Ambien

Product NDC: 0024-5421
Requested package NDC: 0024-5421-31
11-digit product format: 000245421
Labeler code: 0024
Product ID: 0024-5421_c8f05d12-bc35-43cb-8b65-588bec02c73d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: zolpidem tartrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: sanofi-aventis U.S. LLC
Application: NDA019908
Marketing category: NDA
Marketing start: 1993-04-01
Marketing end: 0000-00-00
Substance: ZOLPIDEM TARTRATE
Active strength: 10 mg/1
Pharmacologic classes: Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0024-5421	0024-5421-31	D	Discontinued by firm		2026-10-05

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
N019908-001	AMBIEN	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	RLD	1992-12-16
N019908-002	AMBIEN	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N019908-001	AB
N019908-002	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 · 86 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	N019908-001	AMBIEN	5MG	TABLET / ORAL	AB	RLD	1992-12-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019908-002	AMBIEN	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019908-001	AMBIEN	5MG	TABLET / ORAL	AB	RLD	1992-12-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019908-002	AMBIEN	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019908-001	AMBIEN	5MG	TABLET / ORAL	AB	RLD	1992-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019908-002	AMBIEN	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019908-001	AMBIEN	5MG	TABLET / ORAL	AB	RLD	1992-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019908-002	AMBIEN	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019908-001	AMBIEN	5MG	TABLET / ORAL	AB	RLD	1992-12-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019908-002	AMBIEN	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019908-001	AMBIEN	5MG	TABLET / ORAL	AB	RLD	1992-12-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019908-002	AMBIEN	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019908-001	AMBIEN	5MG	TABLET / ORAL	AB	RLD	1992-12-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019908-002	AMBIEN	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019908-001	AMBIEN	5MG	TABLET / ORAL	AB	RLD	1992-12-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019908-002	AMBIEN	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019908-001	AMBIEN	5MG	TABLET / ORAL	AB	RLD	1992-12-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019908-002	AMBIEN	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019908-001	AMBIEN	5MG	TABLET / ORAL	AB	RLD	1992-12-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019908-002	AMBIEN	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019908-001	AMBIEN	5MG	TABLET / ORAL	AB	RLD	1992-12-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019908-002	AMBIEN	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019908-001	AMBIEN	5MG	TABLET / ORAL	AB	RLD	1992-12-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019908-002	AMBIEN	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019908-001	AMBIEN	5MG	TABLET / ORAL	AB	RLD	1992-12-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019908-002	AMBIEN	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019908-001	AMBIEN	5MG	TABLET / ORAL	AB	RLD	1992-12-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019908-002	AMBIEN	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019908-001	AMBIEN	5MG	TABLET / ORAL	AB	RLD	1992-12-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019908-002	AMBIEN	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019908-001	AMBIEN	5MG	TABLET / ORAL	AB	RLD	1992-12-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019908-002	AMBIEN	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019908-001	AMBIEN	5MG	TABLET / ORAL	AB	RLD	1992-12-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019908-002	AMBIEN	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019908-001	AMBIEN	5MG	TABLET / ORAL	AB	RLD	1992-12-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019908-002	AMBIEN	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019908-001	AMBIEN	5MG	TABLET / ORAL	AB	RLD	1992-12-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019908-002	AMBIEN	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019908-001	AMBIEN	5MG	TABLET / ORAL	AB	RLD	1992-12-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019908-002	AMBIEN	10MG	TABLET / ORAL	AB	RLD, RS	1992-12-16	