Home NDC 0054-0084 Zaleplon
Product NDC 0054-0084
11-digit product format 000540084
Labeler code 0054
Product ID 0054-0084_d97e7e61-defc-47f5-aeca-11cecae47e79
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Zaleplon
Dosage form CAPSULE
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA077237
Marketing category ANDA
Marketing start 2008-06-06
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 A077237-001 ZALEPLON ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 A077237-002 ZALEPLON ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06
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 A077237-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077237-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077237-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077237-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077237-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077237-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077237-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077237-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077237-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077237-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077237-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077237-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077237-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077237-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077237-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077237-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077237-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077237-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077237-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077237-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077237-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077237-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077237-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077237-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077237-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077237-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077237-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077237-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077237-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077237-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077237-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077237-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077237-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077237-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077237-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077237-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077237-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077237-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077237-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A077237-002 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.
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0054-0084-25 Zaleplon 100 in 1 BOTTLE CAPSULE 100 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ZALEPLON ACTIVE INGREDIENT S62U433RMH ZALEPLON CAPSULE [ROXANE LABORATORIES, INC] 5 ZALEPLON ACTIVE MOIETY S62U433RMH ZALEPLON CAPSULE [ROXANE LABORATORIES, INC] 5 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK ZALEPLON CAPSULE [ROXANE LABORATORIES, INC] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ZALEPLON CAPSULE [ROXANE LABORATORIES, INC] 5 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G ZALEPLON CAPSULE [ROXANE LABORATORIES, INC] 5 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ZALEPLON CAPSULE [ROXANE LABORATORIES, INC] 5 GELATIN INACTIVE INGREDIENT 2G86QN327L ZALEPLON CAPSULE [ROXANE LABORATORIES, INC] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ZALEPLON CAPSULE [ROXANE LABORATORIES, INC] 5 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ZALEPLON CAPSULE [ROXANE LABORATORIES, INC] 5 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J ZALEPLON CAPSULE [ROXANE LABORATORIES, INC] 5 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ZALEPLON CAPSULE [ROXANE LABORATORIES, INC] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ZALEPLON CAPSULE [ROXANE LABORATORIES, INC] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-0084 ZALEPLON CAPSULE [HIKMA PHARMACEUTICALS USA INC.] 11 Current NDC, Legacy NDC, 1 package rows 20250330_cadd9d75-2139-4fab-94ce-2992e6a55780.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0054-0084-25 00054008425 100 CAPSULE in 1 BOTTLE (0054-0084-25) 100 capsule 2008-06-06 0000-00-00 No No Current