Application 077214

Type
ANDA
Sponsor
ACME LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZOLPIDEM TARTRATEZOLPIDEM TARTRATETABLET;ORAL5MGNoNo
002ZOLPIDEM TARTRATEZOLPIDEM TARTRATETABLET;ORAL10MGNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077214-001ZOLPIDEM TARTRATEZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-23
A077214-002ZOLPIDEM TARTRATEZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077214-001AB
A077214-002AB

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077214-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077214-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077214-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077214-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A077214-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077214-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077214-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077214-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077214-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077214-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077214-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077214-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077214-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077214-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077214-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077214-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077214-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077214-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077214-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A077214-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077214-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077214-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077214-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077214-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077214-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077214-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077214-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-238072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077214-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077214-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077214-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077214-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077214-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077214-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-234b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077214-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077214-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-2374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077214-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077214-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-23bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077214-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077214-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-23782e0a99824c…
2021-12-28 21:50 UTC2021-12A077214-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-23782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077214-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077214-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077214-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077214-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077214-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077214-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077214-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077214-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077214-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077214-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077214-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077214-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077214-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077214-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077214-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077214-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077214-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077214-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077214-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077214-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077214-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077214-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077214-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077214-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077214-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077214-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077214-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077214-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077214-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077214-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077214-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077214-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077214-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077214-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077214-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077214-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077214-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077214-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077214-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A077214-002AB1782e0a99824c…

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 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEGolden State Medical Supply, Inc.2b5cf535-ccdc-ecd7-e063-6394a90a726e2026-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077214
application number: ANDA077214
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEThe ACME Laboratories Ltd.5679ed64-8424-4e63-a3c9-91d80fff2ca62026-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077214
application number: ANDA077214
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEAphena Pharma Solutions - Tennessee, LLC3882d72d-686b-406b-e063-6294a90a0b892025-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077214
application number: ANDA077214
ZOLPIDEM TARTRATEZOLPIDEM TARTRATEAphena Pharma Solutions - Tennessee, LLC349053e4-9885-ec0b-e063-6294a90ad79a2025-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077214
application number: ANDA077214
ZolpidemZOLPIDEM TARTRATEAphena Pharma Solutions - Tennessee, LLC1e15d6e3-8d06-0936-e063-6394a90ab8db2025-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077214
application number: ANDA077214
ZolpidemZOLPIDEM TARTRATEAphena Pharma Solutions - Tennessee, LLC1e13ad50-f846-813a-e063-6294a90a58782024-09-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077214
application number: ANDA077214
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepack8cef5718-c562-43c3-8abe-a2fc5235ad2a2024-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077214
application number: ANDA077214
ndc (product): 63629-8998
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepackfff2e7fc-2f7e-43c9-bfb3-d929ecc9eb722024-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077214
application number: ANDA077214
ndc (product): 63629-1170
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepack74c4e793-3444-4d3d-8211-26374349ab1e2024-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077214
application number: ANDA077214
ZolpidemZOLPIDEM TARTRATEAdvanced Rx of Tennessee, LLC1fa86b79-8809-35f4-e063-6394a90a43772024-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077214
application number: ANDA077214
ZolpidemZOLPIDEM TARTRATEGolden State Medical Supply, Inc.1a8f7696-0d02-dd1f-e063-6394a90a58662024-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077214
application number: ANDA077214
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepack70d7cfc3-7e54-4cd8-8911-7cf115d5c8202024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077214
application number: ANDA077214
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepack23bce69d-7918-42c2-8020-e22f292ff31f2024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077214
application number: ANDA077214
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepack3aa7e88b-7929-45ac-9e81-03f4abf28e942024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077214
application number: ANDA077214
ndc (product): 63629-8999
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepack1e5b61b6-a5bd-4f09-9d34-905ce32f18992024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077214
application number: ANDA077214
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepackc6824c69-76bc-4ca0-a6b1-5cddc2c42fc92024-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077214
application number: ANDA077214
ndc (product): 63629-1171
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepackdf130798-1458-455b-a4e1-c33c4ecee43b2023-12-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077214
application number: ANDA077214
ZolpidemZOLPIDEM TARTRATEBryant Ranch Prepack33094305-4bbd-4b52-9079-8853d5f836822023-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077214
application number: ANDA077214
ZolpidemZOLPIDEM TARTRATEACI Healthcare USA, Inc021153ce-fe27-4ed1-8d88-b4157b0ed7342023-11-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077214
application number: ANDA077214
ndc (product): 71093-156
ndc (product): 71093-155
ZolpidemZOLPIDEM TARTRATEAphena Pharma Solutions - Tennessee, LLC8581cfad-525b-4b16-b116-a5138d9fda522022-10-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077214
application number: ANDA077214
ndc (product): 71610-670

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0086Zolpidem Tartratezolpidem tartrateRoxane Laboratories, IncANDACurrent
0054-0087Zolpidem Tartratezolpidem tartrateRoxane Laboratories, IncANDACurrent
50436-0009ZolpidemZolpidem TartrateUnit Dose ServicesANDACurrent
63629-1170ZolpidemZolpidem TartrateBryant Ranch PrepackANDACurrent
63629-1170ZolpidemZolpidem TartrateBryant Ranch PrepackANDACurrent
63629-1171ZolpidemZolpidem TartrateBryant Ranch PrepackANDACurrent
63629-1171ZolpidemZolpidem TartrateBryant Ranch PrepackANDACurrent
63629-1171ZolpidemZolpidem TartrateBryant Ranch PrepackANDACurrent
63629-8998ZolpidemZolpidem TartrateBryant Ranch PrepackANDACurrent
63629-8998ZolpidemZolpidem TartrateBryant Ranch PrepackANDACurrent
63629-8999ZolpidemZolpidem TartrateBryant Ranch PrepackANDACurrent
63629-8999ZolpidemZolpidem TartrateBryant Ranch PrepackANDACurrent
68071-2642ZolpidemZolpidem TartrateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2774ZolpidemZolpidem TartrateNuCare Pharmaceuticals,Inc.ANDACurrent
70934-917ZolpidemZolpidem TartrateDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71093-155ZolpidemZolpidem TartrateACI Healthcare USA, IncANDACurrent
71093-155ZolpidemZolpidem TartrateACI Healthcare USA, IncANDACurrent
71093-155ZolpidemZolpidem TartrateACI Healthcare USA, IncANDACurrent
71093-155ZolpidemZolpidem TartrateACI Healthcare USA, IncANDACurrent
71093-156ZolpidemZolpidem TartrateACI Healthcare USA, IncANDACurrent
71093-156ZolpidemZolpidem TartrateACI Healthcare USA, IncANDACurrent
71093-156ZolpidemZolpidem TartrateACI Healthcare USA, IncANDACurrent
71093-156ZolpidemZolpidem TartrateACI Healthcare USA, IncANDACurrent
71205-691ZolpidemZolpidem TartrateProficient Rx LPANDACurrent
71610-670ZolpidemZolpidem TartrateAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9018ORIG2007-05-01