ZOLPIDEM TARTRATE

Product NDC: 43063-639
11-digit product format: 430630639
Labeler code: 43063
Product ID: 43063-639_e5f84ba7-3fe4-5425-e053-2995a90ac47a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: zolpidem tartrate
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA077903
Marketing category: ANDA
Marketing start: 2007-09-05
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 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43063-639		D	Discontinued by firm	2026-08-07
excluded package	package	43063-639	43063-639-01	D	Discontinued by firm	2026-08-07
excluded package	package	43063-639	43063-639-06	D	Discontinued by firm	2026-08-07
excluded package	package	43063-639	43063-639-10	D	Discontinued by firm	2026-08-07
excluded package	package	43063-639	43063-639-14	D	Discontinued by firm	2026-08-07
excluded package	package	43063-639	43063-639-15	D	Discontinued by firm	2026-08-07
excluded package	package	43063-639	43063-639-21	D	Discontinued by firm	2026-08-07
excluded package	package	43063-639	43063-639-30	D	Discontinued by firm	2026-08-07
excluded package	package	43063-639	43063-639-60	D	Discontinued by firm	2026-08-07

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 · 9 matching rows.

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

Dataset, Scope, Package NDC table
Dataset	Scope	Package NDC
excluded product	product
excluded package	package	43063-639-10
excluded package	package	43063-639-30
excluded package	package	43063-639-06
excluded package	package	43063-639-15
excluded package	package	43063-639-21
excluded package	package	43063-639-60
excluded package	package	43063-639-14
excluded package	package	43063-639-01

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…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-639-01	EA - Each	43063-639	8f1fecba-5386-419c-a6c4-019e84170322	1	2016-03-04
43063-639-06	EA - Each	43063-639	8419881f-104e-4636-a683-dab7bbf2c2ea	1	2016-03-04
43063-639-10	EA - Each	43063-639	0b893fb9-35ed-4e79-a58f-5c3f6c4ea117	1	2016-03-04
43063-639-14	EA - Each	43063-639	8e795078-c624-43f4-8a3a-c158703df8b9	1	2016-03-04
43063-639-15	EA - Each	43063-639	d2be50b0-ac54-454f-aa3a-2d167dadb373	1	2016-03-04
43063-639-21	EA - Each	43063-639	bde6716a-f3e4-4b66-81fb-2f4e99eda711	1	2016-03-04
43063-639-30	EA - Each	43063-639	5ba4ddc0-52f8-4b5b-ad39-d316d425c7bd	1	2016-03-04
43063-639-60	EA - Each	43063-639	548e7092-29b2-44b6-992b-250e634f15e0	1	2016-03-04

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43063-639	ZOLPIDEM TARTRATE TABLET [PD-RX PHARMACEUTICALS, INC.]	32	Legacy NDC	20240925_24722308-dbb8-3a2d-e054-00144ff8d46c.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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-639-01	43063063901	100 TABLET in 1 BOTTLE, PLASTIC (43063-639-01)	100 tablet	2015-11-13	0000-00-00	No	No	Current
43063-639-06	43063063906	6 TABLET in 1 BOTTLE, PLASTIC (43063-639-06)	6 tablet	2015-11-13	0000-00-00	No	No	Current
43063-639-10	43063063910	10 TABLET in 1 BOTTLE, PLASTIC (43063-639-10)	10 tablet	2015-11-13	0000-00-00	No	No	Current
43063-639-14	43063063914	14 TABLET in 1 BOTTLE, PLASTIC (43063-639-14)	14 tablet	2015-11-13	0000-00-00	No	No	Current
43063-639-15	43063063915	15 TABLET in 1 BOTTLE, PLASTIC (43063-639-15)	15 tablet	2015-11-13	0000-00-00	No	No	Current
43063-639-21	43063063921	21 TABLET in 1 BOTTLE, PLASTIC (43063-639-21)	21 tablet	2015-11-13	0000-00-00	No	No	Current
43063-639-30	43063063930	30 TABLET in 1 BOTTLE, PLASTIC (43063-639-30)	30 tablet	2015-11-13	0000-00-00	No	No	Current
43063-639-60	43063063960	60 TABLET in 1 BOTTLE, PLASTIC (43063-639-60)	60 tablet	2015-11-13	0000-00-00	No	No	Current