zaleplon

Product NDC: 29300-131
11-digit product format: 293000131
Labeler code: 29300
Product ID: 29300-131_24b4fbb6-3d16-48f7-864c-71e85813a9a2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: zaleplon
Dosage form: CAPSULE
Route: ORAL
Labeler: Unichem Pharmaceuticals (USA), Inc.
Application: ANDA078989
Marketing category: ANDA
Marketing start: 2009-05-05
Substance: ZALEPLON
Active strength: 5 mg/1
Pharmacologic classes: Central Nervous System Depression [PE], GABA A Agonists [MoA], gamma-Aminobutyric Acid A Receptor Agonist [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
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: zaleplon
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZALEPLON	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
S62U433RMH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313761	Internal RxNorm lookup
313762	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
57a1a11d-7767-4caf-b98a-75d7561d9165	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
29300-131-01	zaleplon	100 in 1 BOTTLE, PLASTIC	CAPSULE	100	10
29300-131-05	zaleplon	500 in 1 BOTTLE, PLASTIC	CAPSULE	500	10
29300-131-13	zaleplon	30 in 1 BOTTLE, PLASTIC	CAPSULE	30	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
29300-131-01	EA - Each	29300-131	5fb0f848-5458-4942-96f5-129fa816f84a	1	2013-02-13

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
29300-131	ZALEPLON CAPSULE [UNICHEM PHARMACEUTICALS (USA), INC.]	10	Current NDC, Legacy NDC, 3 package rows	20210626_57a1a11d-7767-4caf-b98a-75d7561d9165.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 ndc (product): 29300-131

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	57a1a11d-7767-4caf-b98a-75d7561d9165	10
313762	zaleplon 5 MG Oral Capsule	PSN	57a1a11d-7767-4caf-b98a-75d7561d9165	10
313761	zaleplon 10 MG Oral Capsule	SCD	57a1a11d-7767-4caf-b98a-75d7561d9165	10
313762	zaleplon 5 MG Oral Capsule	SCD	57a1a11d-7767-4caf-b98a-75d7561d9165	10
313762	zaleplon 5 MG Oral Capsule	PSN	d8c88122-ce04-4caf-bd4d-0a4368ea89ad	5
313762	zaleplon 5 MG Oral Capsule	SCD	d8c88122-ce04-4caf-bd4d-0a4368ea89ad	5
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
313762	zaleplon 5 MG Oral Capsule	PSN	f493f828-9fdd-4723-9fc7-f691d3879696	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
313762	zaleplon 5 MG Oral Capsule	SCD	f493f828-9fdd-4723-9fc7-f691d3879696	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
29300-131-01	29300013101	100 CAPSULE in 1 BOTTLE, PLASTIC (29300-131-01)	100 capsule	2009-05-05	0000-00-00	No	No	Current
29300-131-05	29300013105	500 CAPSULE in 1 BOTTLE, PLASTIC (29300-131-05)	500 capsule	2009-05-05	0000-00-00	No	No	Current
29300-131-13	29300013113	30 CAPSULE in 1 BOTTLE, PLASTIC (29300-131-13)	30 capsule	2009-05-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zaleplon Capsules USP	Bryant Ranch Prepack	2023-11-06	HUMAN PRESCRIPTION DRUG LABEL	5
Zaleplon Capsules USP	Unichem Pharmaceuticals (USA), Inc.	2021-06-28	HUMAN PRESCRIPTION DRUG LABEL	10
Zaleplon Capsules	Aidarex Pharmaceuticals LLC	2014-01-31	HUMAN PRESCRIPTION DRUG LABEL	1
Zaleplon Capsules	Rebel Distributors Corp	2012-03-20	HUMAN PRESCRIPTION DRUG LABEL	1