ZOLPIDEM TARTRATE

Product NDC: 13668-008
11-digit product format: 136680008
Labeler code: 13668
Product ID: 13668-008_783b6c2c-bec3-44db-b758-d762377a34ba
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: zolpidem tartrate
Dosage form: TABLET
Route: ORAL
Labeler: Torrent Pharmaceuticals Limited
Application: ANDA077903
Marketing category: ANDA
Marketing start: 2007-09-05
Substance: ZOLPIDEM TARTRATE
Active strength: 10 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
A077903-001	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB		2007-08-17
A077903-002	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB		2007-08-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077903-001	AB
A077903-002	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	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077903-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-08-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077903-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-08-17	`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	A077903-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077903-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077903-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077903-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077903-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077903-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077903-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077903-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077903-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077903-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077903-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077903-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077903-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077903-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077903-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077903-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077903-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077903-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077903-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077903-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077903-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077903-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077903-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077903-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077903-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077903-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077903-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077903-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077903-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077903-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077903-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077903-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077903-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077903-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077903-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077903-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077903-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077903-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077903-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077903-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: ZOLPIDEM TARTRATE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZOLPIDEM TARTRATE	10 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
1584bad1-7bf4-4805-bdd9-7eb0fac92721	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
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
13668-008-01	ZOLPIDEM TARTRATE	100 in 1 BOTTLE	TABLET	100	24
13668-008-05	ZOLPIDEM TARTRATE	500 in 1 BOTTLE	TABLET	500	24
13668-008-10	ZOLPIDEM TARTRATE	1000 in 1 BOTTLE	TABLET	1000	24
13668-008-15	ZOLPIDEM TARTRATE	1500 in 1 BOTTLE	TABLET	1500	24
13668-008-30	ZOLPIDEM TARTRATE	30 in 1 BOTTLE	TABLET	30	24
13668-008-90	ZOLPIDEM TARTRATE	90 in 1 BOTTLE	TABLET	90	24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13668-008-01	EA - Each	13668-008	408b28ce-9f95-4a89-a933-5cc463c8d510	1	2012-07-24
13668-008-05	EA - Each	13668-008	b5029160-e8d6-46a2-a09c-1a9190a6ef63	1	2012-07-24
13668-008-10	EA - Each	13668-008	4d7f6028-463c-4ba1-af18-5d1e6341ec26	1	2012-07-24
13668-008-15	EA - Each	13668-008	80733af8-8a6d-4b0c-8038-7c85a5ecee7f	1	2012-07-24
13668-008-30	EA - Each	13668-008	9adf4d70-b1a1-4714-a7f1-658515074063	1	2012-07-24
13668-008-74	EA - Each	13668-008	4099426f-51bf-4a51-b96a-7703fb17132e	1	2012-07-24
13668-008-90	EA - Each	13668-008	7628ad12-220f-451b-95df-1dfa8c3b0b36	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZOLPIDEM TARTRATE	ACTIVE INGREDIENT	WY6W63843K	ZOLPIDEM TARTRATE TABLET [PD-RX PHARMACEUTICALS, INC.]	10
ZOLPIDEM	ACTIVE MOIETY	7K383OQI23	ZOLPIDEM TARTRATE TABLET [PD-RX PHARMACEUTICALS, INC.]	10
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ZOLPIDEM TARTRATE TABLET [PD-RX PHARMACEUTICALS, INC.]	10
ZOLPIDEM TARTRATE	ACTIVE INGREDIENT	WY6W63843K	ZOLPIDEM TARTRATE TABLET [MAJOR PHARMACEUTICALS]	9
ZOLPIDEM TARTRATE	ACTIVE INGREDIENT	WY6W63843K	ZOLPIDEM TARTRATE TABLET [TORRENT PHARMACEUTICALS LIMITED]	9
ZOLPIDEM	ACTIVE MOIETY	7K383OQI23	ZOLPIDEM TARTRATE TABLET [MAJOR PHARMACEUTICALS]	9
ZOLPIDEM	ACTIVE MOIETY	7K383OQI23	ZOLPIDEM TARTRATE TABLET [TORRENT PHARMACEUTICALS LIMITED]	9
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ZOLPIDEM TARTRATE TABLET [MAJOR PHARMACEUTICALS]	9
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ZOLPIDEM TARTRATE TABLET [TORRENT PHARMACEUTICALS LIMITED]	9
ZOLPIDEM TARTRATE	ACTIVE INGREDIENT	WY6W63843K	ZOLPIDEM TARTRATE TABLET [PREFERRED PHARMACEUTICALS, INC.]	3
ZOLPIDEM TARTRATE	ACTIVE INGREDIENT	WY6W63843K	ZOLPIDEM TARTRATE TABLET [MEDSOURCE PHARMACEUTICALS]	3
ZOLPIDEM	ACTIVE MOIETY	7K383OQI23	ZOLPIDEM TARTRATE TABLET [MEDSOURCE PHARMACEUTICALS]	3
ZOLPIDEM	ACTIVE MOIETY	7K383OQI23	ZOLPIDEM TARTRATE TABLET [PREFERRED PHARMACEUTICALS, INC.]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ZOLPIDEM TARTRATE TABLET [MEDSOURCE PHARMACEUTICALS]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ZOLPIDEM TARTRATE TABLET [PREFERRED PHARMACEUTICALS, INC.]	3
ZOLPIDEM TARTRATE	ACTIVE INGREDIENT	WY6W63843K	ZOLPIDEM TARTRATE TABLET [TYA PHARMACEUTICALS]	2
ZOLPIDEM TARTRATE	ACTIVE INGREDIENT	WY6W63843K	ZOLPIDEM TARTRATE TABLET [STAT RX USA LLC]	2
ZOLPIDEM	ACTIVE MOIETY	7K383OQI23	ZOLPIDEM TARTRATE TABLET [STAT RX USA LLC]	2
