zaleplon

Product NDC: 33261-486
11-digit product format: 332610486
Labeler code: 33261
Product ID: 33261-486_102c0c6c-be48-40e6-8299-031e8f3dc843
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: zaleplon
Dosage form: CAPSULE
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA078989
Marketing category: ANDA
Marketing start: 2009-05-05
Marketing end: 0000-00-00
Substance: ZALEPLON
Active strength: 5 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: 2019-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	33261-486		I	Inactivated by FDA	2026-08-11
excluded package	package	33261-486	33261-486-30	I	Inactivated by FDA	2026-08-11
excluded package	package	33261-486	33261-486-60	I	Inactivated by FDA	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 2 · 63 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-486-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-486-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-486-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-486-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-486-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-486-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-486-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-486-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-486-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-486-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	33261-486-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	33261-486-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	33261-486-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	33261-486-60	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	33261-486-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	33261-486-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	33261-486-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	33261-486-60	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	33261-486-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	33261-486-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	33261-486-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	33261-486-60	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	33261-486-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	33261-486-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	33261-486-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	33261-486-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	33261-486-30	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	33261-486-60	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	33261-486-30	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	33261-486-60	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	33261-486-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	33261-486-60	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	33261-486-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	33261-486-60	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	33261-486-30	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	33261-486-60	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	33261-486-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	33261-486-60	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	33261-486-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	33261-486-60	`e2bbac7714bc…`	`27bdfed8d636…`

