Home NDC 76045-101 Metoclopramide
Product NDC 76045-101
11-digit product format 760450101
Labeler code 76045
Product ID 76045-101_4a411ded-d608-41d3-bb26-67d5d5d3c9b5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metoclopramide Hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA091392
Marketing category ANDA
Marketing start 2013-05-03
Substance METOCLOPRAMIDE HYDROCHLORIDE
Active strength 10 mg/2mL
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 A091392-001 METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-04-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091392-001 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 A091392-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION 2013-04-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091392-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION 2013-04-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091392-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION 2013-04-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091392-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-04-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091392-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-04-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091392-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-04-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091392-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-04-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091392-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-04-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091392-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-04-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091392-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-04-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091392-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-04-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091392-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-04-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091392-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-04-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091392-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-04-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091392-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-04-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091392-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-04-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091392-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-04-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091392-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-04-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091392-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-04-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091392-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-04-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091392-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-04-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091392-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-04-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091392-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-04-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091392-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-04-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091392-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-04-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091392-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-04-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091392-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-04-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091392-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-04-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091392-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-04-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091392-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-04-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091392-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-04-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091392-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-04-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091392-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-04-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091392-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-04-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091392-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-04-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091392-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-04-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091392-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-04-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091392-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-04-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091392-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-04-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091392-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2013-04-19 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Metoclopramide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METOCLOPRAMIDE HYDROCHLORIDE 10 mg/2mL
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 727619 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 76045-101-00 Metoclopramide 2 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 2 12 76045-101-00 Metoclopramide 1 in 1 BLISTER PACK INJECTION, SOLUTION 1 12 76045-101-20 Metoclopramide 24 in 1 CARTON INJECTION, SOLUTION 24 12
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76045-101 METOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 12 Current NDC, Legacy NDC, 3 package rows 20230613_cc739885-e10e-4bcb-a781-c726c518f3d1.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 Marketing end Sample Exclude flag Status 76045-101-00 76045010100 2 mL in 1 SYRINGE, GLASS 2 ml Historical 76045-101-20 76045010120 24 BLISTER PACK in 1 CARTON (76045-101-20) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-101-00) / 2 mL in 1 SYRINGE, GLASS 24 blister pack 2013-05-03 0000-00-00 No No Current