Home NDC 60290-089-02 Zolpidem Tartrate
Product NDC 60290-089
Requested package NDC 60290-089-02
11-digit product format 602900089
Labeler code 60290
Product ID 60290-089_5e7d4f94-4074-bb60-e063-6394a90a064b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Zolpidem Tartrate
Dosage form CAPSULE
Route ORAL
Labeler Umedica Laboratories USA Inc.
Application ANDA220717
Marketing category ANDA
Marketing start 2026-05-14
Substance ZOLPIDEM TARTRATE
Active strength 7.5 mg/1
Pharmacologic classes Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]
DEA schedule CIV
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A220717-001 ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 7.5MG CAPSULE / ORAL AB 2026-05-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A220717-001 AB
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.
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 2026-10-15 13:18:30 2026-09 A220717-001 ZOLPIDEM TARTRATE 7.5MG CAPSULE / ORAL AB 2026-05-12 c2088c7a36db…2026-09-14 22:38:34 2026-08 A220717-001 ZOLPIDEM TARTRATE 7.5MG CAPSULE / ORAL AB 2026-05-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 A220717-001 ZOLPIDEM TARTRATE 7.5MG CAPSULE / ORAL AB 2026-05-12 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220717-001 ZOLPIDEM TARTRATE 7.5MG CAPSULE / ORAL AB 2026-05-12 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Zolpidem Tartrate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZOLPIDEM TARTRATE 7.5 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2637353 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 60290-089-01 Zolpidem Tartrate 30 in 1 BOTTLE CAPSULE 30 2 60290-089-02 Zolpidem Tartrate 1000 in 1 BOTTLE CAPSULE 1000 2
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 60290-089-02 60290008902 1000 CAPSULE in 1 BOTTLE (60290-089-02) 1000 capsule 2026-05-14 No No Current