ZOLPIDEM	ACTIVE MOIETY	7K383OQI23	ZOLPIDEM TARTRATE TABLET [TYA PHARMACEUTICALS]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZOLPIDEM TARTRATE TABLET [STAT RX USA LLC]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ZOLPIDEM TARTRATE TABLET [TYA PHARMACEUTICALS]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ZOLPIDEM TARTRATE TABLET [STAT RX USA LLC]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ZOLPIDEM TARTRATE TABLET [STAT RX USA LLC]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ZOLPIDEM TARTRATE TABLET [STAT RX USA LLC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ZOLPIDEM TARTRATE TABLET [STAT RX USA LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ZOLPIDEM TARTRATE TABLET [STAT RX USA LLC]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ZOLPIDEM TARTRATE TABLET [STAT RX USA LLC]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ZOLPIDEM TARTRATE TABLET [STAT RX USA LLC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZOLPIDEM TARTRATE TABLET [STAT RX USA LLC]	2
ZOLPIDEM TARTRATE	ACTIVE INGREDIENT	WY6W63843K	ZOLPIDEM TARTRATE TABLET [H.J. HARKINS COMPANY, INC.]	1
ZOLPIDEM TARTRATE	ACTIVE INGREDIENT	WY6W63843K	ZOLPIDEM TARTRATE TABLET [REBEL DISTRIBUTORS CORP.]	1
ZOLPIDEM TARTRATE	ACTIVE INGREDIENT	WY6W63843K	ZOLPIDEM TARTRATE TABLET [PROFICIENT RX LP]	1
ZOLPIDEM TARTRATE	ACTIVE INGREDIENT	WY6W63843K	ZOLPIDEM TARTRATE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
ZOLPIDEM	ACTIVE MOIETY	7K383OQI23	ZOLPIDEM TARTRATE TABLET [PROFICIENT RX LP]	1
ZOLPIDEM	ACTIVE MOIETY	7K383OQI23	ZOLPIDEM TARTRATE TABLET [H.J. HARKINS COMPANY, INC.]	1
ZOLPIDEM	ACTIVE MOIETY	7K383OQI23	ZOLPIDEM TARTRATE TABLET [REBEL DISTRIBUTORS CORP.]	1
ZOLPIDEM	ACTIVE MOIETY	7K383OQI23	ZOLPIDEM TARTRATE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ZOLPIDEM TARTRATE TABLET [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13668-008	ZOLPIDEM TARTRATE TABLET [TORRENT PHARMACEUTICALS LIMITED]	24	Current NDC, Legacy NDC, 6 package rows	20240808_1584bad1-7bf4-4805-bdd9-7eb0fac92721.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 2 · 29 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	St. Mary's Medical Park Pharmacy	507225e2-80ba-18c4-e054-00144ff88e88	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Torrent Pharmaceuticals Limited	1584bad1-7bf4-4805-bdd9-7eb0fac92721	2026-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903 ndc (product): 13668-008
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	St. Mary's Medical Park Pharmacy	89cfb1d5-437c-4c13-8f9b-b6851ffba87b	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	REMEDYREPACK INC.	2abdcf77-d3ed-42bc-acd9-545aab75d567	2026-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Calvin Scott & Co., Inc.	7da75d2b-905c-4fdf-bc53-1358c6477755	2026-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	A-S Medication Solutions	59cc61da-838e-4add-b2d6-42b2b283a000	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Direct_Rx	907c7b18-2638-512c-e053-2995a90ae6fd	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Northwind Health Company, LLC	26e20f53-c042-eac0-e063-6394a90acfca	2025-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Cardinal Health 107, LLC	83510333-f07d-4b81-a3ae-2801d114bd31	2025-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Preferred Pharmaceuticals, Inc.	a9ac3d4e-f502-41e3-95c0-0d334584566d	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Major Pharmaceuticals	d34336b1-7041-4078-beda-94bc9d9f771e	2025-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Asclemed USA, Inc.	e5e2d31b-ce26-78b0-e053-2a95a90ac491	2025-02-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Advanced Rx of Tennessee, LLC	af87ae17-a3c5-a3a5-e053-2a95a90aa4b0	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Advanced Rx Pharmacy of Tennessee, LLC	c8adec28-9dcd-4a7e-e053-2a95a90a991e	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Advanced Rx Pharmacy of Tennessee, LLC	fc76ab4c-3607-39c3-e053-6394a90a6877	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
