FDA.reportPublic FDA data

Application 077878

Type
ANDA
Sponsor
VINTAGE PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METOCLOPRAMIDE HYDROCHLORIDEMETOCLOPRAMIDE HYDROCHLORIDETABLET;ORALEQ 5MG BASENoNo
002METOCLOPRAMIDE 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077878-001METOCLOPRAMIDE HYDROCHLORIDEMETOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2006-08-28
A077878-002METOCLOPRAMIDE HYDROCHLORIDEMETOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2006-08-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077878-001AB
A077878-002AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A077878-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2006-08-28a50c72e98297…
2026-08-01 22:54:322026-06A077878-002METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2006-08-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A077878-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A077878-002AB1a50c72e98297…

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 · 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