Zaleplon

Product NDC: 42043-211
Requested package NDC: 42043-211-01
11-digit product format: 420430211
Labeler code: 42043
Product ID: 42043-211_3d5ebb15-7a9d-47e1-b0a7-f6d1fee80d3b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Zaleplon
Dosage form: CAPSULE
Route: ORAL
Labeler: OrchidPharma Inc
Application: ANDA090374
Marketing category: ANDA
Marketing start: 2018-06-20
Marketing end: 0000-00-00
Substance: ZALEPLON
Active strength: 10 mg/1
Pharmacologic classes: gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	42043-211	42043-211-01	D	Discontinued by firm		2026-08-11

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A090374-001	ZALEPLON	ZALEPLON	5MG	CAPSULE / ORAL	AB		2009-09-17
A090374-002	ZALEPLON	ZALEPLON	10MG	CAPSULE / ORAL	AB		2009-09-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090374-001	AB
A090374-002	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	A090374-001	ZALEPLON	5MG	CAPSULE / ORAL	AB	2009-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090374-002	ZALEPLON	10MG	CAPSULE / ORAL	AB	2009-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090374-001	ZALEPLON	5MG	CAPSULE / ORAL	AB	2009-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090374-002	ZALEPLON	10MG	CAPSULE / ORAL	AB	2009-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090374-001	ZALEPLON	5MG	CAPSULE / ORAL	AB	2009-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090374-002	ZALEPLON	10MG	CAPSULE / ORAL	AB	2009-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090374-001	ZALEPLON	5MG	CAPSULE / ORAL	AB	2009-09-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090374-002	ZALEPLON	10MG	CAPSULE / ORAL	AB	2009-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090374-001	ZALEPLON	5MG	CAPSULE / ORAL	AB	2009-09-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090374-002	ZALEPLON	10MG	CAPSULE / ORAL	AB	2009-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090374-001	ZALEPLON	5MG	CAPSULE / ORAL	AB	2009-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090374-002	ZALEPLON	10MG	CAPSULE / ORAL	AB	2009-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090374-001	ZALEPLON	5MG	CAPSULE / ORAL	AB	2009-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090374-002	ZALEPLON	10MG	CAPSULE / ORAL	AB	2009-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090374-001	ZALEPLON	5MG	CAPSULE / ORAL	AB	2009-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090374-002	ZALEPLON	10MG	CAPSULE / ORAL	AB	2009-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090374-001	ZALEPLON	5MG	CAPSULE / ORAL	AB	2009-09-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090374-002	ZALEPLON	10MG	CAPSULE / ORAL	AB	2009-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090374-001	ZALEPLON	5MG	CAPSULE / ORAL	AB	2009-09-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090374-002	ZALEPLON	10MG	CAPSULE / ORAL	AB	2009-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090374-001	ZALEPLON	5MG	CAPSULE / ORAL	AB	2009-09-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090374-002	ZALEPLON	10MG	CAPSULE / ORAL	AB	2009-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090374-001	ZALEPLON	5MG	CAPSULE / ORAL	AB	2009-09-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090374-002	ZALEPLON	10MG	CAPSULE / ORAL	AB	2009-09-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090374-001	ZALEPLON	5MG	CAPSULE / ORAL	AB	2009-09-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090374-002	ZALEPLON	10MG	CAPSULE / ORAL	AB	2009-09-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090374-001	ZALEPLON	5MG	CAPSULE / ORAL	AB	2009-09-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090374-002	ZALEPLON	10MG	CAPSULE / ORAL	AB	2009-09-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090374-001	ZALEPLON	5MG	CAPSULE / ORAL	AB	2009-09-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090374-002	ZALEPLON	10MG	CAPSULE / ORAL	AB	2009-09-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090374-001	ZALEPLON	5MG	CAPSULE / ORAL	AB	2009-09-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090374-002	ZALEPLON	10MG	CAPSULE / ORAL	AB	2009-09-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090374-001	ZALEPLON	5MG	CAPSULE / ORAL	AB	2009-09-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090374-002	ZALEPLON	10MG	CAPSULE / ORAL	AB	2009-09-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090374-001	ZALEPLON	5MG	CAPSULE / ORAL	AB	2009-09-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090374-002	ZALEPLON	10MG	CAPSULE / ORAL	AB	2009-09-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090374-001	ZALEPLON	5MG	CAPSULE / ORAL	AB	2009-09-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090374-002	ZALEPLON	10MG	CAPSULE / ORAL	AB	2009-09-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090374-001	ZALEPLON	5MG	CAPSULE / ORAL	AB	2009-09-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090374-002	ZALEPLON	10MG	CAPSULE / ORAL	AB	2009-09-17	`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	A090374-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090374-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090374-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090374-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090374-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090374-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090374-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090374-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090374-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090374-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090374-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090374-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090374-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090374-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090374-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090374-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090374-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090374-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090374-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090374-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090374-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090374-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090374-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090374-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090374-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090374-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090374-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090374-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090374-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090374-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090374-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090374-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090374-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090374-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090374-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090374-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090374-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090374-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090374-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090374-002	AB	1	`782e0a99824c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
11ca9bc5-afb0-a2d5-938a-c2d33f89f4ab	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42043-211-01	2024-03-01	C162847	48780-1	0191ceaa-63d6-198a-e063-dbdaa90aec3e	Zaleplon Capsules , USP CIV
42043-211-01	2023-07-28	C162847	48780-1	0191ceaa-63d6-198a-e063-dbdaa90aec3e	Zaleplon Capsules , USP CIV

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42043-211-01	EA - Each	42043-211	83c523d9-b9d1-4e02-8a9e-ec5843f6abb4	1	2019-01-24

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zaleplon	ZALEPLON	Preferred Pharmaceuticals Inc.	d58138d1-3378-482c-a401-958dabe1be7d	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090374 application number: ANDA090374
Zaleplon	ZALEPLON	Bryant Ranch Prepack	517953c8-22ad-41af-a869-b7e4e5b291ae	2024-08-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090374 application number: ANDA090374
Zaleplon	ZALEPLON	Bionpharma Inc.	53103d2f-4453-49a8-9e36-888d919879f6	2024-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090374 application number: ANDA090374

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
S62U433RMH	ZALEPLON	151319-34-5	ZALEPLON

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313761	zaleplon 10 MG Oral Capsule	PSN	7565a029-6542-45fe-b823-e522d0583fd7	5
313761	zaleplon 10 MG Oral Capsule	SCD	7565a029-6542-45fe-b823-e522d0583fd7	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42043-211-01	42043021101	100 CAPSULE in 1 BOTTLE (42043-211-01)	100 capsule	2018-06-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zaleplon Capsules , USP CIV	Bryant Ranch Prepack	2022-02-14	HUMAN PRESCRIPTION DRUG LABEL	5
Zaleplon Capsules , USP CIV	OrchidPharma Inc \| Orchid Pharma Ltd \| Orchid Healthcare (a division of Orchid Pharma Ltd)	2022-01-13	HUMAN PRESCRIPTION DRUG LABEL	8