Zolpidem Tartrate	ZOLPIDEM TARTRATE	Advanced Rx Pharmacy of Tennessee, LLC	f939549f-14a6-d37c-e053-6294a90a034a	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Lake Erie Medical DBA Quality Care Products LLC	db735db9-1c82-4d32-bf91-97b05a75e876	2024-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	NuCare Pharmaceuticals,Inc.	95b0ba48-4e71-25f7-e053-2a95a90aea82	2024-10-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	413b6f65-101e-e2cf-0802-711d080b851b	2024-08-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	3bbc3c35-2811-4a67-9dcc-5eed38ef8b52	2024-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077903 application number: ANDA077903

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
854873	zolpidem tartrate 10 MG Oral Tablet	PSN	1584bad1-7bf4-4805-bdd9-7eb0fac92721	24
854876	zolpidem tartrate 5 MG Oral Tablet	PSN	1584bad1-7bf4-4805-bdd9-7eb0fac92721	24
854873	zolpidem tartrate 10 MG Oral Tablet	SCD	1584bad1-7bf4-4805-bdd9-7eb0fac92721	24
854876	zolpidem tartrate 5 MG Oral Tablet	SCD	1584bad1-7bf4-4805-bdd9-7eb0fac92721	24
854873	zolpidem tartrate 10 MG Oral Tablet	PSN	d34336b1-7041-4078-beda-94bc9d9f771e	19
854876	zolpidem tartrate 5 MG Oral Tablet	PSN	d34336b1-7041-4078-beda-94bc9d9f771e	19
854873	zolpidem tartrate 10 MG Oral Tablet	SCD	d34336b1-7041-4078-beda-94bc9d9f771e	19
854876	zolpidem tartrate 5 MG Oral Tablet	SCD	d34336b1-7041-4078-beda-94bc9d9f771e	19
854873	zolpidem tartrate 10 MG Oral Tablet	PSN	3bbc3c35-2811-4a67-9dcc-5eed38ef8b52	15
854873	zolpidem tartrate 10 MG Oral Tablet	SCD	3bbc3c35-2811-4a67-9dcc-5eed38ef8b52	15
854873	zolpidem tartrate 10 MG Oral Tablet	PSN	db735db9-1c82-4d32-bf91-97b05a75e876	12
854873	zolpidem tartrate 10 MG Oral Tablet	PSN	a9ac3d4e-f502-41e3-95c0-0d334584566d	12
854876	zolpidem tartrate 5 MG Oral Tablet	PSN	a9ac3d4e-f502-41e3-95c0-0d334584566d	12
854873	zolpidem tartrate 10 MG Oral Tablet	SCD	db735db9-1c82-4d32-bf91-97b05a75e876	12
854873	zolpidem tartrate 10 MG Oral Tablet	SCD	a9ac3d4e-f502-41e3-95c0-0d334584566d	12
854876	zolpidem tartrate 5 MG Oral Tablet	SCD	a9ac3d4e-f502-41e3-95c0-0d334584566d	12
854873	zolpidem tartrate 10 MG Oral Tablet	PSN	1211fbc0-7b2a-4bd0-8be4-9fdcc0553aee	8
854876	zolpidem tartrate 5 MG Oral Tablet	PSN	1211fbc0-7b2a-4bd0-8be4-9fdcc0553aee	8
854873	zolpidem tartrate 10 MG Oral Tablet	SCD	1211fbc0-7b2a-4bd0-8be4-9fdcc0553aee	8
854876	zolpidem tartrate 5 MG Oral Tablet	SCD	1211fbc0-7b2a-4bd0-8be4-9fdcc0553aee	8
854873	zolpidem tartrate 10 MG Oral Tablet	PSN	507225e2-80ba-18c4-e054-00144ff88e88	7
854873	zolpidem tartrate 10 MG Oral Tablet	PSN	96d08f88-c841-46d6-958d-7f45656e672c	7
854873	zolpidem tartrate 10 MG Oral Tablet	PSN	af87ae17-a3c5-a3a5-e053-2a95a90aa4b0	7
854876	zolpidem tartrate 5 MG Oral Tablet	PSN	96d08f88-c841-46d6-958d-7f45656e672c	7
854873	zolpidem tartrate 10 MG Oral Tablet	SCD	af87ae17-a3c5-a3a5-e053-2a95a90aa4b0	7
854873	zolpidem tartrate 10 MG Oral Tablet	SCD	96d08f88-c841-46d6-958d-7f45656e672c	7
854873	zolpidem tartrate 10 MG Oral Tablet	SCD	507225e2-80ba-18c4-e054-00144ff88e88	7
854876	zolpidem tartrate 5 MG Oral Tablet	SCD	96d08f88-c841-46d6-958d-7f45656e672c	7
854873	zolpidem tartrate 10 MG Oral Tablet	PSN	4be6ce23-e7b1-510e-e054-00144ff8d46c	6
854873	zolpidem tartrate 10 MG Oral Tablet	SCD	4be6ce23-e7b1-510e-e054-00144ff8d46c	6