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
A078989-001	ZALEPLON	ZALEPLON	5MG	CAPSULE / ORAL	AB		2008-06-06
A078989-002	ZALEPLON	ZALEPLON	10MG	CAPSULE / ORAL	AB	RS	2008-06-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078989-001	AB
A078989-002	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078989-001	ZALEPLON	5MG	CAPSULE / ORAL	AB		2008-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078989-002	ZALEPLON	10MG	CAPSULE / ORAL	AB	RS	2008-06-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078989-001	ZALEPLON	5MG	CAPSULE / ORAL	AB		2008-06-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078989-002	ZALEPLON	10MG	CAPSULE / ORAL	AB	RS	2008-06-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078989-001	ZALEPLON	5MG	CAPSULE / ORAL	AB		2008-06-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078989-002	ZALEPLON	10MG	CAPSULE / ORAL	AB		2008-06-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078989-001	ZALEPLON	5MG	CAPSULE / ORAL	AB		2008-06-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078989-002	ZALEPLON	10MG	CAPSULE / ORAL	AB		2008-06-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078989-001	ZALEPLON	5MG	CAPSULE / ORAL	AB		2008-06-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078989-002	ZALEPLON	10MG	CAPSULE / ORAL	AB		2008-06-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078989-001	ZALEPLON	5MG	CAPSULE / ORAL	AB		2008-06-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078989-002	ZALEPLON	10MG	CAPSULE / ORAL	AB		2008-06-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078989-001	ZALEPLON	5MG	CAPSULE / ORAL	AB		2008-06-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078989-002	ZALEPLON	10MG	CAPSULE / ORAL	AB		2008-06-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078989-001	ZALEPLON	5MG	CAPSULE / ORAL	AB		2008-06-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078989-002	ZALEPLON	10MG	CAPSULE / ORAL	AB		2008-06-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078989-001	ZALEPLON	5MG	CAPSULE / ORAL	AB		2008-06-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078989-002	ZALEPLON	10MG	CAPSULE / ORAL	AB		2008-06-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078989-001	ZALEPLON	5MG	CAPSULE / ORAL	AB		2008-06-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078989-002	ZALEPLON	10MG	CAPSULE / ORAL	AB		2008-06-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078989-001	ZALEPLON	5MG	CAPSULE / ORAL	AB		2008-06-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078989-002	ZALEPLON	10MG	CAPSULE / ORAL	AB		2008-06-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078989-001	ZALEPLON	5MG	CAPSULE / ORAL	AB		2008-06-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078989-002	ZALEPLON	10MG	CAPSULE / ORAL	AB		2008-06-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078989-001	ZALEPLON	5MG	CAPSULE / ORAL	AB		2008-06-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078989-002	ZALEPLON	10MG	CAPSULE / ORAL	AB		2008-06-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078989-001	ZALEPLON	5MG	CAPSULE / ORAL	AB		2008-06-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078989-002	ZALEPLON	10MG	CAPSULE / ORAL	AB		2008-06-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078989-001	ZALEPLON	5MG	CAPSULE / ORAL	AB		2008-06-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078989-002	ZALEPLON	10MG	CAPSULE / ORAL	AB		2008-06-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078989-001	ZALEPLON	5MG	CAPSULE / ORAL	AB		2008-06-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078989-002	ZALEPLON	10MG	CAPSULE / ORAL	AB		2008-06-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078989-001	ZALEPLON	5MG	CAPSULE / ORAL	AB		2008-06-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078989-002	ZALEPLON	10MG	CAPSULE / ORAL	AB		2008-06-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078989-001	ZALEPLON	5MG	CAPSULE / ORAL	AB		2008-06-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078989-002	ZALEPLON	10MG	CAPSULE / ORAL	AB		2008-06-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078989-001	ZALEPLON	5MG	CAPSULE / ORAL	AB		2008-06-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078989-002	ZALEPLON	10MG	CAPSULE / ORAL	AB		2008-06-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078989-001	ZALEPLON	5MG	CAPSULE / ORAL	AB		2008-06-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078989-002	ZALEPLON	10MG	CAPSULE / ORAL	AB		2008-06-06	`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	A078989-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078989-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078989-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078989-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078989-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078989-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078989-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078989-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078989-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078989-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078989-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078989-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078989-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078989-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078989-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078989-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078989-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078989-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078989-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078989-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078989-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078989-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078989-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078989-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078989-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078989-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078989-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078989-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078989-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078989-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078989-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078989-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078989-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078989-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078989-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078989-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078989-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078989-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078989-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078989-002	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
33261-486-30	2020-01-31	C162847	48780-1	9d75b9cf-f263-f424-e053-dadaa90a57ce	Zaleplon Capsules
33261-486-60	2020-01-31	C162847	48780-1	9d75b9cf-f263-f424-e053-dadaa90a57ce	Zaleplon Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
33261-486-30	zaleplon	30 in 1 BOTTLE, PLASTIC	CAPSULE	30		1
33261-486-60	zaleplon	60 in 1 BOTTLE, PLASTIC	CAPSULE	60		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
33261-486-30	EA - Each	33261-486	193c05d0-1eab-44d9-aace-239c61411615	1	2015-10-02
33261-486-60	EA - Each	33261-486	41a2bf02-6a60-40ca-a009-27786c60900e	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZALEPLON	ACTIVE INGREDIENT	S62U433RMH	ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
ZALEPLON	ACTIVE MOIETY	S62U433RMH	ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33261-486	ZALEPLON CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 2 package rows	20140213_423a4d98-f648-4eed-bd20-857c5a8dde5b.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
zaleplon	ZALEPLON	PD-Rx Pharmaceuticals, Inc.	2cc7adee-2c4c-4fed-9914-545e70dba773	2025-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078989 application number: ANDA078989
zaleplon	ZALEPLON	Preferred Pharmaceuticals Inc.	b0476859-07af-47f1-aec7-61aea0d99d24	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078989 application number: ANDA078989
zaleplon	ZALEPLON	A-S Medication Solutions	8276a418-6a4c-4b81-8170-2d3838576c6d	2024-01-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078989 application number: ANDA078989
zaleplon	ZALEPLON	Bryant Ranch Prepack	d8c88122-ce04-4caf-bd4d-0a4368ea89ad	2023-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078989 application number: ANDA078989
zaleplon	ZALEPLON	Bryant Ranch Prepack	b8032b14-5068-19d5-e063-839ed25d7200	2023-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078989 application number: ANDA078989
zaleplon	ZALEPLON	Unichem Pharmaceuticals (USA), Inc.	57a1a11d-7767-4caf-b98a-75d7561d9165	2021-06-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078989 application number: ANDA078989

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	423a4d98-f648-4eed-bd20-857c5a8dde5b	1
313762	zaleplon 5 MG Oral Capsule	PSN	423a4d98-f648-4eed-bd20-857c5a8dde5b	1
313761	zaleplon 10 MG Oral Capsule	SCD	423a4d98-f648-4eed-bd20-857c5a8dde5b	1
313762	zaleplon 5 MG Oral Capsule	SCD	423a4d98-f648-4eed-bd20-857c5a8dde5b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
33261-486-30	33261048630	30 in 1 BOTTLE, PLASTIC	Historical
33261-486-60	33261048660	60 in 1 BOTTLE, PLASTIC	Historical