Home NDC 83634-779 Metoclopramide
Product NDC 83634-779
11-digit product format 836340779
Labeler code 83634
Product ID 83634-779_d6819f4b-aff3-476c-9cb3-b20bd518dd99
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name metoclopramide hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Avenacy Inc.
Application ANDA204756
Marketing category ANDA
Marketing start 2024-06-30
Substance METOCLOPRAMIDE HYDROCHLORIDE
Active strength 5 mg/mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204756-001 METOCLOPRAMIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-12-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204756-001 AP
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 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 A204756-001 METOCLOPRAMIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-12-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204756-001 METOCLOPRAMIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-12-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204756-001 METOCLOPRAMIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-12-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204756-001 METOCLOPRAMIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-12-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204756-001 METOCLOPRAMIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-12-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204756-001 METOCLOPRAMIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-12-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204756-001 METOCLOPRAMIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-12-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204756-001 METOCLOPRAMIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-12-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204756-001 METOCLOPRAMIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-12-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204756-001 METOCLOPRAMIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-12-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204756-001 METOCLOPRAMIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-12-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204756-001 METOCLOPRAMIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-12-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204756-001 METOCLOPRAMIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-12-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204756-001 METOCLOPRAMIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-12-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204756-001 METOCLOPRAMIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-12-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204756-001 METOCLOPRAMIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-12-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204756-001 METOCLOPRAMIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-12-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204756-001 METOCLOPRAMIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-12-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204756-001 METOCLOPRAMIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-12-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204756-001 METOCLOPRAMIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-12-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204756-001 METOCLOPRAMIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-12-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204756-001 METOCLOPRAMIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-12-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204756-001 METOCLOPRAMIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-12-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204756-001 METOCLOPRAMIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-12-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204756-001 METOCLOPRAMIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-12-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204756-001 METOCLOPRAMIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-12-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204756-001 METOCLOPRAMIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-12-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204756-001 METOCLOPRAMIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-12-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204756-001 METOCLOPRAMIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-12-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204756-001 METOCLOPRAMIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-12-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204756-001 METOCLOPRAMIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-12-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204756-001 METOCLOPRAMIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-12-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204756-001 METOCLOPRAMIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-12-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204756-001 METOCLOPRAMIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-12-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204756-001 METOCLOPRAMIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-12-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204756-001 METOCLOPRAMIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-12-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204756-001 METOCLOPRAMIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-12-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204756-001 METOCLOPRAMIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-12-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204756-001 METOCLOPRAMIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-12-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204756-001 METOCLOPRAMIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-12-20 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 5 mg/mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311670 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 83634-779-02 Metoclopramide 25 in 1 CARTON INJECTION, SOLUTION 25 1 83634-779-41 Metoclopramide 2 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 2 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83634-779 METOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) INJECTION, SOLUTION [AVENACY INC.] 1 Current NDC, 2 package rows 20240630_dc4a13f8-1e9b-4c75-82c0-bcd11f0a9a66.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Metoclopramide METOCLOPRAMIDE HYDROCHLORIDE Avenacy, LLC dc4a13f8-1e9b-4c75-82c0-bcd11f0a9a66 2026-06-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204756 application number: ANDA204756 ndc (product): 83634-779 METOCLOPRAMIDE METOCLOPRAMIDE HYDROCHLORIDE Henry Schein, Inc. f50c8fb4-23c4-4762-95bb-e4ca7b289a4d 2026-04-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204756 application number: ANDA204756 Metoclopramide METOCLOPRAMIDE HYDROCHLORIDE Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 50a3cf38-66dc-4fa5-8a45-adf959c987ab 2026-04-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204756 application number: ANDA204756 Metoclopramide METOCLOPRAMIDE HYDROCHLORIDE Medical Purchasing Solutions, LLC d163182b-582d-df59-e053-2995a90a300b 2023-05-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204756 application number: ANDA204756
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83634-779-02 83634077902 25 VIAL, SINGLE-DOSE in 1 CARTON (83634-779-02) / 2 mL in 1 VIAL, SINGLE-DOSE (83634-779-41) 2024-06-30 No No Current 83634-779-41 83634077941 2 mL in 1 VIAL, SINGLE-DOSE 2 ml Historical