FDA.reportPublic FDA data

Application 091166

Type
ANDA
Sponsor
GLENMARK GENERICS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESZOPICLONEESZOPICLONETABLET;ORAL1MGNoNo
002ESZOPICLONEESZOPICLONETABLET;ORAL2MGNoNo
003ESZOPICLONEESZOPICLONETABLET;ORAL3MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091166-001ESZOPICLONEESZOPICLONE1MGTABLET / ORALAB2014-04-15
A091166-002ESZOPICLONEESZOPICLONE2MGTABLET / ORALAB2014-04-15
A091166-003ESZOPICLONEESZOPICLONE3MGTABLET / ORALAB2014-04-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A091166-001AB
A091166-002AB
A091166-003AB

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
2026-08-01 22:54:322026-06A091166-001ESZOPICLONE1MGTABLET / ORALAB2014-04-15a50c72e98297…
2026-08-01 22:54:322026-06A091166-002ESZOPICLONE2MGTABLET / ORALAB2014-04-15a50c72e98297…
2026-08-01 22:54:322026-06A091166-003ESZOPICLONE3MGTABLET / ORALAB2014-04-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A091166-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A091166-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A091166-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EszopicloneESZOPICLONESt Mary's Medical Park Pharmacyc4ff1d6a-918e-c046-e053-2a95a90a9c9b2026-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091166
application number: ANDA091166
ndc (product): 60760-526
EszopicloneESZOPICLONEBryant Ranch Prepacke04d4f8b-c9a1-4dc9-aac4-2e6376cd9a0c2026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091166
application number: ANDA091166
ndc (product): 71335-2002
EszopicloneESZOPICLONEPreferred Pharmaceuticals Inc.0102ea59-77b1-4e74-83ec-1d205563b55f2026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091166
application number: ANDA091166
EszopicloneESZOPICLONENuCare Pharmaceuticals,Inc.c24ec179-f869-746f-e053-2995a90aa1ff2026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091166
application number: ANDA091166
ndc (product): 68071-2403
EszopicloneESZOPICLONEAsclemed USA, Inc.838559f7-4b69-4831-bf50-ab37c6c24c2b2026-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091166
application number: ANDA091166
EszopicloneESZOPICLONEGlenmark Pharmaceuticals Inc. USA584dc66c-063a-4552-a056-74b811e2bc802026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091166
application number: ANDA091166
ndc (product): 68462-384
ndc (product): 68462-383
ndc (product): 68462-382
EszopicloneESZOPICLONEBryant Ranch Prepackd1baa5ba-73ac-462b-a728-217d5992674a2024-08-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091166
application number: ANDA091166
ndc (product): 71335-0574
ndc (product): 71335-0512
EszopicloneESZOPICLONEAdvanced Rx of Tennessee, LLC1baa56e5-34d5-c8a1-e063-6394a90ae6c72024-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091166
application number: ANDA091166
EszopicloneESZOPICLONEProficient Rx LPe32746a8-6440-4b0a-a445-4467cf0329d52024-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091166
application number: ANDA091166
EszopicloneESZOPICLONEProficient Rx LPac996f97-fd92-44f8-8bb5-478a81ffb33d2022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091166
application number: ANDA091166
ndc (product): 71205-633
EszopicloneESZOPICLONEProficient Rx LPedc03482-b013-448a-8cd9-2a17bd6d15e92022-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091166
application number: ANDA091166
ndc (product): 71205-581