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N019908-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019908-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019908-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019908-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019908-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019908-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019908-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019908-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019908-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019908-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019908-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019908-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019908-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019908-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019908-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019908-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019908-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019908-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019908-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019908-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019908-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019908-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019908-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019908-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019908-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019908-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019908-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019908-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019908-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019908-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019908-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019908-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019908-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019908-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019908-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019908-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019908-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019908-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019908-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019908-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
75543837-e611-4401-8337-81e7d5cb9b04	Product name	1	20231011
f40c5cae-52e4-45d3-95e3-8ba7f79e50e4	Product name	3	20201208
70793b8c-c4d9-ddb4-5f8a-4308eb0087a2	Product name	4	20171109
3970acdc-9e18-4f3d-165e-245802aafc57	Product name	2	20160829
438b1497-0992-6caa-062f-3853a7f9e4b1	Product name	1	20140508
813c8976-a1f1-3a35-1a71-1557bfb59446	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0024-5421-31	2024-08-20	These highlights do not include all the information needed to use AMBIEN safely and effectively. See full prescribing information for AMBIEN. AMBIEN ® (zolpidem tartrate) tablets, for oral use, C-IV Initial U.S. Approval: 1992
0024-5421-50	2024-08-20	These highlights do not include all the information needed to use AMBIEN safely and effectively. See full prescribing information for AMBIEN. AMBIEN ® (zolpidem tartrate) tablets, for oral use, C-IV Initial U.S. Approval: 1992
0024-5421-31	2024-07-30	These highlights do not include all the information needed to use AMBIEN safely and effectively. See full prescribing information for AMBIEN. AMBIEN ® (zolpidem tartrate) tablets, for oral use, C-IV Initial U.S. Approval: 1992
0024-5421-50	2024-07-30	These highlights do not include all the information needed to use AMBIEN safely and effectively. See full prescribing information for AMBIEN. AMBIEN ® (zolpidem tartrate) tablets, for oral use, C-IV Initial U.S. Approval: 1992
0024-5421-31	2024-01-30	These highlights do not include all the information needed to use AMBIEN safely and effectively. See full prescribing information for AMBIEN. AMBIEN ® (zolpidem tartrate) tablets, for oral use, C-IV Initial U.S. Approval: 1992
0024-5421-50	2024-01-30	These highlights do not include all the information needed to use AMBIEN safely and effectively. See full prescribing information for AMBIEN. AMBIEN ® (zolpidem tartrate) tablets, for oral use, C-IV Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0024-5421-31	Ambien	100 in 1 BOTTLE	TABLET, FILM COATED	100		26
0024-5421-50	Ambien	500 in 1 BOTTLE	TABLET, FILM COATED	500		26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0024-5421-31	EA - Each	0024-5421	33678ada-0934-4caa-ae2d-ba7b74ba675f	1	2012-07-24
0024-5421-50	EA - Each	0024-5421	e9fc0ab5-ff9b-485a-9113-6f3e930c7f16	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
zolpidem tartrate	ACTIVE INGREDIENT	WY6W63843K	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	10
zolpidem	ACTIVE MOIETY	7K383OQI23	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	10
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	10
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	10
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	10
lactose	INACTIVE INGREDIENT	J2B2A4N98G	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	10
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	10
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	10
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	10
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	10
