Home NDC 65862-215 ZALEPLON
Product NDC 65862-215
11-digit product format 658620215
Labeler code 65862
Product ID 65862-215_36ab371f-c2fe-4c1d-ad60-801b8f118f4e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ZALEPLON
Dosage form CAPSULE
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA078829
Marketing category ANDA
Marketing start 2008-06-06
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 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 · 2 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 65862-215 UNFINISHED Active or certified unfinished drug listing 2026-08-12 unfinished package package 65862-215 65862-215-26 UNFINISHED Active or certified unfinished drug listing 2026-08-12
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 1 · 42 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 21:27 UTC · source 2025-12-05 unfinished product product a6255e0c9aa5…a0211a219f2e…2025-12-14 21:27 UTC · source 2025-12-05 unfinished package package 65862-215-26 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 unfinished product product 1d862106b807…00c93037cd84…2025-08-26 23:59 UTC · source 2025-08-26 unfinished package package 65862-215-26 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 unfinished product product 390b4c401c3f…2c692c2daee3…2025-05-15 14:59 UTC · source 2025-05-14 unfinished package package 65862-215-26 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 unfinished product product e30019b0c005…a3f0b14938b7…2025-04-01 07:37 UTC · source 2025-03-31 unfinished package package 65862-215-26 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 unfinished product product bbbc9f937eca…946b9c97cf81…2025-03-01 13:19 UTC · source 2025-02-28 unfinished package package 65862-215-26 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 unfinished product product f268b84574a6…26285f5ac5df…2025-02-27 05:24 UTC · source 2025-02-26 unfinished package package 65862-215-26 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 unfinished product product f764e8902f78…92046438deef…2025-02-01 13:13 UTC · source 2025-01-31 unfinished package package 65862-215-26 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 unfinished product product 68b1e3bced9e…98a755eb8bc6…2025-01-20 13:05 UTC · source 2025-01-17 unfinished package package 65862-215-26 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 unfinished product product 05c55d027831…ca05dca9dc4c…2024-11-29 20:42 UTC · source 2024-11-29 unfinished package package 65862-215-26 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 unfinished product product 48b4f40e6753…c7c7a00d2afa…2024-11-09 02:36 UTC · source 2024-11-08 unfinished package package 65862-215-26 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 unfinished product product 27f29a85d7e4…1372111e901f…2024-10-09 02:27 UTC · source 2024-10-08 unfinished package package 65862-215-26 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 unfinished product product 8d62ce987f31…9fe9ef23e30d…2024-07-10 04:00 UTC · source 2024-07-09 unfinished package package 65862-215-26 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished product product d1e113ab4d42…063ee3eb0a1d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished package package 65862-215-26 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 unfinished product product 50b4072663b7…eae3003ed65e…2024-05-15 03:51 UTC · source 2024-05-14 unfinished package package 65862-215-26 50b4072663b7…eae3003ed65e…2022-04-09 23:13 UTC · source 2022-04-08 unfinished product product 906f6e251498…bf70b80e44f0…2022-04-09 23:13 UTC · source 2022-04-08 unfinished package package 65862-215-26 906f6e251498…bf70b80e44f0…2021-12-27 23:28 UTC · source 2021-12-27 unfinished product product 6db9cb8d1e19…3449e1ec5b70…2021-12-27 23:28 UTC · source 2021-12-27 unfinished package package 65862-215-26 6db9cb8d1e19…3449e1ec5b70…2021-02-18 23:40 UTC · source 2021-02-18 unfinished product product 8fc7167e32ce…e96bbc724034…2021-02-18 23:40 UTC · source 2021-02-18 unfinished package package 65862-215-26 8fc7167e32ce…e96bbc724034…2020-12-18 03:04 UTC · source 2020-12-17 unfinished product product 4184dd79f89f…545327b3e20f…2020-12-18 03:04 UTC · source 