854873	zolpidem tartrate 10 MG Oral Tablet	PSN	eaca34da-2b12-4dd4-91b5-a8446c7bd41e	5
854873	zolpidem tartrate 10 MG Oral Tablet	PSN	95b0ba48-4e71-25f7-e053-2a95a90aea82	5
854873	zolpidem tartrate 10 MG Oral Tablet	SCD	eaca34da-2b12-4dd4-91b5-a8446c7bd41e	5
854873	zolpidem tartrate 10 MG Oral Tablet	SCD	95b0ba48-4e71-25f7-e053-2a95a90aea82	5
854873	zolpidem tartrate 10 MG Oral Tablet	PSN	25f1176d-5195-1a99-e054-00144ff8d46c	4
854873	zolpidem tartrate 10 MG Oral Tablet	SCD	25f1176d-5195-1a99-e054-00144ff8d46c	4
854873	zolpidem tartrate 10 MG Oral Tablet	PSN	92c6cc45-c28b-729b-e053-2a95a90a7ccb	3
854873	zolpidem tartrate 10 MG Oral Tablet	PSN	98e5208b-5109-58c6-e053-2995a90a994a	3
854873	zolpidem tartrate 10 MG Oral Tablet	PSN	1b66047b-4782-4808-e054-00144ff8d46c	3
854873	zolpidem tartrate 10 MG Oral Tablet	PSN	c0543e05-3220-4a8a-abd9-6a73c42848c2	3
854876	zolpidem tartrate 5 MG Oral Tablet	PSN	c0543e05-3220-4a8a-abd9-6a73c42848c2	3
854873	zolpidem tartrate 10 MG Oral Tablet	SCD	92c6cc45-c28b-729b-e053-2a95a90a7ccb	3
854873	zolpidem tartrate 10 MG Oral Tablet	SCD	c0543e05-3220-4a8a-abd9-6a73c42848c2	3
854873	zolpidem tartrate 10 MG Oral Tablet	SCD	98e5208b-5109-58c6-e053-2995a90a994a	3
854873	zolpidem tartrate 10 MG Oral Tablet	SCD	1b66047b-4782-4808-e054-00144ff8d46c	3
854876	zolpidem tartrate 5 MG Oral Tablet	SCD	c0543e05-3220-4a8a-abd9-6a73c42848c2	3
854873	zolpidem tartrate 10 MG Oral Tablet	PSN	b87ea23e-2d54-4d10-8f10-72d4c62f3245	2
854873	zolpidem tartrate 10 MG Oral Tablet	PSN	e5e2d31b-ce26-78b0-e053-2a95a90ac491	2
854873	zolpidem tartrate 10 MG Oral Tablet	PSN	fc76ab4c-3607-39c3-e053-6394a90a6877	2
854873	zolpidem tartrate 10 MG Oral Tablet	PSN	11934d96-36f4-4c32-b14a-a665c7400f3b	2
854873	zolpidem tartrate 10 MG Oral Tablet	PSN	7da75d2b-905c-4fdf-bc53-1358c6477755	2
854873	zolpidem tartrate 10 MG Oral Tablet	PSN	26e20f53-c042-eac0-e063-6394a90acfca	2
854876	zolpidem tartrate 5 MG Oral Tablet	PSN	b87ea23e-2d54-4d10-8f10-72d4c62f3245	2
854876	zolpidem tartrate 5 MG Oral Tablet	PSN	e5e2d31b-ce26-78b0-e053-2a95a90ac491	2
854873	zolpidem tartrate 10 MG Oral Tablet	SCD	fc76ab4c-3607-39c3-e053-6394a90a6877	2
854873	zolpidem tartrate 10 MG Oral Tablet	SCD	b87ea23e-2d54-4d10-8f10-72d4c62f3245	2
854873	zolpidem tartrate 10 MG Oral Tablet	SCD	e5e2d31b-ce26-78b0-e053-2a95a90ac491	2
854873	zolpidem tartrate 10 MG Oral Tablet	SCD	11934d96-36f4-4c32-b14a-a665c7400f3b	2
854873	zolpidem tartrate 10 MG Oral Tablet	SCD	7da75d2b-905c-4fdf-bc53-1358c6477755	2
854873	zolpidem tartrate 10 MG Oral Tablet	SCD	26e20f53-c042-eac0-e063-6394a90acfca	2
854876	zolpidem tartrate 5 MG Oral Tablet	SCD	b87ea23e-2d54-4d10-8f10-72d4c62f3245	2
854876	zolpidem tartrate 5 MG Oral Tablet	SCD	e5e2d31b-ce26-78b0-e053-2a95a90ac491	2
854873	zolpidem tartrate 10 MG Oral Tablet	PSN	7efb19d9-32bb-4737-ac7f-2ec21eca255c	1
854873	zolpidem tartrate 10 MG Oral Tablet	PSN	e68a1b3b-b3d1-495e-be46-466113e7dbd6	1
854873	zolpidem tartrate 10 MG Oral Tablet	PSN	9245ff4b-a11f-4afd-8fa0-842fcfee4306	1
854873	zolpidem tartrate 10 MG Oral Tablet	PSN	06a454bc-50d0-45de-87db-f3e3502e3bb0	1
854876	zolpidem tartrate 5 MG Oral Tablet	PSN	7efb19d9-32bb-4737-ac7f-2ec21eca255c	1
854876	zolpidem tartrate 5 MG Oral Tablet	PSN	06a454bc-50d0-45de-87db-f3e3502e3bb0	1
854873	zolpidem tartrate 10 MG Oral Tablet	SCD	7efb19d9-32bb-4737-ac7f-2ec21eca255c	1
854873	zolpidem tartrate 10 MG Oral Tablet	SCD	9245ff4b-a11f-4afd-8fa0-842fcfee4306	1
854873	zolpidem tartrate 10 MG Oral Tablet	SCD	e68a1b3b-b3d1-495e-be46-466113e7dbd6	1
