Home NDC 43386-761 ZOLPIDEM TARTRATE
Product NDC 43386-761
11-digit product format 433860761
Labeler code 43386
Product ID 43386-761_b4684db4-fae2-5bc4-e053-2995a90a9cd1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name zolpidem tartrate
Dosage form TABLET
Route SUBLINGUAL
Labeler Lupin Pharmaceuticals,Inc.
Application ANDA204299
Marketing category ANDA
Marketing start 2016-03-22
Substance ZOLPIDEM TARTRATE
Active strength 3.5 mg/1
Pharmacologic classes Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic 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 A204299-001 ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 A204299-002 ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03
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 A204299-001 ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204299-002 ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204299-001 ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204299-002 ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204299-001 ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204299-002 ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204299-001 ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204299-002 ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204299-001 ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204299-002 ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204299-001 ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204299-002 ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204299-001 ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204299-002 ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204299-001 ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204299-002 ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204299-001 ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204299-002 ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204299-001 ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204299-002 ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204299-001 ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204299-002 ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204299-001 ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204299-002 ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204299-001 ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204299-002 ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204299-001 ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A204299-002 ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204299-001 ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204299-002 ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204299-001 ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A204299-002 ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204299-001 ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A204299-002 ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204299-001 ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A204299-002 ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204299-001 ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A204299-002 ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204299-001 ZOLPIDEM TARTRATE 1.75MG TABLET / SUBLINGUAL AB 2015-06-03 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A204299-002 ZOLPIDEM TARTRATE 3.5MG TABLET / SUBLINGUAL AB RS 2015-06-03 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 ZOLPIDEM TARTRATE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZOLPIDEM TARTRATE 3.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WY6W63843K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1232194 Internal RxNorm lookup 1232202 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 43386-761-01 ZOLPIDEM TARTRATE 1 in 1 BLISTER PACK TABLET 1 6 43386-761-01 ZOLPIDEM TARTRATE 1 in 1 POUCH TABLET 1 6 43386-761-30 ZOLPIDEM TARTRATE 30 in 1 CARTON TABLET 30 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43386-761 ZOLPIDEM TARTRATE TABLET [LUPIN PHARMACEUTICALS,INC.] 6 Current NDC, Legacy NDC, 3 package rows 20201119_6db679f6-b1f8-4fbf-9e87-9cef4650c45a.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 · 1 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 43386-761-01 43386076101 1 in 1 BLISTER PACK Historical 43386-761-30 43386076130 30 POUCH in 1 CARTON (43386-761-30) / 1 BLISTER PACK in 1 POUCH (43386-761-01) / 1 TABLET in 1 BLISTER PACK 30 pouch 2016-03-22 0000-00-00 No No Current