Zolpidem Tartrate

Product NDC: 0781-5317
11-digit product format: 007815317
Labeler code: 0781
Product ID: 0781-5317_d01ebe6c-e538-4039-8af6-cadae62f6989
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Zolpidem Tartrate
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Sandoz Inc
Application: ANDA077322
Marketing category: ANDA
Marketing start: 2007-04-23
Substance: ZOLPIDEM TARTRATE
Active strength: 5 mg/1
Pharmacologic classes: Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]
DEA schedule: CIV
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 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
A077322-001	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB		2007-04-23
A077322-002	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB		2007-04-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077322-001	AB
A077322-002	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077322-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077322-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077322-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077322-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077322-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077322-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077322-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077322-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077322-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077322-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077322-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077322-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077322-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077322-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077322-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077322-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077322-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077322-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077322-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077322-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077322-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077322-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077322-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077322-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077322-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077322-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077322-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077322-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077322-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077322-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077322-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077322-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077322-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077322-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077322-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077322-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077322-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077322-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077322-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077322-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`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	A077322-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077322-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077322-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077322-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077322-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077322-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077322-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077322-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077322-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077322-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077322-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077322-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077322-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077322-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077322-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077322-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077322-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077322-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077322-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077322-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077322-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077322-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077322-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077322-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077322-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077322-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