ZOLPIDEM TARTRATE

Product NDC
13668-007
11-digit product format
136680007
Labeler code
13668
Product ID
13668-007_783b6c2c-bec3-44db-b758-d762377a34ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA077903
Marketing category
ANDA
Marketing start
2007-09-05
Substance
ZOLPIDEM TARTRATE
Active strength
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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077903-001ZOLPIDEM TARTRATEZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-17
A077903-002ZOLPIDEM TARTRATEZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A077903-001AB
A077903-002AB

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077903-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-17caaa826d4ba7…
2026-08-18 06:07:402026-07A077903-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077903-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077903-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077903-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077903-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A077903-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077903-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077903-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077903-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077903-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077903-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077903-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077903-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077903-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077903-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077903-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077903-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077903-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077903-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077903-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A077903-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077903-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077903-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077903-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077903-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077903-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077903-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077903-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-178072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077903-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077903-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077903-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077903-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077903-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077903-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-174b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077903-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077903-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-1774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077903-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077903-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-08-17bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077903-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-08-17bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A077903-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077903-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077903-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077903-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077903-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077903-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077903-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077903-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077903-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077903-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077903-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077903-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077903-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077903-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077903-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077903-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077903-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077903-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077903-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077903-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077903-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077903-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077903-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077903-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077903-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077903-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077903-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077903-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077903-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077903-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077903-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077903-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077903-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077903-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077903-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077903-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077903-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077903-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077903-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077903-002AB1bb7c543d1eb4…

Additional Listing Data#

Finished product
Yes
Brand name base
ZOLPIDEM TARTRATE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZOLPIDEM TARTRATE5 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
854873Internal RxNorm lookup
854876Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1584bad1-7bf4-4805-bdd9-7eb0fac92721Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75543837-e611-4401-8337-81e7d5cb9b04Product name120231011
f40c5cae-52e4-45d3-95e3-8ba7f79e50e4Product name320201208
70793b8c-c4d9-ddb4-5f8a-4308eb0087a2Product name420171109
3970acdc-9e18-4f3d-165e-245802aafc57Product name220160829
438b1497-0992-6caa-062f-3853a7f9e4b1Product name120140508
813c8976-a1f1-3a35-1a71-1557bfb59446Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13668-007-01ZOLPIDEM TARTRATE100 in 1 BOTTLETABLET10024
13668-007-05ZOLPIDEM TARTRATE500 in 1 BOTTLETABLET50024
13668-007-10ZOLPIDEM TARTRATE1000 in 1 BOTTLETABLET100024
13668-007-15ZOLPIDEM TARTRATE1500 in 1 BOTTLETABLET150024
13668-007-30ZOLPIDEM TARTRATE30 in 1 BOTTLETABLET3024
13668-007-90ZOLPIDEM TARTRATE90 in 1 BOTTLETABLET9024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-007-01EA - Each13668-007e0449be7-92fa-451c-b00a-a7cf32d5aa9712012-07-24
13668-007-05EA - Each13668-007a2e07bc3-3dd0-4291-8d0f-92f0680c1b3012012-07-24
13668-007-10EA - Each13668-007cc9c20f9-5c6c-4ab6-9ff3-ac3739749cf312012-07-24
13668-007-15EA - Each13668-00750d070e0-484f-469c-a7f3-0b829dd72eab12012-07-24
13668-007-30EA - Each13668-0075d42478e-fee7-414e-be0a-34d93082d0de12012-07-24
13668-007-74EA - Each13668-0073b03a506-0e35-43f2-a48f-3f26ce70166f12012-07-24
13668-007-90EA - Each13668-007022e8edf-cd69-41fc-8733-267c3bc4e48612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET [TORRENT PHARMACEUTICALS LIMITED]9
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET [MAJOR PHARMACEUTICALS]9
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET [TORRENT PHARMACEUTICALS LIMITED]9
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET [MAJOR PHARMACEUTICALS]9
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZOLPIDEM TARTRATE TABLET [MAJOR PHARMACEUTICALS]9
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZOLPIDEM TARTRATE TABLET [TORRENT PHARMACEUTICALS LIMITED]9
CHOLINEACTIVE INGREDIENTN91BDP6H0XGABAZOLPIDEM-5 (ZOLPIDEM TARTRATE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]7
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KGABAZOLPIDEM-5 (ZOLPIDEM TARTRATE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]7
CHOLINEACTIVE MOIETYN91BDP6H0XGABAZOLPIDEM-5 (ZOLPIDEM TARTRATE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]7
ZOLPIDEMACTIVE MOIETY7K383OQI23GABAZOLPIDEM-5 (ZOLPIDEM TARTRATE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGABAZOLPIDEM-5 (ZOLPIDEM TARTRATE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]7
