZO	1.75MG	TABLET / SUBLINGUAL	RLD	2011-11-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022328-002	INTERMEZZO	3.5MG	TABLET / SUBLINGUAL	RLD	2011-11-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022328-001	INTERMEZZO	1.75MG	TABLET / SUBLINGUAL	RLD	2011-11-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022328-002	INTERMEZZO	3.5MG	TABLET / SUBLINGUAL	RLD	2011-11-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022328-001	INTERMEZZO	1.75MG	TABLET / SUBLINGUAL	RLD	2011-11-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022328-002	INTERMEZZO	3.5MG	TABLET / SUBLINGUAL	RLD	2011-11-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022328-001	INTERMEZZO	1.75MG	TABLET / SUBLINGUAL	RLD	2011-11-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022328-002	INTERMEZZO	3.5MG	TABLET / SUBLINGUAL	RLD	2011-11-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022328-001	INTERMEZZO	1.75MG	TABLET / SUBLINGUAL	RLD	2011-11-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022328-002	INTERMEZZO	3.5MG	TABLET / SUBLINGUAL	RLD	2011-11-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022328-001	INTERMEZZO	1.75MG	TABLET / SUBLINGUAL	RLD	2011-11-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022328-002	INTERMEZZO	3.5MG	TABLET / SUBLINGUAL	RLD	2011-11-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022328-001	INTERMEZZO	1.75MG	TABLET / SUBLINGUAL	RLD	2011-11-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022328-002	INTERMEZZO	3.5MG	TABLET / SUBLINGUAL	RLD	2011-11-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022328-001	INTERMEZZO	1.75MG	TABLET / SUBLINGUAL	RLD	2011-11-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022328-002	INTERMEZZO	3.5MG	TABLET / SUBLINGUAL	RLD	2011-11-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022328-001	INTERMEZZO	1.75MG	TABLET / SUBLINGUAL	RLD	2011-11-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022328-002	INTERMEZZO	3.5MG	TABLET / SUBLINGUAL	RLD	2011-11-23	`74a2ff9319b5…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 328 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	N022328-001	7658945	2027-04-15	U-1194	Drug product	2011-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022328-001	8242131	2029-08-20	U-1266		2012-08-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022328-002	7658945	2027-04-15	U-1194	Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022328-002	8242131	2029-08-20	U-1266			`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022328-001	7658945	2027-04-15	U-1194	Drug product	2011-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022328-001	8242131	2029-08-20	U-1266		2012-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022328-002	7658945	2027-04-15	U-1194	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022328-002	8242131	2029-08-20	U-1266			`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022328-001	7658945	2027-04-15	U-1194	Drug product	2011-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022328-001	8242131	2029-08-20	U-1266		2012-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022328-002	7658945	2027-04-15	U-1194	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022328-002	8242131	2029-08-20	U-1266			`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022328-001	7682628	2025-02-16	U-1194		2011-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022328-001	8252809	2025-02-16		Drug product	2012-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022328-001	7658945	2027-04-15	U-1194	Drug product	2011-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022328-001	8242131	2029-08-20	U-1266		2012-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022328-002	7682628	2025-02-16	U-1194			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022328-002	8252809	2025-02-16		Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022328-002	7658945	2027-04-15	U-1194	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022328-002	8242131	2029-08-20	U-1266			`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022328-001	7682628	2025-02-16	U-1194		2011-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022328-001	8252809	2025-02-16		Drug product	2012-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022328-001	7658945	2027-04-15	U-1194	Drug product	2011-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022328-001	8242131	2029-08-20	U-1266		2012-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022328-002	7682628	2025-02-16	U-1194			`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022328-002	8252809	2025-02-16		Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022328-002	7658945	2027-04-15	U-1194	Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022328-002	8242131	2029-08-20	U-1266			`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022328-001	7682628	2025-02-16	U-1194		2011-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022328-001	8252809	2025-02-16		Drug product	2012-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022328-001	7658945	2027-04-15	U-1194	Drug product	2011-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022328-001	8242131	2029-08-20	U-1266		2012-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022328-002	7682628	2025-02-16	U-1194			`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022328-002	8252809	2025-02-16		Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022328-002	7658945	2027-04-15	U-1194	Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022328-002	8242131	2029-08-20	U-1266			`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022328-001	7682628	2025-02-16	U-1194		2011-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022328-001	8252809	2025-02-16		Drug product	2012-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022328-001	7658945	2027-04-15	U-1194	Drug product	2011-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022328-001	8242131	2029-08-20	U-1266		2012-08-15	`b8a1b40f171c…`

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 6 · 116 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Torrent Pharmaceuticals Limited	1584bad1-7bf4-4805-bdd9-7eb0fac92721	2026-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Breckenridge Pharmaceutical, Inc.	cbda91f7-4411-4016-80d6-0a349931956d	2026-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	A-S Medication Solutions	59cc61da-838e-4add-b2d6-42b2b283a000	2026-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	413b6f65-101e-e2cf-0802-711d080b851b	2026-08-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	REMEDYREPACK INC.	2abdcf77-d3ed-42bc-acd9-545aab75d567	2026-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	St. Mary's Medical Park Pharmacy	507225e2-80ba-18c4-e054-00144ff88e88	2026-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	TORRENT PHARMACEUTICALS LIMITED	9025a6f7-5501-4aba-875e-222ef39848c0	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	90201886-86a5-4c59-a4f1-98270d620731	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	bf99cd5c-9671-45a6-bda9-3dfc8252efdd	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	St. Mary's Medical Park Pharmacy	89cfb1d5-437c-4c13-8f9b-b6851ffba87b	2026-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	REMEDYREPACK INC.	cf3dcbde-b92a-4802-98e4-14f00abdf99e	2026-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	St. Mary's Medical Park Pharmacy	21767f56-ce92-2b8c-e063-6394a90a8b76	2026-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Umedica Laboratories USA Inc.	b49f6c18-e155-4728-a79a-9354e8c3c8f4	2026-05-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Golden State Medical Supply, Inc.	2b5cf535-ccdc-ecd7-e063-6394a90a726e	2026-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	REMEDYREPACK INC.	0f8488f3-851d-4111-af23-60f420aad0d6	2026-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	The ACME Laboratories Ltd.	5679ed64-8424-4e63-a3c9-91d80fff2ca6	2026-03-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	NuCare Pharmaceuticals,Inc.	bca751bb-5161-5a95-e053-2a95a90aa2dd	2026-02-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	A-S Medication Solutions	2556c804-7a5e-4dbd-aeef-a3ba3a247c39	2026-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
Zolpidem Tartrate	ZOLPIDEM TARTRATE	A-S Medication Solutions	f67ef513-1b2c-42fe-bf33-4c7e9db191a3	2026-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Calvin Scott & Co., Inc.	7da75d2b-905c-4fdf-bc53-1358c6477755	2026-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZOLPIDEM TARTRATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59011-255	Intermezzo	zolpidem tartrate	Purdue Pharma LP	NDA	Current
59011-255	Intermezzo	zolpidem tartrate	Purdue Pharma LP	NDA	Current
59011-256	Intermezzo	zolpidem tartrate	Purdue Pharma LP	NDA	Current
59011-256	Intermezzo	zolpidem tartrate	Purdue Pharma LP	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
59772	SUPPL	2019-08-20
59771	SUPPL	2019-08-20
59757	SUPPL	2019-08-20
57605	SUPPL	2019-02-14
57484	SUPPL	2019-02-07
29602	SUPPL	2015-09-15
17246	SUPPL	2015-09-14
23708	ORIG	2013-04-29
38584	SUPPL	2013-02-08
24284	ORIG	2012-09-05
21994	ORIG	2012-09-05
38583	ORIG	2011-11-28
7244	ORIG	2011-11-28