2020-12-17 unfinished package package 65862-215-26 4184dd79f89f…545327b3e20f…2020-06-10 20:45 UTC · source 2020-06-10 unfinished product product 4bd3596a7b87…5c64c6f6865f…2020-06-10 20:45 UTC · source 2020-06-10 unfinished package package 65862-215-26 4bd3596a7b87…5c64c6f6865f…2019-12-08 06:16 UTC · source 2019-12-05 unfinished product product 263afe128892…91768de4ddbe…2019-12-08 06:16 UTC · source 2019-12-05 unfinished package package 65862-215-26 263afe128892…91768de4ddbe…2019-06-01 22:24 UTC · source 2019-05-30 unfinished product product 5b2001dcd8f5…54b53d4dc9e4…2019-06-01 22:24 UTC · source 2019-05-30 unfinished package package 65862-215-26 5b2001dcd8f5…54b53d4dc9e4…
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 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 · 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 65862-215-01 ZALEPLON 100 in 1 BOTTLE CAPSULE 100 11 65862-215-05 ZALEPLON 500 in 1 BOTTLE CAPSULE 500 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ZALEPLON ACTIVE INGREDIENT S62U433RMH ZALEPLON CAPSULE [AUROBINDO PHARMA LIMITED] 7 ZALEPLON ACTIVE MOIETY S62U433RMH ZALEPLON CAPSULE [AUROBINDO PHARMA LIMITED] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ZALEPLON CAPSULE [AUROBINDO PHARMA LIMITED] 7 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ZALEPLON CAPSULE [AUROBINDO PHARMA LIMITED] 7 FD&C GREEN NO. 3 INACTIVE INGREDIENT 3P3ONR6O1S ZALEPLON CAPSULE [AUROBINDO PHARMA LIMITED] 7 FD&C YELLOW NO. 5 INACTIVE INGREDIENT I753WB2F1M ZALEPLON CAPSULE [AUROBINDO PHARMA LIMITED] 7 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 ZALEPLON CAPSULE [AUROBINDO PHARMA LIMITED] 7 GELATIN INACTIVE INGREDIENT 2G86QN327L ZALEPLON CAPSULE [AUROBINDO PHARMA LIMITED] 7 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ZALEPLON CAPSULE [AUROBINDO PHARMA LIMITED] 7 SHELLAC INACTIVE INGREDIENT 46N107B71O ZALEPLON CAPSULE [AUROBINDO PHARMA LIMITED] 7 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ZALEPLON CAPSULE [AUROBINDO PHARMA LIMITED] 7 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J ZALEPLON CAPSULE [AUROBINDO PHARMA LIMITED] 7 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ZALEPLON CAPSULE [AUROBINDO PHARMA LIMITED] 7 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP ZALEPLON CAPSULE [AUROBINDO PHARMA LIMITED] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ZALEPLON CAPSULE [AUROBINDO PHARMA LIMITED] 7 ZALEPLON ACTIVE INGREDIENT S62U433RMH ZALEPLON CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 ZALEPLON ACTIVE MOIETY S62U433RMH ZALEPLON CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ZALEPLON CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ZALEPLON CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 FD&C GREEN NO. 3 INACTIVE INGREDIENT 3P3ONR6O1S ZALEPLON CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 FD&C YELLOW NO. 5 INACTIVE INGREDIENT I753WB2F1M ZALEPLON CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 ZALEPLON CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L ZALEPLON CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ZALEPLON CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O ZALEPLON CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ZALEPLON CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J ZALEPLON CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ZALEPLON CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP ZALEPLON CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ZALEPLON CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-215 ZALEPLON CAPSULE [AUROBINDO PHARMA LIMITED] 11 Current NDC, Legacy NDC, 2 package rows 20240510_e092f3ca-bf44-4568-a72c-3fb2cf5b192b.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 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 ndc (product): 65862-215
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 65862-215-01 65862021501 100 CAPSULE in 1 BOTTLE (65862-215-01) 100 capsule 2008-06-06 0000-00-00 No No Current 65862-215-05 65862021505 500 CAPSULE in 1 BOTTLE (65862-215-05) 500 capsule 2008-06-06 0000-00-00 No No Current 65862-215-26 65862021526 2500 CAPSULE in 1 BAG (65862-215-26) 2500 capsule 06-JUN-08 Current