GELATININACTIVE INGREDIENT2G86QN327LGABAZOLPIDEM-5 (ZOLPIDEM TARTRATE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAZOLPIDEM-5 (ZOLPIDEM TARTRATE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]7
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DGABAZOLPIDEM-5 (ZOLPIDEM TARTRATE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]7
CHOLINEACTIVE INGREDIENTN91BDP6H0XSENTRAZOLPIDEM PM-5 (ZOLPIDEM TARTRATE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]6
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KSENTRAZOLPIDEM PM-5 (ZOLPIDEM TARTRATE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]6
CHOLINEACTIVE MOIETYN91BDP6H0XSENTRAZOLPIDEM PM-5 (ZOLPIDEM TARTRATE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]6
ZOLPIDEMACTIVE MOIETY7K383OQI23SENTRAZOLPIDEM PM-5 (ZOLPIDEM TARTRATE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USENTRAZOLPIDEM PM-5 (ZOLPIDEM TARTRATE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]6
GELATININACTIVE INGREDIENT2G86QN327LSENTRAZOLPIDEM PM-5 (ZOLPIDEM TARTRATE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SENTRAZOLPIDEM PM-5 (ZOLPIDEM TARTRATE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]6
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DSENTRAZOLPIDEM PM-5 (ZOLPIDEM TARTRATE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]6
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET [REDPHARM DRUG INC.]5
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET [REDPHARM DRUG INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZOLPIDEM TARTRATE TABLET [REDPHARM DRUG INC.]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZOLPIDEM TARTRATE TABLET [REDPHARM DRUG INC.]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZOLPIDEM TARTRATE TABLET [REDPHARM DRUG INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XZOLPIDEM TARTRATE TABLET [REDPHARM DRUG INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZOLPIDEM TARTRATE TABLET [REDPHARM DRUG INC.]5
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AZOLPIDEM TARTRATE TABLET [REDPHARM DRUG INC.]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZOLPIDEM TARTRATE TABLET [REDPHARM DRUG INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZOLPIDEM TARTRATE TABLET [REDPHARM DRUG INC.]5
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET [ST MARYS MEDICAL PARK PHARMACY]4
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET [ST MARYS MEDICAL PARK PHARMACY]4
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET [BRYANT RANCH PREPACK]3
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET [BRYANT RANCH PREPACK]3
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZOLPIDEM TARTRATE TABLET [BRYANT RANCH PREPACK]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZOLPIDEM TARTRATE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZOLPIDEM TARTRATE TABLET [BRYANT RANCH PREPACK]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XZOLPIDEM TARTRATE TABLET [BRYANT RANCH PREPACK]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZOLPIDEM TARTRATE TABLET [BRYANT RANCH PREPACK]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AZOLPIDEM TARTRATE TABLET [BRYANT RANCH PREPACK]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZOLPIDEM TARTRATE TABLET [BRYANT RANCH PREPACK]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZOLPIDEM TARTRATE TABLET [BRYANT RANCH PREPACK]3
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET [STAT RX USA LLC]2
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET [DIRECTRX]2
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET [STAT RX USA LLC]2
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET [DIRECTRX]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZOLPIDEM TARTRATE TABLET [STAT RX USA LLC]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZOLPIDEM TARTRATE TABLET [DIRECTRX]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZOLPIDEM TARTRATE TABLET [STAT RX USA LLC]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTZOLPIDEM TARTRATE TABLET [STAT RX USA LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZOLPIDEM TARTRATE TABLET [STAT RX USA LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XZOLPIDEM TARTRATE TABLET [STAT RX USA LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZOLPIDEM TARTRATE TABLET [STAT RX USA LLC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AZOLPIDEM TARTRATE TABLET [STAT RX USA LLC]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZOLPIDEM TARTRATE TABLET [STAT RX USA LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZOLPIDEM TARTRATE TABLET [STAT RX USA LLC]2
