Home NDC 71335-2468 Zaleplon
Product NDC 71335-2468
11-digit product format 713352468
Labeler code 71335
Product ID 71335-2468_5cbad0f1-c66b-4bd0-bfb0-530333c5e4d5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Zaleplon
Dosage form CAPSULE
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA090374
Marketing category ANDA
Marketing start 2024-02-17
Substance ZALEPLON
Active strength 10 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 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.
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 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.
Additional Listing Data#
Finished product Yes
Brand name base Zaleplon
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZALEPLON 10 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313761 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71335-2468-1 Zaleplon 15 in 1 BOTTLE CAPSULE 15 2 71335-2468-2 Zaleplon 30 in 1 BOTTLE CAPSULE 30 2 71335-2468-3 Zaleplon 60 in 1 BOTTLE CAPSULE 60 2 71335-2468-4 Zaleplon 90 in 1 BOTTLE CAPSULE 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-2468 ZALEPLON CAPSULE [BRYANT RANCH PREPACK] 2 Current NDC, 4 package rows 20240817_517953c8-22ad-41af-a869-b7e4e5b291ae.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71335-2468-1 71335246801 15 CAPSULE in 1 BOTTLE (71335-2468-1) 15 capsule 2024-08-16 No No Current 71335-2468-2 71335246802 30 CAPSULE in 1 BOTTLE (71335-2468-2) 30 capsule 2024-08-16 No No Current 71335-2468-3 71335246803 60 CAPSULE in 1 BOTTLE (71335-2468-3) 60 capsule 2024-08-16 No No Current 71335-2468-4 71335246804 90 CAPSULE in 1 BOTTLE (71335-2468-4) 90 capsule 2024-08-16 No No Current