ZOLPIDEM TARTRATE

Product NDC: 40032-762
11-digit product format: 400320762
Labeler code: 40032
Product ID: 40032-762_207a5ac6-0a75-4c30-9af9-2d705101a342
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: zolpidem tartrate
Dosage form: TABLET
Route: SUBLINGUAL
Labeler: Novel Laboratories, Inc.
Application: ANDA204299
Marketing category: ANDA
Marketing start: 2016-03-22
Marketing end: 0000-00-00
Substance: ZOLPIDEM TARTRATE
Active strength: 2 mg/1
Pharmacologic classes: gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	40032-762		I	Inactivated by FDA		2026-08-03
excluded package	package	40032-762	40032-762-30	I	Inactivated by FDA		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	40032-762-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	40032-762-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	40032-762-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	40032-762-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	40032-762-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	40032-762-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	40032-762-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	40032-762-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	40032-762-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	40032-762-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	40032-762-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	40032-762-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	40032-762-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	40032-762-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	40032-762-30	`1332a3947898…`	`d4bfe170f9cd…`

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
A204299-001	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	1.75MG	TABLET / SUBLINGUAL	AB		2015-06-03
A204299-002	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	3.5MG	TABLET / SUBLINGUAL	AB	RS	2015-06-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A204299-001	AB
A204299-002	AB