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET [RXCHANGE CO.]1
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET [RXCHANGE CO.]1
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET [PROFICIENT RX LP]1
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET [A-S MEDICATION SOLUTIONS LLC]1
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET [REBEL DISTRIBUTORS CORP.]1
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET [PROFICIENT RX LP]1
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET [RXCHANGE CO.]1
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET [REBEL DISTRIBUTORS CORP.]1
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET [A-S MEDICATION SOLUTIONS LLC]1
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET [RXCHANGE CO.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZOLPIDEM TARTRATE TABLET [RXCHANGE CO.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZOLPIDEM TARTRATE TABLET [A-S MEDICATION SOLUTIONS LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZOLPIDEM TARTRATE TABLET [RXCHANGE CO.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZOLPIDEM TARTRATE TABLET [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-007ZOLPIDEM TARTRATE TABLET [TORRENT PHARMACEUTICALS LIMITED]24Current NDC, Legacy NDC, 6 package rows20240808_1584bad1-7bf4-4805-bdd9-7eb0fac92721.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 2 · 29 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEBryant Ranch Prepack413b6f65-101e-e2cf-0802-711d080b851b2026-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077903
application number: ANDA077903
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEREMEDYREPACK INC.2abdcf77-d3ed-42bc-acd9-545aab75d5672026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077903
application number: ANDA077903
ZOLPIDEM TARTRATEZOLPIDEM TARTRATESt. Mary's Medical Park Pharmacy507225e2-80ba-18c4-e054-00144ff88e882026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077903
application number: ANDA077903
ZOLPIDEM TARTRATEZOLPIDEM TARTRATETorrent Pharmaceuticals Limited1584bad1-7bf4-4805-bdd9-7eb0fac927212026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077903
application number: ANDA077903
ndc (product): 13668-007
ZOLPIDEM TARTRATEZOLPIDEM TARTRATESt. Mary's Medical Park Pharmacy89cfb1d5-437c-4c13-8f9b-b6851ffba87b2026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077903
application number: ANDA077903
ZOLPIDEM TARTRATEZOLPIDEM TARTRATECalvin Scott & Co., Inc.7da75d2b-905c-4fdf-bc53-1358c64777552026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077903
application number: ANDA077903
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEA-S Medication Solutions59cc61da-838e-4add-b2d6-42b2b283a0002026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077903
application number: ANDA077903
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEDirect_Rx907c7b18-2638-512c-e053-2995a90ae6fd2026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077903
application number: ANDA077903
ZOLPIDEM TARTRATEZOLPIDEM TARTRATENorthwind Health Company, LLC26e20f53-c042-eac0-e063-6394a90acfca2025-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077903
application number: ANDA077903
ZOLPIDEM TARTRATEZOLPIDEM TARTRATECardinal Health 107, LLC83510333-f07d-4b81-a3ae-2801d114bd312025-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077903
application number: ANDA077903
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEPreferred Pharmaceuticals, Inc.a9ac3d4e-f502-41e3-95c0-0d334584566d2025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077903
application number: ANDA077903
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEMajor Pharmaceuticalsd34336b1-7041-4078-beda-94bc9d9f771e2025-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077903
application number: ANDA077903
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEAsclemed USA, Inc.e5e2d31b-ce26-78b0-e053-2a95a90ac4912025-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077903
application number: ANDA077903