854873	zolpidem tartrate 10 MG Oral Tablet	SCD	06a454bc-50d0-45de-87db-f3e3502e3bb0	1
854876	zolpidem tartrate 5 MG Oral Tablet	SCD	7efb19d9-32bb-4737-ac7f-2ec21eca255c	1
854876	zolpidem tartrate 5 MG Oral Tablet	SCD	06a454bc-50d0-45de-87db-f3e3502e3bb0	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
13668-008-01	13668000801	100 TABLET in 1 BOTTLE (13668-008-01)	100 tablet	2007-09-05	0000-00-00	No	No	Current
13668-008-05	13668000805	500 TABLET in 1 BOTTLE (13668-008-05)	500 tablet	2007-09-05	0000-00-00	No	No	Current
13668-008-10	13668000810	1000 TABLET in 1 BOTTLE (13668-008-10)	1000 tablet	2007-09-05	0000-00-00	No	No	Current
13668-008-15	13668000815	1500 TABLET in 1 BOTTLE (13668-008-15)	1500 tablet	2007-09-05	0000-00-00	No	No	Current
13668-008-30	13668000830	30 TABLET in 1 BOTTLE (13668-008-30)	30 tablet	2007-09-05	0000-00-00	No	No	Current
13668-008-74	13668000874	100 TABLET in 1 CARTON (13668-008-74)	100 tablet	2007-09-05	0000-00-00	No	No	Current
13668-008-90	13668000890	90 TABLET in 1 BOTTLE (13668-008-90)	90 tablet	2007-09-05	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	St. Mary's Medical Park Pharmacy	2026-07-17	HUMAN PRESCRIPTION DRUG LABEL	9
ZOLPIDEM TARTRATE - Torrent Pharmaceuticals Limited \| Torrent Pharma, Inc. \| Piramal Pharma Limited	Torrent Pharmaceuticals Limited \| Torrent Pharma, Inc. \| Piramal Pharma Limited	2026-07-02	HUMAN PRESCRIPTION DRUG LABEL	25
ZOLPIDEM TARTRATE - Calvin Scott & Co., Inc.	Calvin Scott & Co., Inc.	2026-01-15	HUMAN PRESCRIPTION DRUG LABEL	2
ZOLPIDEM TARTRATE	Northwind Health Company, LLC	2025-12-26	HUMAN PRESCRIPTION DRUG LABEL	2
ZOLPIDEM TARTRATE	Preferred Pharmaceuticals, Inc.	2025-10-08	HUMAN PRESCRIPTION DRUG LABEL	12
ZOLPIDEM TARTRATE	Major Pharmaceuticals	2025-07-21	HUMAN PRESCRIPTION DRUG LABEL	19
ZOLPIDEM TARTRATE - Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-02-09	HUMAN PRESCRIPTION DRUG LABEL	2
Zolpidem Tartrate Tablets	Advanced Rx of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	7
Zolpidem Tartrate Tablets	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	2
ZOLPIDEM TARTRATE	Lake Erie Medical DBA Quality Care Products LLC	2024-12-17	HUMAN PRESCRIPTION DRUG LABEL	12
ZOLPIDEM TARTRATE - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2024-10-22	HUMAN PRESCRIPTION DRUG LABEL	5
ZOLPIDEM TARTRATE	PD-Rx Pharmaceuticals, Inc.	2024-09-20	HUMAN PRESCRIPTION DRUG LABEL	32
ZOLPIDEM TARTRATE - Bryant Ranch Prepack	Bryant Ranch Prepack	2024-08-28	HUMAN PRESCRIPTION DRUG LABEL	15
ZOLPIDEM TARTRATE - NuCare Pharmaceuticals, Inc \| NuCare Pharmaceuticals, Inc.	NuCare Pharmaceuticals, Inc \| NuCare Pharmaceuticals, Inc.	2024-07-16	HUMAN PRESCRIPTION DRUG LABEL	6
ZOLPIDEM TARTRATE	DirectRX	2024-06-26	HUMAN PRESCRIPTION DRUG LABEL	4
ZOLPIDEM TARTRATE - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2024-06-20	HUMAN PRESCRIPTION DRUG LABEL	3
ZOLPIDEM TARTRATE - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2024-06-19	HUMAN PRESCRIPTION DRUG LABEL	3
ZOLPIDEM TARTRATE - REMEDYREPACK INC.	REMEDYREPACK INC.	2024-04-19	HUMAN PRESCRIPTION DRUG LABEL	6
ZOLPIDEM TARTRATE - A-S Medication Solutions	A-S Medication Solutions	2023-09-14	HUMAN PRESCRIPTION DRUG LABEL	1
ZOLPIDEM TARTRATE - RPK Pharmaceuticals, Inc.	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	7
ZOLPIDEM TARTRATE - Denton Pharma, Inc. DBA Northwind Pharmaceuticals	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-01	HUMAN PRESCRIPTION DRUG LABEL	4