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 · 82 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
2026-02-19 14:30 UTC	2026-02	A204299-001	ZOLPIDEM TARTRATE	1.75MG	TABLET / SUBLINGUAL	AB		2015-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204299-002	ZOLPIDEM TARTRATE	3.5MG	TABLET / SUBLINGUAL	AB	RS	2015-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204299-001	ZOLPIDEM TARTRATE	1.75MG	TABLET / SUBLINGUAL	AB		2015-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204299-002	ZOLPIDEM TARTRATE	3.5MG	TABLET / SUBLINGUAL	AB	RS	2015-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204299-001	ZOLPIDEM TARTRATE	1.75MG	TABLET / SUBLINGUAL	AB		2015-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204299-002	ZOLPIDEM TARTRATE	3.5MG	TABLET / SUBLINGUAL	AB	RS	2015-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204299-001	ZOLPIDEM TARTRATE	1.75MG	TABLET / SUBLINGUAL	AB		2015-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204299-002	ZOLPIDEM TARTRATE	3.5MG	TABLET / SUBLINGUAL	AB	RS	2015-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204299-001	ZOLPIDEM TARTRATE	1.75MG	TABLET / SUBLINGUAL	AB		2015-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204299-002	ZOLPIDEM TARTRATE	3.5MG	TABLET / SUBLINGUAL	AB	RS	2015-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204299-001	ZOLPIDEM TARTRATE	1.75MG	TABLET / SUBLINGUAL	AB		2015-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204299-002	ZOLPIDEM TARTRATE	3.5MG	TABLET / SUBLINGUAL	AB	RS	2015-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204299-001	ZOLPIDEM TARTRATE	1.75MG	TABLET / SUBLINGUAL	AB		2015-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204299-002	ZOLPIDEM TARTRATE	3.5MG	TABLET / SUBLINGUAL	AB	RS	2015-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204299-001	ZOLPIDEM TARTRATE	1.75MG	TABLET / SUBLINGUAL	AB		2015-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204299-002	ZOLPIDEM TARTRATE	3.5MG	TABLET / SUBLINGUAL	AB	RS	2015-06-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204299-001	ZOLPIDEM TARTRATE	1.75MG	TABLET / SUBLINGUAL	AB		2015-06-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204299-002	ZOLPIDEM TARTRATE	3.5MG	TABLET / SUBLINGUAL	AB	RS	2015-06-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204299-001	ZOLPIDEM TARTRATE	1.75MG	TABLET / SUBLINGUAL	AB		2015-06-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204299-002	ZOLPIDEM TARTRATE	3.5MG	TABLET / SUBLINGUAL	AB	RS	2015-06-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204299-001	ZOLPIDEM TARTRATE	1.75MG	TABLET / SUBLINGUAL	AB		2015-06-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204299-002	ZOLPIDEM TARTRATE	3.5MG	TABLET / SUBLINGUAL	AB	RS	2015-06-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204299-001	ZOLPIDEM TARTRATE	1.75MG	TABLET / SUBLINGUAL	AB		2015-06-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204299-002	ZOLPIDEM TARTRATE	3.5MG	TABLET / SUBLINGUAL	AB	RS	2015-06-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204299-001	ZOLPIDEM TARTRATE	1.75MG	TABLET / SUBLINGUAL	AB		2015-06-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204299-002	ZOLPIDEM TARTRATE	3.5MG	TABLET / SUBLINGUAL	AB	RS	2015-06-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204299-001	ZOLPIDEM TARTRATE	1.75MG	TABLET / SUBLINGUAL	AB		2015-06-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204299-002	ZOLPIDEM TARTRATE	3.5MG	TABLET / SUBLINGUAL	AB	RS	2015-06-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204299-001	ZOLPIDEM TARTRATE	1.75MG	TABLET / SUBLINGUAL	AB		2015-06-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204299-002	ZOLPIDEM TARTRATE	3.5MG	TABLET / SUBLINGUAL	AB	RS	2015-06-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204299-001	ZOLPIDEM TARTRATE	1.75MG	TABLET / SUBLINGUAL	AB		2015-06-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204299-002	ZOLPIDEM TARTRATE	3.5MG	TABLET / SUBLINGUAL	AB	RS	2015-06-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204299-001	ZOLPIDEM TARTRATE	1.75MG	TABLET / SUBLINGUAL	AB		2015-06-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204299-002	ZOLPIDEM TARTRATE	3.5MG	TABLET / SUBLINGUAL	AB	RS	2015-06-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204299-001	ZOLPIDEM TARTRATE	1.75MG	TABLET / SUBLINGUAL	AB		2015-06-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204299-002	ZOLPIDEM TARTRATE	3.5MG	TABLET / SUBLINGUAL	AB	RS	2015-06-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204299-001	ZOLPIDEM TARTRATE	1.75MG	TABLET / SUBLINGUAL	AB		2015-06-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204299-002	ZOLPIDEM TARTRATE	3.5MG	TABLET / SUBLINGUAL	AB	RS	2015-06-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204299-001	ZOLPIDEM TARTRATE	1.75MG	TABLET / SUBLINGUAL	AB		2015-06-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204299-002	ZOLPIDEM TARTRATE	3.5MG	TABLET / SUBLINGUAL	AB	RS	2015-06-03	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204299-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204299-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204299-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204299-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204299-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204299-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204299-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204299-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204299-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204299-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204299-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204299-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204299-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204299-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204299-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204299-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204299-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204299-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204299-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204299-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204299-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204299-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204299-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204299-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204299-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204299-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204299-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204299-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204299-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204299-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204299-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204299-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204299-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204299-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204299-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204299-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204299-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204299-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204299-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204299-002	AB	1	`782e0a99824c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
75543837-e611-4401-8337-81e7d5cb9b04	Product name	1	20231011
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
f40c5cae-52e4-45d3-95e3-8ba7f79e50e4	Product name	3	20201208
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
70793b8c-c4d9-ddb4-5f8a-4308eb0087a2	Product name	4	20171109
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
3970acdc-9e18-4f3d-165e-245802aafc57	Product name	2	20160829
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
438b1497-0992-6caa-062f-3853a7f9e4b1	Product name	1	20140508
813c8976-a1f1-3a35-1a71-1557bfb59446	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
40032-762-30	2023-01-30	C162847	48780-1	f386c649-a716-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use ZOLPIDEM TARTRATE safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE. ZOLPIDEM TARTRATE (zolpidem tartrate) TABLET for SUBLINGUAL use. Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
40032-762-01	ZOLPIDEM TARTRATE	1 in 1 POUCH	TABLET	1	6
40032-762-01	ZOLPIDEM TARTRATE	1 in 1 BLISTER PACK	TABLET	1	6
40032-762-30	ZOLPIDEM TARTRATE	30 in 1 CARTON	TABLET	30	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
40032-762	ZOLPIDEM TARTRATE TABLET [NOVEL LABORATORIES, INC.]	6	Legacy NDC, 3 package rows	20191221_0621151f-90c7-4915-bfd8-26e8447b10bd.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Lupin Pharmaceuticals,Inc.	6db679f6-b1f8-4fbf-9e87-9cef4650c45a	2020-11-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204299 application number: ANDA204299

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WY6W63843K	ZOLPIDEM TARTRATE	99294-93-6	ZOLPIDEM TARTRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1232194	zolpidem tartrate 1.75 MG Sublingual Tablet	PSN	0621151f-90c7-4915-bfd8-26e8447b10bd	6
1232202	zolpidem tartrate 3.5 MG Sublingual Tablet	PSN	0621151f-90c7-4915-bfd8-26e8447b10bd	6
1232194	zolpidem tartrate 1.75 MG Sublingual Tablet	SCD	0621151f-90c7-4915-bfd8-26e8447b10bd	6
1232202	zolpidem tartrate 3.5 MG Sublingual Tablet	SCD	0621151f-90c7-4915-bfd8-26e8447b10bd	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
40032-762-01	40032076201	1 in 1 POUCH						Historical
40032-762-30	40032076230	30 POUCH in 1 CARTON (40032-762-30) > 1 BLISTER PACK in 1 POUCH (40032-762-01) > 1 TABLET in 1 BLISTER PACK	30 pouch	2016-03-22	0000-00-00	No	No	Current