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx of Tennessee, LLCaf87ae17-a3c5-a3a5-e053-2a95a90aa4b02024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077903
application number: ANDA077903
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx Pharmacy of Tennessee, LLCc8adec28-9dcd-4a7e-e053-2a95a90a991e2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077903
application number: ANDA077903
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx Pharmacy of Tennessee, LLCfc76ab4c-3607-39c3-e053-6394a90a68772024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077903
application number: ANDA077903
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx Pharmacy of Tennessee, LLCf939549f-14a6-d37c-e053-6294a90a034a2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077903
application number: ANDA077903
ZOLPIDEM TARTRATEZOLPIDEM TARTRATELake Erie Medical DBA Quality Care Products LLCdb735db9-1c82-4d32-bf91-97b05a75e8762024-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077903
application number: ANDA077903
ZOLPIDEM TARTRATEZOLPIDEM TARTRATENuCare Pharmaceuticals,Inc.95b0ba48-4e71-25f7-e053-2a95a90aea822024-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077903
application number: ANDA077903
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEBryant Ranch Prepack3bbc3c35-2811-4a67-9dcc-5eed38ef8b522024-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077903
application number: ANDA077903

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854876zolpidem tartrate 5 MG Oral TabletPSN59cc61da-838e-4add-b2d6-42b2b283a00033
854876zolpidem tartrate 5 MG Oral TabletSCD59cc61da-838e-4add-b2d6-42b2b283a00033
854873zolpidem tartrate 10 MG Oral TabletPSN1584bad1-7bf4-4805-bdd9-7eb0fac9272124
854876zolpidem tartrate 5 MG Oral TabletPSN1584bad1-7bf4-4805-bdd9-7eb0fac9272124
854873zolpidem tartrate 10 MG Oral TabletSCD1584bad1-7bf4-4805-bdd9-7eb0fac9272124
854876zolpidem tartrate 5 MG Oral TabletSCD1584bad1-7bf4-4805-bdd9-7eb0fac9272124
854873zolpidem tartrate 10 MG Oral TabletPSNd34336b1-7041-4078-beda-94bc9d9f771e19
854876zolpidem tartrate 5 MG Oral TabletPSNd34336b1-7041-4078-beda-94bc9d9f771e19
854873zolpidem tartrate 10 MG Oral TabletSCDd34336b1-7041-4078-beda-94bc9d9f771e19
854876zolpidem tartrate 5 MG Oral TabletSCDd34336b1-7041-4078-beda-94bc9d9f771e19
854876zolpidem tartrate 5 MG Oral TabletPSN413b6f65-101e-e2cf-0802-711d080b851b16
854876zolpidem tartrate 5 MG Oral TabletSCD413b6f65-101e-e2cf-0802-711d080b851b16
854873zolpidem tartrate 10 MG Oral TabletPSNa9ac3d4e-f502-41e3-95c0-0d334584566d12
854876zolpidem tartrate 5 MG Oral TabletPSN89cfb1d5-437c-4c13-8f9b-b6851ffba87b12
854876zolpidem tartrate 5 MG Oral TabletPSNa9ac3d4e-f502-41e3-95c0-0d334584566d12
854873zolpidem tartrate 10 MG Oral TabletSCDa9ac3d4e-f502-41e3-95c0-0d334584566d12
854876zolpidem tartrate 5 MG Oral TabletSCD89cfb1d5-437c-4c13-8f9b-b6851ffba87b12
854876zolpidem tartrate 5 MG Oral TabletSCDa9ac3d4e-f502-41e3-95c0-0d334584566d12
854876zolpidem tartrate 5 MG Oral TabletPSNc4d6413d-e02a-68cc-e053-2a95a90a8a7411
854876zolpidem tartrate 5 MG Oral TabletSCDc4d6413d-e02a-68cc-e053-2a95a90a8a7411
854873zolpidem tartrate 10 MG Oral TabletPSN1211fbc0-7b2a-4bd0-8be4-9fdcc0553aee8
854876zolpidem tartrate 5 MG Oral TabletPSN1211fbc0-7b2a-4bd0-8be4-9fdcc0553aee8
854873zolpidem tartrate 10 MG Oral TabletSCD1211fbc0-7b2a-4bd0-8be4-9fdcc0553aee8
854876zolpidem tartrate 5 MG Oral TabletSCD1211fbc0-7b2a-4bd0-8be4-9fdcc0553aee8
854873zolpidem tartrate 10 MG Oral TabletPSN96d08f88-c841-46d6-958d-7f45656e672c7
854876zolpidem tartrate 5 MG Oral TabletPSN96d08f88-c841-46d6-958d-7f45656e672c7
854876zolpidem tartrate 5 MG Oral TabletPSNd31076b4-44ac-4f8b-8df6-5200cdbea12b7
854873zolpidem tartrate 10 MG Oral TabletSCD96d08f88-c841-46d6-958d-7f45656e672c7
854876zolpidem tartrate 5 MG Oral TabletSCD96d08f88-c841-46d6-958d-7f45656e672c7
854876zolpidem tartrate 5 MG Oral TabletSCDd31076b4-44ac-4f8b-8df6-5200cdbea12b7
854876zolpidem tartrate 5 MG Oral TabletPSNc8adec28-9dcd-4a7e-e053-2a95a90a991e6
854876zolpidem tartrate 5 MG Oral TabletPSNc154b9c7-4cce-4ae0-8cff-d3de1273062e6
854876zolpidem tartrate 5 MG Oral TabletPSN2abdcf77-d3ed-42bc-acd9-545aab75d5676
854876zolpidem tartrate 5 MG Oral TabletPSN54101870-d8a8-4b35-a31d-93480af9d1816