077322-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077322-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077322-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077322-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077322-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077322-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077322-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077322-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077322-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077322-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077322-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077322-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077322-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077322-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Zolpidem Tartrate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZOLPIDEM TARTRATE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WY6W63843K	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
854873	Internal RxNorm lookup
854876	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
0553e26c-f2aa-43aa-adf9-6eb951a501d3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
75543837-e611-4401-8337-81e7d5cb9b04	Product name	1	20231011
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0781-5317-01	Zolpidem Tartrate	100 in 1 BOTTLE	TABLET, COATED	100	21
0781-5317-05	Zolpidem Tartrate	500 in 1 BOTTLE	TABLET, COATED	500	21
0781-5317-10	Zolpidem Tartrate	1000 in 1 BOTTLE	TABLET, COATED	1000	21
0781-5317-31	Zolpidem Tartrate	30 in 1 BOTTLE	TABLET, COATED	30	21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-5317-01	EA - Each	0781-5317	aa354f9a-fc19-48b0-98fb-46bac3e778fd	1	2013-02-13
0781-5317-10	EA - Each	0781-5317	d1d46e8a-65cb-4d2f-9b10-4ac20b31b5fe	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZOLPIDEM TARTRATE	ACTIVE INGREDIENT	WY6W63843K	ZOLPIDEM TARTRATE TABLET, COATED [SANDOZ INC]	14
ZOLPIDEM	ACTIVE MOIETY	7K383OQI23	ZOLPIDEM TARTRATE TABLET, COATED [SANDOZ INC]	14
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	ZOLPIDEM TARTRATE TABLET, COATED [SANDOZ INC]	14
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZOLPIDEM TARTRATE TABLET, COATED [SANDOZ INC]	14
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ZOLPIDEM TARTRATE TABLET, COATED [SANDOZ INC]	14
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	ZOLPIDEM TARTRATE TABLET, COATED [SANDOZ INC]	14
HYPROMELLOSE 2910 (15 MPA.S)	INACTIVE INGREDIENT	36SFW2JZ0W	ZOLPIDEM TARTRATE TABLET, COATED [SANDOZ INC]	14
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ZOLPIDEM TARTRATE TABLET, COATED [SANDOZ INC]	14
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ZOLPIDEM TARTRATE TABLET, COATED [SANDOZ INC]	14
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	ZOLPIDEM TARTRATE TABLET, COATED [SANDOZ INC]	14
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ZOLPIDEM TARTRATE TABLET, COATED [SANDOZ INC]	14
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ZOLPIDEM TARTRATE TABLET, COATED [SANDOZ INC]	14
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ZOLPIDEM TARTRATE TABLET, COATED [SANDOZ INC]	14
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ZOLPIDEM TARTRATE TABLET, COATED [SANDOZ INC]	14
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZOLPIDEM TARTRATE TABLET, COATED [SANDOZ INC]	14
ZOLPIDEM TARTRATE	ACTIVE INGREDIENT	WY6W63843K	ZOLPIDEM TARTRATE TABLET, COATED [AMERICAN HEALTH PACKAGING]	3
ZOLPIDEM	ACTIVE MOIETY	7K383OQI23	ZOLPIDEM TARTRATE TABLET, COATED [AMERICAN HEALTH PACKAGING]	3
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	ZOLPIDEM TARTRATE TABLET, COATED [AMERICAN HEALTH PACKAGING]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZOLPIDEM TARTRATE TABLET, COATED [AMERICAN HEALTH PACKAGING]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ZOLPIDEM TARTRATE TABLET, COATED [AMERICAN HEALTH PACKAGING]	3
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	ZOLPIDEM TARTRATE TABLET, COATED [AMERICAN HEALTH PACKAGING]	3
HYPROMELLOSE 2910 (15 MPA.S)	INACTIVE INGREDIENT	36SFW2JZ0W	ZOLPIDEM TARTRATE TABLET, COATED [AMERICAN HEALTH PACKAGING]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ZOLPIDEM TARTRATE TABLET, COATED [AMERICAN HEALTH PACKAGING]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ZOLPIDEM TARTRATE TABLET, COATED [AMERICAN HEALTH PACKAGING]	3
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	ZOLPIDEM TARTRATE TABLET, COATED [AMERICAN HEALTH PACKAGING]	3
