Application 071250

Type
ANDA
Sponsor
IMPAX LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METOCLOPRAMIDE HYDROCHLORIDEMETOCLOPRAMIDE HYDROCHLORIDETABLET;ORALEQ 10MG BASENoNo
002METOCLOPRAMIDE HYDROCHLORIDEMETOCLOPRAMIDE HYDROCHLORIDETABLET;ORALEQ 5MG BASENoNo

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
A071250-001METOCLOPRAMIDE HYDROCHLORIDEMETOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL1988-02-03
A071250-002METOCLOPRAMIDE HYDROCHLORIDEMETOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORAL1995-12-28

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 UTC2026-02A071250-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL1988-02-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071250-002METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORAL1995-12-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071250-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL1988-02-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071250-002METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORAL1995-12-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A071250-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL1988-02-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071250-002METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORAL1995-12-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071250-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1988-02-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071250-002METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1995-12-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071250-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1988-02-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071250-002METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1995-12-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071250-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1988-02-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071250-002METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1995-12-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071250-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1988-02-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071250-002METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1995-12-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071250-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1988-02-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071250-002METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1995-12-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071250-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1988-02-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071250-002METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1995-12-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071250-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1988-02-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A071250-002METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1995-12-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071250-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1988-02-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071250-002METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1995-12-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071250-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1988-02-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071250-002METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1995-12-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071250-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1988-02-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071250-002METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1995-12-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071250-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1988-02-038072bd15b7f6…
2024-05-31 18:47 UTC2024-05A071250-002METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1995-12-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071250-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1988-02-035c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071250-002METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1995-12-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071250-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1988-02-035d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A071250-002METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1995-12-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071250-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1988-02-034b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A071250-002METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1995-12-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071250-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1988-02-0374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A071250-002METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1995-12-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071250-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1988-02-03bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A071250-002METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1995-12-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071250-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1988-02-03782e0a99824c…
2021-12-28 21:50 UTC2021-12A071250-002METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1995-12-28782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071250-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071250-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071250-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071250-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071250-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071250-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071250-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071250-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071250-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071250-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071250-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071250-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071250-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A071250-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071250-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071250-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071250-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071250-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071250-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071250-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071250-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A071250-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071250-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071250-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071250-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A071250-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071250-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A071250-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071250-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A071250-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071250-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A071250-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071250-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A071250-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071250-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071250-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A071250-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A071250-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071250-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A071250-002AB18869cabd3fbd…