854876zolpidem tartrate 5 MG Oral TabletSCD54101870-d8a8-4b35-a31d-93480af9d1816
854876zolpidem tartrate 5 MG Oral TabletSCDc154b9c7-4cce-4ae0-8cff-d3de1273062e6
854876zolpidem tartrate 5 MG Oral TabletSCDc8adec28-9dcd-4a7e-e053-2a95a90a991e6
854876zolpidem tartrate 5 MG Oral TabletSCD2abdcf77-d3ed-42bc-acd9-545aab75d5676
854876zolpidem tartrate 5 MG Oral TabletPSN907c7b18-2638-512c-e053-2995a90ae6fd5
854876zolpidem tartrate 5 MG Oral TabletPSN8a0a454e-b18e-4d89-bf16-943c4c968fe25
854876zolpidem tartrate 5 MG Oral TabletPSN78481108-4a1c-fce9-e053-2a91aa0a09ad5
854876zolpidem tartrate 5 MG Oral TabletPSNe1f43bde-efba-42be-adef-94e1ef6664fd5
854876zolpidem tartrate 5 MG Oral TabletSCD907c7b18-2638-512c-e053-2995a90ae6fd5
854876zolpidem tartrate 5 MG Oral TabletSCD8a0a454e-b18e-4d89-bf16-943c4c968fe25
854876zolpidem tartrate 5 MG Oral TabletSCD78481108-4a1c-fce9-e053-2a91aa0a09ad5
854876zolpidem tartrate 5 MG Oral TabletSCDe1f43bde-efba-42be-adef-94e1ef6664fd5
854873zolpidem tartrate 10 MG Oral TabletPSNc0543e05-3220-4a8a-abd9-6a73c42848c23
854876zolpidem tartrate 5 MG Oral TabletPSNc0543e05-3220-4a8a-abd9-6a73c42848c23
854876zolpidem tartrate 5 MG Oral TabletPSNac8c412a-0f94-7c3a-e053-2995a90afdc73
854873zolpidem tartrate 10 MG Oral TabletSCDc0543e05-3220-4a8a-abd9-6a73c42848c23
854876zolpidem tartrate 5 MG Oral TabletSCDac8c412a-0f94-7c3a-e053-2995a90afdc73
854876zolpidem tartrate 5 MG Oral TabletSCDc0543e05-3220-4a8a-abd9-6a73c42848c23
854873zolpidem tartrate 10 MG Oral TabletPSNe5e2d31b-ce26-78b0-e053-2a95a90ac4912
854873zolpidem tartrate 10 MG Oral TabletPSNb87ea23e-2d54-4d10-8f10-72d4c62f32452
854876zolpidem tartrate 5 MG Oral TabletPSNe5e2d31b-ce26-78b0-e053-2a95a90ac4912
854876zolpidem tartrate 5 MG Oral TabletPSNf939549f-14a6-d37c-e053-6294a90a034a2
854876zolpidem tartrate 5 MG Oral TabletPSN68062bb7-ef75-4540-b6c0-26bc57a80f672
854876zolpidem tartrate 5 MG Oral TabletPSNb87ea23e-2d54-4d10-8f10-72d4c62f32452
854873zolpidem tartrate 10 MG Oral TabletSCDb87ea23e-2d54-4d10-8f10-72d4c62f32452
854873zolpidem tartrate 10 MG Oral TabletSCDe5e2d31b-ce26-78b0-e053-2a95a90ac4912
854876zolpidem tartrate 5 MG Oral TabletSCD68062bb7-ef75-4540-b6c0-26bc57a80f672
854876zolpidem tartrate 5 MG Oral TabletSCDf939549f-14a6-d37c-e053-6294a90a034a2
854876zolpidem tartrate 5 MG Oral TabletSCDe5e2d31b-ce26-78b0-e053-2a95a90ac4912
854876zolpidem tartrate 5 MG Oral TabletSCDb87ea23e-2d54-4d10-8f10-72d4c62f32452
854873zolpidem tartrate 10 MG Oral TabletPSN7efb19d9-32bb-4737-ac7f-2ec21eca255c1
854873zolpidem tartrate 10 MG Oral TabletPSN503b8e97-1fd1-4b29-a9b7-7fb87727fe4e1
854873zolpidem tartrate 10 MG Oral TabletPSN06a454bc-50d0-45de-87db-f3e3502e3bb01
854876zolpidem tartrate 5 MG Oral TabletPSN7efb19d9-32bb-4737-ac7f-2ec21eca255c1
854876zolpidem tartrate 5 MG Oral TabletPSN72046304-31ef-9043-e053-2995a90a57ea1
854876zolpidem tartrate 5 MG Oral TabletPSN06a454bc-50d0-45de-87db-f3e3502e3bb01
854876zolpidem tartrate 5 MG Oral TabletPSNb1a74192-3f4b-4e08-b6cd-19cefa0125e61
854873zolpidem tartrate 10 MG Oral TabletSCD7efb19d9-32bb-4737-ac7f-2ec21eca255c1
854873zolpidem tartrate 10 MG Oral TabletSCD503b8e97-1fd1-4b29-a9b7-7fb87727fe4e1
854873zolpidem tartrate 10 MG Oral TabletSCD06a454bc-50d0-45de-87db-f3e3502e3bb01
854876zolpidem tartrate 5 MG Oral TabletSCD7efb19d9-32bb-4737-ac7f-2ec21eca255c1
854876zolpidem tartrate 5 MG Oral TabletSCD72046304-31ef-9043-e053-2995a90a57ea1
854876zolpidem tartrate 5 MG Oral TabletSCDb1a74192-3f4b-4e08-b6cd-19cefa0125e61
854876zolpidem tartrate 5 MG Oral TabletSCD06a454bc-50d0-45de-87db-f3e3502e3bb01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-007-0113668000701100 TABLET in 1 BOTTLE (13668-007-01) 100 tablet2007-09-050000-00-00NoNoCurrent
13668-007-0513668000705500 TABLET in 1 BOTTLE (13668-007-05) 500 tablet2007-09-050000-00-00NoNoCurrent
13668-007-10136680007101000 TABLET in 1 BOTTLE (13668-007-10) 1000 tablet2007-09-050000-00-00NoNoCurrent
13668-007-15136680007151500 TABLET in 1 BOTTLE (13668-007-15) 1500 tablet2007-09-050000-00-00NoNoCurrent
13668-007-301366800073030 TABLET in 1 BOTTLE (13668-007-30) 30 tablet2007-09-050000-00-00NoNoCurrent
13668-007-7413668000774100 TABLET in 1 CARTON (13668-007-74) 100 tablet2007-09-050000-00-00NoNoCurrent
13668-007-901366800079090 TABLET in 1 BOTTLE (13668-007-90) 90 tablet2007-09-050000-00-00NoNoCurrent