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ZOLPIDEM TARTRATE TABLET, COATED [AMERICAN HEALTH PACKAGING]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ZOLPIDEM TARTRATE TABLET, COATED [AMERICAN HEALTH PACKAGING]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ZOLPIDEM TARTRATE TABLET, COATED [AMERICAN HEALTH PACKAGING]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ZOLPIDEM TARTRATE TABLET, COATED [AMERICAN HEALTH PACKAGING]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZOLPIDEM TARTRATE TABLET, COATED [AMERICAN HEALTH PACKAGING]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0781-5317	ZOLPIDEM TARTRATE TABLET, COATED [SANDOZ INC]	21	Current NDC, Legacy NDC, 4 package rows	20250228_0553e26c-f2aa-43aa-adf9-6eb951a501d3.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zolpidem Tartrate	ZOLPIDEM TARTRATE	REMEDYREPACK INC.	0f8488f3-851d-4111-af23-60f420aad0d6	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077322 application number: ANDA077322
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Northwind Health Company, LLC	47212207-52a1-938b-e063-6294a90abca8	2025-12-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077322 application number: ANDA077322
Zolpidem Tartrate	ZOLPIDEM TARTRATE	ST. MARY'S MEDICAL PARK PHARMACY	3bc8a122-aa21-212c-e063-6394a90a3bda	2025-08-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077322 application number: ANDA077322
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Proficient Rx LP	92c58053-7ed8-4a3d-a2f7-8e30c4e5a367	2025-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077322 application number: ANDA077322
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Advanced Rx of Tennessee, LLC	3310d63e-d79a-175d-e063-6394a90a4270	2025-04-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077322 application number: ANDA077322
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Preferred Pharmaceuticals Inc.	d579c6ca-c820-49ff-92fb-2e6aaad3b052	2025-04-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077322 application number: ANDA077322
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Advanced Rx of Tennessee, LLC	af87b722-cdb7-0b17-e053-2a95a90a315b	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077322 application number: ANDA077322
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Sandoz Inc	0553e26c-f2aa-43aa-adf9-6eb951a501d3	2024-09-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077322 application number: ANDA077322 ndc (product): 0781-5317
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	f9c108d1-5e2f-41c7-a845-2aed48c30905	2024-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077322 application number: ANDA077322

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
854876	zolpidem tartrate 5 MG Oral Tablet	PSN	f9c108d1-5e2f-41c7-a845-2aed48c30905	102
854876	zolpidem tartrate 5 MG Oral Tablet	SCD	f9c108d1-5e2f-41c7-a845-2aed48c30905	102
854873	zolpidem tartrate 10 MG Oral Tablet	PSN	0553e26c-f2aa-43aa-adf9-6eb951a501d3	21
854876	zolpidem tartrate 5 MG Oral Tablet	PSN	0553e26c-f2aa-43aa-adf9-6eb951a501d3	21
854873	zolpidem tartrate 10 MG Oral Tablet	SCD	0553e26c-f2aa-43aa-adf9-6eb951a501d3	21
854876	zolpidem tartrate 5 MG Oral Tablet	SCD	0553e26c-f2aa-43aa-adf9-6eb951a501d3	21
854873	zolpidem tartrate 10 MG Oral Tablet	PSN	92c58053-7ed8-4a3d-a2f7-8e30c4e5a367	4
854876	zolpidem tartrate 5 MG Oral Tablet	PSN	92c58053-7ed8-4a3d-a2f7-8e30c4e5a367	4
854873	zolpidem tartrate 10 MG Oral Tablet	SCD	92c58053-7ed8-4a3d-a2f7-8e30c4e5a367	4
854876	zolpidem tartrate 5 MG Oral Tablet	SCD	92c58053-7ed8-4a3d-a2f7-8e30c4e5a367	4
854876	zolpidem tartrate 5 MG Oral Tablet	PSN	3310d63e-d79a-175d-e063-6394a90a4270	1
854876	zolpidem tartrate 5 MG Oral Tablet	PSN	3bc8a122-aa21-212c-e063-6394a90a3bda	1
854876	zolpidem tartrate 5 MG Oral Tablet	PSN	d579c6ca-c820-49ff-92fb-2e6aaad3b052	1
854876	zolpidem tartrate 5 MG Oral Tablet	SCD	3310d63e-d79a-175d-e063-6394a90a4270	1
854876	zolpidem tartrate 5 MG Oral Tablet	SCD	3bc8a122-aa21-212c-e063-6394a90a3bda	1
854876	zolpidem tartrate 5 MG Oral Tablet	SCD	d579c6ca-c820-49ff-92fb-2e6aaad3b052	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-5317-01	00781531701	100 TABLET, COATED in 1 BOTTLE (0781-5317-01)	2007-04-23	0000-00-00	No	No	Current
0781-5317-05	00781531705	500 TABLET, COATED in 1 BOTTLE (0781-5317-05)	2007-04-23	0000-00-00	No	No	Current
0781-5317-10	00781531710	1000 TABLET, COATED in 1 BOTTLE (0781-5317-10)	2007-04-23	0000-00-00	No	No	Current
0781-5317-31	00781531731	30 TABLET, COATED in 1 BOTTLE (0781-5317-31)	2007-04-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zolpidem Tartrate	ST. MARY'S MEDICAL PARK PHARMACY	2025-08-07	HUMAN PRESCRIPTION DRUG LABEL	1
Zolpidem Tartrate	Proficient Rx LP	2025-06-01	HUMAN PRESCRIPTION DRUG LABEL	4
Zolpidem Tartrate	Advanced Rx of Tennessee, LLC	2025-04-18	HUMAN PRESCRIPTION DRUG LABEL	1
Zolpidem Tartrate	Preferred Pharmaceuticals Inc.	2025-04-11	HUMAN PRESCRIPTION DRUG LABEL	1
Zolpidem Tartrate	Quality Care Products, LLC	2024-12-19	HUMAN PRESCRIPTION DRUG LABEL	4
Zolpidem Tartrate	American Health Packaging	2024-10-01	HUMAN PRESCRIPTION DRUG LABEL	10
Zolpidem Tartrate	Sandoz Inc	2024-09-10	HUMAN PRESCRIPTION DRUG LABEL	21
Zolpidem Tartrate	Bryant Ranch Prepack	2024-08-28	HUMAN PRESCRIPTION DRUG LABEL	102