Application 070581

Type
ANDA
Sponsor
PAR PHARM INC

Application Products#

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

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

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
A070581-001METOCLOPRAMIDE HYDROCHLORIDEMETOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL1985-10-17

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A070581-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL1985-10-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070581-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-10-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A070581-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-10-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070581-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-10-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070581-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-10-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070581-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-10-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070581-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-10-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070581-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-10-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070581-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-10-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070581-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-10-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070581-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-10-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070581-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-10-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070581-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-10-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070581-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-10-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070581-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-10-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070581-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-10-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070581-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-10-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070581-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-10-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070581-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-10-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070581-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-10-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070581-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-10-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A070581-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-10-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070581-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-10-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070581-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-10-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070581-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-10-173f01610625f2…
2019-09-15 20:21 UTC2019-09A070581-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-10-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A070581-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-10-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070581-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-10-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070581-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-10-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070581-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-10-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070581-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-10-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070581-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-10-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070581-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-10-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070581-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-10-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A070581-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-10-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A070581-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-10-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070581-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-10-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070581-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-10-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070581-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-10-17e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A070581-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-10-17cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070581-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A070581-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070581-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070581-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070581-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070581-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070581-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070581-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070581-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070581-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070581-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070581-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070581-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070581-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070581-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070581-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070581-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070581-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070581-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070581-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A070581-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070581-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070581-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070581-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A070581-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A070581-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070581-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070581-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070581-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070581-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070581-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070581-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070581-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A070581-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A070581-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070581-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070581-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070581-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A070581-001AB1cb3db0bc1861…

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 · 39 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-2536MetoclopramideMetoclopramideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7752MetoclopramideMetoclopramideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7932MetoclopramideMetoclopramideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
49884-689MetoclopramideMetoclopramidePar Pharmaceutical, Inc.ANDACurrent
49884-689MetoclopramideMetoclopramidePar Pharmaceutical, Inc.ANDACurrent
49884-689MetoclopramideMetoclopramidePar Pharmaceutical, Inc.ANDACurrent
50090-2221MetoclopramideMetoclopramideA-S Medication SolutionsANDACurrent
50090-2221MetoclopramideMetoclopramideA-S Medication SolutionsANDACurrent
50090-2221MetoclopramideMetoclopramideA-S Medication SolutionsANDACurrent
55154-5976Metoclopramide hydrochlorideMetoclopramide hydrochlorideCardinal HealthANDACurrent
55154-8196MetoclopramideMetoclopramideCardinal Health 107, LLCANDACurrent
55154-8196MetoclopramideMetoclopramideCardinal HealthANDACurrent
55154-8196MetoclopramideMetoclopramideCardinal HealthANDACurrent
63629-7967MetoclopramideMetoclopramideBryant Ranch PrepackANDACurrent
63629-7967MetoclopramideMetoclopramideBryant Ranch PrepackANDACurrent
67296-1738MetoclopramideMetoclopramideRedPharm Drug, Inc.ANDACurrent
67296-1738MetoclopramideMetoclopramideRedPharm Drug, Inc.ANDACurrent
68071-4326MetoclopramideMetoclopramideNuCare Pharmaceuticals,InANDACurrent
68071-4326MetoclopramideMetoclopramideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4326MetoclopramideMetoclopramideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4326MetoclopramideMetoclopramideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4569MetoclopramideMetoclopramideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4569MetoclopramideMetoclopramideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4569MetoclopramideMetoclopramideNuCare Pharmaceuticals,Inc.ANDACurrent
68084-676MetoclopramideMetoclopramideAmerican Health PackagingANDACurrent
68084-676MetoclopramideMetoclopramideAmerican Health PackagingANDACurrent
68084-676MetoclopramideMetoclopramideAmerican Health PackagingANDACurrent
68084-676MetoclopramideMetoclopramideAmerican Health PackagingANDACurrent
68084-676MetoclopramideMetoclopramideAmerican Health PackagingANDACurrent
68788-7226MetoclopramideMetoclopramidePreferred Pharmaceuticals Inc.ANDACurrent
68788-7226MetoclopramideMetoclopramidePreferred Pharmaceuticals Inc.ANDACurrent
68788-7226MetoclopramideMetoclopramidePreferred Pharmaceuticals Inc.ANDACurrent
68788-7226MetoclopramideMetoclopramidePreferred Pharmaceuticals Inc.ANDACurrent
68788-7226MetoclopramideMetoclopramidePreferred Pharmaceuticals Inc.ANDACurrent
70518-0617MetoclopramideMetoclopramideREMEDYREPACK INC.ANDACurrent
70518-0617MetoclopramideMetoclopramideREMEDYREPACK INC.ANDACurrent
71335-0790MetoclopramideMetoclopramideBryant Ranch PrepackANDACurrent
71335-0790MetoclopramideMetoclopramideBryant Ranch PrepackANDACurrent
71335-0790MetoclopramideMetoclopramideBryant Ranch PrepackANDACurrent