Home NDC 83980-011 Metoclopramide
Product NDC 83980-011
11-digit product format 839800011
Labeler code 83980
Product ID 83980-011_045886c5-5926-4d9e-a13c-8b0efc188862
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metoclopramide
Dosage form TABLET
Route ORAL
Labeler Ipca Laboratories Limited
Application ANDA078807
Marketing category ANDA
Marketing start 2025-01-09
Substance METOCLOPRAMIDE HYDROCHLORIDE
Active strength 10 mg/1
Pharmacologic classes Dopamine D2 Antagonists [MoA], Dopamine-2 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078807-001 METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2008-06-12 A078807-002 METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2008-06-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A078807-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2008-06-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078807-002 METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2008-06-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078807-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2008-06-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078807-002 METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2008-06-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078807-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2008-06-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078807-002 METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2008-06-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078807-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2008-06-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078807-002 METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2008-06-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078807-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2008-06-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078807-002 METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2008-06-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078807-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2008-06-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078807-002 METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2008-06-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078807-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2008-06-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078807-002 METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2008-06-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078807-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2008-06-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078807-002 METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2008-06-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078807-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2008-06-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078807-002 METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2008-06-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078807-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2008-06-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078807-002 METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2008-06-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078807-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2008-06-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078807-002 METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2008-06-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078807-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2008-06-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078807-002 METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2008-06-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078807-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2008-06-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078807-002 METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2008-06-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078807-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2008-06-12 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078807-002 METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2008-06-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078807-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2008-06-12 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078807-002 METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2008-06-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078807-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2008-06-12 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078807-002 METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2008-06-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078807-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2008-06-12 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078807-002 METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2008-06-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078807-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2008-06-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078807-002 METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2008-06-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078807-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2008-06-12 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A078807-002 METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2008-06-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078807-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2008-06-12 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A078807-002 METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2008-06-12 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Metoclopramide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination W1792A2RVD Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311666 Internal RxNorm lookup 311668 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83980-011-01 Metoclopramide 100 in 1 BOTTLE TABLET 100 2 83980-011-05 Metoclopramide 500 in 1 BOTTLE TABLET 500 2 83980-011-10 Metoclopramide 1000 in 1 BOTTLE TABLET 1000 2 83980-011-13 Metoclopramide 30 in 1 BOTTLE TABLET 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83980-011 METOCLOPRAMIDE TABLET [IPCA LABORATORIES LIMITED] 1 Current NDC, 4 package rows 20250110_c143e210-4ce7-44e5-b1e2-bf0e6bfde485.zip
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83980-011-01 83980001101 100 TABLET in 1 BOTTLE (83980-011-01) 100 tablet 2025-01-09 No No Current 83980-011-05 83980001105 500 TABLET in 1 BOTTLE (83980-011-05) 500 tablet 2025-01-09 No No Current 83980-011-10 83980001110 1000 TABLET in 1 BOTTLE (83980-011-10) 1000 tablet 2025-01-09 No No Current 83980-011-13 83980001113 30 TABLET in 1 BOTTLE (83980-011-13) 30 tablet 2025-01-09 No No Current