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetoclopramideMETOCLOPRAMIDE HYDROCHLORIDEATLANTIC BIOLOGICALS CORP.3cd4b274-6176-4e5b-9765-4f50763bd58f2026-07-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METOCLOPRAMIDE HYDROCHLORIDE
MetoclopramideMETOCLOPRAMIDE HYDROCHLORIDEAvenacy, LLCdc4a13f8-1e9b-4c75-82c0-bcd11f0a9a662026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METOCLOPRAMIDE HYDROCHLORIDE
METOCLOPRAMIDEMETOCLOPRAMIDE HYDROCHLORIDEHenry Schein, Inc.f50c8fb4-23c4-4762-95bb-e4ca7b289a4d2026-04-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METOCLOPRAMIDE HYDROCHLORIDE
MetoclopramideMETOCLOPRAMIDE HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.50a3cf38-66dc-4fa5-8a45-adf959c987ab2026-04-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METOCLOPRAMIDE HYDROCHLORIDE
GIMOTIMETOCLOPRAMIDE HYDROCHLORIDEEvoke Pharma, Inc.95269b1f-779c-4ca0-9f86-e74e677f99002026-02-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METOCLOPRAMIDE HYDROCHLORIDE
ReglanMETOCLOPRAMIDE HYDROCHLORIDEANI Pharmaceuticals, Inc.de55c133-eb08-4a35-91a2-5dc0930273972026-02-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METOCLOPRAMIDE HYDROCHLORIDE
metoclopramide hydrochlorideMETOCLOPRAMIDE HYDROCHLORIDEChartwell RX, LLCdc364325-dd39-4259-a348-3760eccdca4b2026-02-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: metoclopramide hydrochloride
generic name: METOCLOPRAMIDE HYDROCHLORIDE
metoclopramide hydrochlorideMETOCLOPRAMIDE HYDROCHLORIDEChartwell Governmental & Specialty RX, LLC.c4ab34f2-25e6-47bd-9dde-1f4baf469f0d2025-11-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: metoclopramide hydrochloride
generic name: METOCLOPRAMIDE HYDROCHLORIDE
MetoclopramideMETOCLOPRAMIDE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma3cc8ca5b-8b71-4c77-a181-9ce154597b9a2024-11-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METOCLOPRAMIDE HYDROCHLORIDE
MetoclopramideMETOCLOPRAMIDE HYDROCHLORIDEGenus Lifesciences Inc.74358569-7a24-4a59-a7fc-500d2341d6cb2024-05-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METOCLOPRAMIDE HYDROCHLORIDE
MetoclopramideMETOCLOPRAMIDE HYDROCHLORIDEFresenius Kabi USA, LLCcc739885-e10e-4bcb-a781-c726c518f3d12023-06-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METOCLOPRAMIDE HYDROCHLORIDE
MetoclopramideMETOCLOPRAMIDE HYDROCHLORIDEMedical Purchasing Solutions, LLCd163182b-582d-df59-e053-2995a90a300b2023-05-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METOCLOPRAMIDE HYDROCHLORIDE
METOCLOPRAMIDE hydrochlorideMETOCLOPRAMIDE HYDROCHLORIDELupin Pharmaceuticals,Inc.7cd1dc35-2fb2-4f1d-8769-24c3c3aa34fa2020-12-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METOCLOPRAMIDE hydrochloride
generic name: METOCLOPRAMIDE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-1651Metoclopramide HydrochlorideMetoclopramide HydrochlorideImpax GenericsANDACurrent
0115-1651Metoclopramide HydrochlorideMetoclopramide HydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1651Metoclopramide HydrochlorideMetoclopramide HydrochlorideImpax GenericsANDACurrent
0615-8038Metoclopramide HydrochlorideMetoclopramide HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8071Metoclopramide HydrochlorideMetoclopramide HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
21695-346MetoclopramideMetoclopramideRebel Distributors Corp.ANDACurrent
42254-266Metoclopramide HydrochlorideMetoclopramide HydrochlorideRebel Distributors CorpANDACurrent
43353-808Metoclopramide HydrochlorideMetoclopramide HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
53808-0623Metoclopramide HydrochlorideMetoclopramide HydrochlorideState of Florida DOH Central PharmacyANDACurrent
53808-0722MetoclopramideMetoclopramideState of Florida DOH Central PharmacyANDACurrent
55154-6848Metoclopramide HydrochlorideMetoclopramide HydrochlorideCardinal HealthANDACurrent
63739-293Metoclopramide HydrochlorideMetoclopramide HydrochlorideMcKesson Corporation dba SKY PackagingANDACurrent
63739-293Metoclopramide HydrochlorideMetoclopramide HydrochlorideMcKesson CorporationANDACurrent
67296-0880Metoclopramide HydrochlorideMetoclopramide HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-0880Metoclopramide HydrochlorideMetoclopramide HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-0883Metoclopramide HydrochlorideMetoclopramide HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-0883Metoclopramide HydrochlorideMetoclopramide HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1810Metoclopramide HydrochlorideMetoclopramide HydrochlorideRedPharm Drug, Inc.ANDACurrent
68071-3031Metoclopramide HydrochlorideMetoclopramide HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3262Metoclopramide HydrochlorideMetoclopramide HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3262Metoclopramide HydrochlorideMetoclopramide HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68788-6791Metoclopramide HydrochlorideMetoclopramide HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-6791Metoclopramide HydrochlorideMetoclopramide HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-6791Metoclopramide HydrochlorideMetoclopramide HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-6791Metoclopramide HydrochlorideMetoclopramide HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9706Metoclopramide HydrochlorideMetoclopramide HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
71335-0522Metoclopramide HydrochlorideMetoclopramide HydrochlorideBryant Ranch PrepackANDACurrent
71335-0522Metoclopramide HydrochlorideMetoclopramide HydrochlorideBryant Ranch PrepackANDACurrent