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 46 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-3989EszopicloneEszopicloneA-S Medication SolutionsANDACurrent
50436-3383EszopicloneEszopicloneUnit Dose ServicesANDACurrent
50436-3384EszopicloneEszopicloneUnit Dose ServicesANDACurrent
53217-150EszopicloneEszopicloneAidarex Pharmaceuticals LLCANDACurrent
60760-526EszopicloneEszopicloneSt Mary's Medical Park PhcyANDACurrent
61919-991ESZOPICLONEESZOPICLONEDirectRXANDACurrent
61919-991ESZOPICLONEESZOPICLONEDirectRXANDACurrent
61919-991ESZOPICLONEESZOPICLONEDirectRXANDACurrent
61919-991ESZOPICLONEESZOPICLONEDirectRXANDACurrent
68071-2403EszopicloneEszopicloneNuCare Pharmaceuticals,Inc.ANDACurrent
68462-382EszopicloneEszopicloneGlenmark Pharmaceuticals Inc. USAANDACurrent
68462-382EszopicloneEszopicloneGlenmark Pharmaceuticals Inc. USAANDACurrent
68462-382EszopicloneEszopicloneGlenmark Pharmaceuticals Inc. USAANDACurrent
68462-382EszopicloneEszopicloneGlenmark Pharmaceuticals Inc. USAANDACurrent
68462-382EszopicloneEszopicloneGlenmark Pharmaceuticals ANDACurrent
68462-382EszopicloneEszopicloneGlenmark Pharmaceuticals Inc. USAANDACurrent
68462-383EszopicloneEszopicloneGlenmark Pharmaceuticals Inc. USAANDACurrent
68462-383EszopicloneEszopicloneGlenmark Pharmaceuticals Inc. USAANDACurrent
68462-383EszopicloneEszopicloneGlenmark Pharmaceuticals Inc. USAANDACurrent
68462-383EszopicloneEszopicloneGlenmark Pharmaceuticals Inc. USAANDACurrent
68462-383EszopicloneEszopicloneGlenmark Pharmaceuticals ANDACurrent
68462-383EszopicloneEszopicloneGlenmark Pharmaceuticals Inc. USAANDACurrent
68462-384EszopicloneEszopicloneGlenmark Pharmaceuticals Inc. USAANDACurrent
68462-384EszopicloneEszopicloneGlenmark Pharmaceuticals Inc. USAANDACurrent
68462-384EszopicloneEszopicloneGlenmark Pharmaceuticals Inc. USAANDACurrent
68462-384EszopicloneEszopicloneGlenmark Pharmaceuticals Inc. USAANDACurrent
68462-384EszopicloneEszopicloneGlenmark Pharmaceuticals ANDACurrent
68462-384EszopicloneEszopicloneGlenmark Pharmaceuticals Inc. USAANDACurrent
68788-8077EszopicloneEszopiclonePreferred Pharmaceuticals Inc. USAANDACurrent
68788-8077EszopicloneEszopiclonePreferred Pharmaceuticals Inc. USAANDACurrent
68788-8923EszopicloneEszopiclonePreferred Pharmaceuticals Inc.ANDACurrent
68788-9318EszopicloneEszopiclonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9318EszopicloneEszopiclonePreferred Pharmaceuticals, Inc.ANDACurrent
70518-0888EszopicloneEszopicloneREMEDYREPACK INC.ANDACurrent
70518-0888EszopicloneEszopicloneREMEDYREPACK INC.ANDACurrent
71205-581EszopicloneEszopicloneProficient Rx LPANDACurrent
71205-581EszopicloneEszopicloneProficient Rx LPANDACurrent
71205-633EszopicloneEszopicloneProficient Rx LPANDACurrent
71205-633EszopicloneEszopicloneProficient Rx LPANDACurrent
71205-633EszopicloneEszopicloneProficient Rx LPANDACurrent
71335-0512EszopicloneEszopicloneBryant Ranch PrepackANDACurrent
71335-0512EszopicloneEszopicloneBryant Ranch PrepackANDACurrent
71335-0512EszopicloneEszopicloneBryant Ranch PrepackANDACurrent
71335-0512EszopicloneEszopicloneBryant Ranch PrepackANDACurrent
71335-0574EszopicloneEszopicloneBryant Ranch PrepackANDACurrent
71335-2002EszopicloneEszopicloneBryant Ranch PrepackANDACurrent