Home NDC 43063-505-30 ZALEPLON
Product NDC 43063-505
Requested package NDC 43063-505-30
11-digit product format 430630505
Labeler code 43063
Product ID 43063-505_41389c99-6a99-0d1f-e063-6394a90aed19
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ZALEPLON
Dosage form CAPSULE
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA078829
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 A078829-001 ZALEPLON ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 A078829-002 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 A078829-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078829-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078829-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078829-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078829-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078829-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078829-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078829-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078829-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078829-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078829-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078829-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078829-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078829-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078829-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078829-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078829-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078829-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078829-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078829-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078829-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078829-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078829-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078829-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078829-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078829-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078829-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078829-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078829-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078829-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078829-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078829-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078829-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078829-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078829-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078829-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078829-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A078829-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078829-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A078829-002 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 43063-505-30 ZALEPLON 30 in 1 BOTTLE, PLASTIC CAPSULE 30 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ZALEPLON ACTIVE INGREDIENT S62U433RMH ZALEPLON CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 ZALEPLON ACTIVE MOIETY S62U433RMH ZALEPLON CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ZALEPLON CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ZALEPLON CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 FD&C GREEN NO. 3 INACTIVE INGREDIENT 3P3ONR6O1S ZALEPLON CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 FD&C YELLOW NO. 5 INACTIVE INGREDIENT I753WB2F1M ZALEPLON CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 ZALEPLON CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 GELATIN INACTIVE INGREDIENT 2G86QN327L ZALEPLON CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ZALEPLON CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 SHELLAC INACTIVE INGREDIENT 46N107B71O ZALEPLON CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ZALEPLON CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J ZALEPLON CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ZALEPLON CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP ZALEPLON CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ZALEPLON CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43063-505 ZALEPLON CAPSULE [PD-RX PHARMACEUTICALS, INC.] 14 Current NDC, Legacy NDC, 1 package rows 20240809_9c83b71e-8344-4c77-b7f6-a9c862f9e7dd.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ZALEPLON ZALEPLON PD-Rx Pharmaceuticals, Inc. 9c83b71e-8344-4c77-b7f6-a9c862f9e7dd 2025-10-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078829 application number: ANDA078829 ndc (package): 43063-505-30 ndc (product): 43063-505 ndc11 (package): 43063050530 ZALEPLON ZALEPLON Bryant Ranch Prepack bec67c5d-9f8f-4490-a0b4-9b7905b565f1 2024-05-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078829 application number: ANDA078829 ZALEPLON ZALEPLON Rising Pharma Holdings, Inc. cff46def-c452-49bb-abea-480de8f432bd 2024-05-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078829 application number: ANDA078829 ZALEPLON ZALEPLON Aurobindo Pharma Limited e092f3ca-bf44-4568-a72c-3fb2cf5b192b 2024-05-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078829 application number: ANDA078829
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 43063-505-30 43063050530 30 CAPSULE in 1 BOTTLE, PLASTIC (43063-505-30) 30 capsule 2013-05-17 0000-00-00 No No Current