FDA.reportPublic FDA data

Zolpidem Tartrate

Product NDC
13668-775
Requested package NDC
13668-775-30
11-digit product format
136680775
Labeler code
13668
Product ID
13668-775_56a1fe3a-0093-6ab8-e063-6294a90a6995
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
CAPSULE
Route
ORAL
Labeler
TORRENT PHARMACEUTICALS LIMITED
Application
ANDA220717
Marketing category
ANDA
Marketing start
2026-06-23
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 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A220717-001ZOLPIDEM TARTRATEZOLPIDEM TARTRATE7.5MGCAPSULE / ORALAB2026-05-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A220717-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A220717-001ZOLPIDEM TARTRATE7.5MGCAPSULE / ORALAB2026-05-1284e616aacf4f…
2026-08-18 06:07:402026-07A220717-001ZOLPIDEM TARTRATE7.5MGCAPSULE / ORALAB2026-05-12caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220717-001ZOLPIDEM TARTRATE7.5MGCAPSULE / ORALAB2026-05-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A220717-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A220717-001AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220717-001AB1a50c72e98297…

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
IngredientStrength
ZOLPIDEM TARTRATE7.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WY6W63843KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2637353Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9025a6f7-5501-4aba-875e-222ef39848c0Available on FDA.report

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zolpidem TartrateZOLPIDEM TARTRATETORRENT PHARMACEUTICALS LIMITED9025a6f7-5501-4aba-875e-222ef39848c02026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 220717
application number: ANDA220717
ndc (package): 13668-775-30
ndc (product): 13668-775
ndc11 (package): 13668077530
Zolpidem TartrateZOLPIDEM TARTRATEUmedica Laboratories USA Inc.b49f6c18-e155-4728-a79a-9354e8c3c8f42026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 220717
application number: ANDA220717

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
13668-775-301366807753030 CAPSULE in 1 BOTTLE (13668-775-30) 30 capsule2026-06-23NoNoCurrent