ZOLPIDEM TARTRATE	ACTIVE INGREDIENT	WY6W63843K	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [STAT RX USA LLC]	3
ZOLPIDEM	ACTIVE MOIETY	7K383OQI23	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [STAT RX USA LLC]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [STAT RX USA LLC]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [STAT RX USA LLC]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [STAT RX USA LLC]	3
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [STAT RX USA LLC]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [STAT RX USA LLC]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [STAT RX USA LLC]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [STAT RX USA LLC]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [STAT RX USA LLC]	3
zolpidem tartrate	ACTIVE INGREDIENT	WY6W63843K	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
zolpidem	ACTIVE MOIETY	7K383OQI23	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
hypromellose	INACTIVE INGREDIENT	3NXW29V3WO	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
lactose	INACTIVE INGREDIENT	J2B2A4N98G	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
polyethylene glycol	INACTIVE INGREDIENT	3WJQ0SDW1A	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0024-5421	AMBIEN (ZOLPIDEM TARTRATE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	26	Legacy NDC, 2 package rows	20250418_c36cadf4-65a4-4466-b409-c82020b42452.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
Ambien	ZOLPIDEM TARTRATE	Sanofi-Aventis U.S. LLC	c36cadf4-65a4-4466-b409-c82020b42452	2025-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019908 application number: NDA019908 ndc (package): 0024-5421-31 ndc (product): 0024-5421 ndc11 (package): 00024542131
Ambien	ZOLPIDEM TARTRATE	Cosette Pharmaceuticals, Inc.	747949c5-2c91-4909-8a07-71b6826f8e97	2025-02-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019908 application number: NDA019908

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
854875	AMBIEN 10 MG Oral Tablet	PSN	c36cadf4-65a4-4466-b409-c82020b42452	26
854878	AMBIEN 5 MG Oral Tablet	PSN	c36cadf4-65a4-4466-b409-c82020b42452	26
854873	zolpidem tartrate 10 MG Oral Tablet	PSN	c36cadf4-65a4-4466-b409-c82020b42452	26
854876	zolpidem tartrate 5 MG Oral Tablet	PSN	c36cadf4-65a4-4466-b409-c82020b42452	26
854875	zolpidem tartrate 10 MG Oral Tablet [Ambien]	SBD	c36cadf4-65a4-4466-b409-c82020b42452	26
854878	zolpidem tartrate 5 MG Oral Tablet [Ambien]	SBD	c36cadf4-65a4-4466-b409-c82020b42452	26
854873	zolpidem tartrate 10 MG Oral Tablet	SCD	c36cadf4-65a4-4466-b409-c82020b42452	26
854876	zolpidem tartrate 5 MG Oral Tablet	SCD	c36cadf4-65a4-4466-b409-c82020b42452	26
854875	Ambien 10 MG Oral Tablet	SY	c36cadf4-65a4-4466-b409-c82020b42452	26
854878	Ambien 5 MG Oral Tablet	SY	c36cadf4-65a4-4466-b409-c82020b42452	26
854875	AMBIEN 10 MG Oral Tablet	PSN	02b5e3bb-c976-40a3-9077-64ffe637429f	3
854878	AMBIEN 5 MG Oral Tablet	PSN	02b5e3bb-c976-40a3-9077-64ffe637429f	3
854873	zolpidem tartrate 10 MG Oral Tablet	PSN	02b5e3bb-c976-40a3-9077-64ffe637429f	3
854876	zolpidem tartrate 5 MG Oral Tablet	PSN	02b5e3bb-c976-40a3-9077-64ffe637429f	3
854875	zolpidem tartrate 10 MG Oral Tablet [Ambien]	SBD	02b5e3bb-c976-40a3-9077-64ffe637429f	3
854878	zolpidem tartrate 5 MG Oral Tablet [Ambien]	SBD	02b5e3bb-c976-40a3-9077-64ffe637429f	3
854873	zolpidem tartrate 10 MG Oral Tablet	SCD	02b5e3bb-c976-40a3-9077-64ffe637429f	3
854876	zolpidem tartrate 5 MG Oral Tablet	SCD	02b5e3bb-c976-40a3-9077-64ffe637429f	3
854875	Ambien 10 MG Oral Tablet	SY	02b5e3bb-c976-40a3-9077-64ffe637429f	3
854878	Ambien 5 MG Oral Tablet	SY	02b5e3bb-c976-40a3-9077-64ffe637429f	3
854875	AMBIEN 10 MG Oral Tablet	PSN	9dea009e-d435-4268-ab25-cf48a6c69abb	1
854878	AMBIEN 5 MG Oral Tablet	PSN	9dea009e-d435-4268-ab25-cf48a6c69abb	1
854873	zolpidem tartrate 10 MG Oral Tablet	PSN	9dea009e-d435-4268-ab25-cf48a6c69abb	1
854876	zolpidem tartrate 5 MG Oral Tablet	PSN	9dea009e-d435-4268-ab25-cf48a6c69abb	1
854875	zolpidem tartrate 10 MG Oral Tablet [Ambien]	SBD	9dea009e-d435-4268-ab25-cf48a6c69abb	1
854878	zolpidem tartrate 5 MG Oral Tablet [Ambien]	SBD	9dea009e-d435-4268-ab25-cf48a6c69abb	1
854873	zolpidem tartrate 10 MG Oral Tablet	SCD	9dea009e-d435-4268-ab25-cf48a6c69abb	1
854876	zolpidem tartrate 5 MG Oral Tablet	SCD	9dea009e-d435-4268-ab25-cf48a6c69abb	1
854875	Ambien 10 MG Oral Tablet	SY	9dea009e-d435-4268-ab25-cf48a6c69abb	1
854878	Ambien 5 MG Oral Tablet	SY	9dea009e-d435-4268-ab25-cf48a6c69abb	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0024-5421-31	00024542131	100 TABLET, FILM COATED in 1 BOTTLE (0024-5421-31)	1993-04-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ambien	Sanofi-Aventis U.S. LLC \| Sanofi Winthrop Industrie \| Finorga	2025-04-15	HUMAN PRESCRIPTION DRUG LABEL	26
AMBIEN	STAT Rx USA LLC \| PSS World Medical Inc.	2012-09-18	HUMAN PRESCRIPTION DRUG LABEL	3
Ambien	Rebel Distributors Corp.	2009-07-01	HUMAN PRESCRIPTION DRUG LABEL	1