ZOLPIDEM TARTRATE

Product NDC: 51407-942
Requested package NDC: 51407-942-01
11-digit product format: 514070942
Labeler code: 51407
Product ID: 51407-942_509ba752-e8a7-b190-e063-6294a90a5794
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: zolpidem tartrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Golden State Medical Supply, Inc.
Application: ANDA077214
Marketing category: ANDA
Marketing start: 2007-04-23
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: 2027-12-31
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
A077214-001	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB		2007-04-23
A077214-002	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
A077214-001	AB
A077214-002	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	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077214-002	ZOLPIDEM TARTRATE	10MG	TABLET / ORAL	AB	2007-04-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077214-001	ZOLPIDEM TARTRATE	5MG	TABLET / ORAL	AB	2007-04-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077214-002	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	A077214-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077214-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077214-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077214-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077214-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077214-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077214-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077214-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077214-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077214-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077214-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077214-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077214-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077214-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077214-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077214-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077214-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077214-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077214-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077214-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077214-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077214-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077214-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077214-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077214-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077214-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077214-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077214-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077214-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077214-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077214-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077214-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077214-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077214-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077214-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077214-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077214-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077214-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077214-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077214-002	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
2b5cf535-ccdc-ecd7-e063-6394a90a726e	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
51407-942-01	ZOLPIDEM TARTRATE	100 in 1 BOTTLE	TABLET, FILM COATED	100	2
51407-942-10	ZOLPIDEM TARTRATE	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	2
51407-942-30	ZOLPIDEM TARTRATE	30 in 1 BOTTLE	TABLET, FILM COATED	30	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51407-942-01	EA - Each	51407-942	cf3f555d-b010-431c-a585-5f2da03bef54	1	2025-02-10
51407-942-10	EA - Each	51407-942	ec86d0d8-3b24-4c4f-8dc2-c39a2855507f	1	2025-02-10
51407-942-30	EA - Each	51407-942	5459f785-4f77-4b5d-a5f9-83d331c831ba	1	2025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51407-942	ZOLPIDEM TARTRATE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	1	Current NDC, 3 package rows	20250112_2b5cf535-ccdc-ecd7-e063-6394a90a726e.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 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Golden State Medical Supply, Inc.	2b5cf535-ccdc-ecd7-e063-6394a90a726e	2026-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214 ndc (package): 51407-942-01 ndc (product): 51407-942 ndc11 (package): 51407094201
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	The ACME Laboratories Ltd.	5679ed64-8424-4e63-a3c9-91d80fff2ca6	2026-03-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	3882d72d-686b-406b-e063-6294a90a0b89	2025-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	349053e4-9885-ec0b-e063-6294a90ad79a	2025-05-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	1e15d6e3-8d06-0936-e063-6394a90ab8db	2025-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	1e13ad50-f846-813a-e063-6294a90a5878	2024-09-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	8cef5718-c562-43c3-8abe-a2fc5235ad2a	2024-09-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	fff2e7fc-2f7e-43c9-bfb3-d929ecc9eb72	2024-09-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	74c4e793-3444-4d3d-8211-26374349ab1e	2024-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Advanced Rx of Tennessee, LLC	1fa86b79-8809-35f4-e063-6394a90a4377	2024-08-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Golden State Medical Supply, Inc.	1a8f7696-0d02-dd1f-e063-6394a90a5866	2024-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	70d7cfc3-7e54-4cd8-8911-7cf115d5c820	2024-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	23bce69d-7918-42c2-8020-e22f292ff31f	2024-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	3aa7e88b-7929-45ac-9e81-03f4abf28e94	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	1e5b61b6-a5bd-4f09-9d34-905ce32f1899	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	c6824c69-76bc-4ca0-a6b1-5cddc2c42fc9	2024-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	df130798-1458-455b-a4e1-c33c4ecee43b	2023-12-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Bryant Ranch Prepack	33094305-4bbd-4b52-9079-8853d5f83682	2023-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	ACI Healthcare USA, Inc	021153ce-fe27-4ed1-8d88-b4157b0ed734	2023-11-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214
Zolpidem	ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	8581cfad-525b-4b16-b116-a5138d9fda52	2022-10-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077214 application number: ANDA077214

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	2b5cf535-ccdc-ecd7-e063-6394a90a726e	2
854876	zolpidem tartrate 5 MG Oral Tablet	PSN	2b5cf535-ccdc-ecd7-e063-6394a90a726e	2
854873	zolpidem tartrate 10 MG Oral Tablet	SCD	2b5cf535-ccdc-ecd7-e063-6394a90a726e	2
854876	zolpidem tartrate 5 MG Oral Tablet	SCD	2b5cf535-ccdc-ecd7-e063-6394a90a726e	2
854873	zolpidem tartrate 10 MG Oral Tablet	PSN	3882d72d-686b-406b-e063-6294a90a0b89	1
854873	zolpidem tartrate 10 MG Oral Tablet	SCD	3882d72d-686b-406b-e063-6294a90a0b89	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
51407-942-01	51407094201	100 TABLET, FILM COATED in 1 BOTTLE (51407-942-01)	2024-12-06	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ZOLPIDEM TARTRATE	Golden State Medical Supply, Inc.	2026-04-29	HUMAN PRESCRIPTION DRUG LABEL	2
ZOLPIDEM TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	2025-06-26	HUMAN PRESCRIPTION DRUG LABEL	1