Home NDC 0121-1576 Metoclopramide
Product NDC 0121-1576
11-digit product format 001211576
Labeler code 0121
Product ID 0121-1576_9e77216c-c14e-4318-8569-288652321db9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name metoclopramide hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler PAI Holdings, LLC dba PAI Pharma
Application ANDA072744
Marketing category ANDA
Marketing start 1991-06-01
Substance METOCLOPRAMIDE HYDROCHLORIDE
Active strength 5 mg/5mL
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 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA RS 1991-05-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A072744-001 AA
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 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA RS 1991-05-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA RS 1991-05-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA RS 1991-05-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA RS 1991-05-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA RS 1991-05-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA RS 1991-05-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA RS 1991-05-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA RS 1991-05-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA RS 1991-05-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA RS 1991-05-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA RS 1991-05-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA RS 1991-05-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA RS 1991-05-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA RS 1991-05-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA 1991-05-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA 1991-05-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA 1991-05-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA 1991-05-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA 1991-05-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA 1991-05-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA 1991-05-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA 1991-05-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA 1991-05-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA 1991-05-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA 1991-05-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA 1991-05-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA 1991-05-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA RS 1991-05-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA RS 1991-05-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA RS 1991-05-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA RS 1991-05-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA RS 1991-05-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA 1991-05-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA 1991-05-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA 1991-05-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA 1991-05-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA 1991-05-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA 1991-05-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA 1991-05-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA 1991-05-28 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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METOCLOPRAMIDE HYDROCHLORIDE 5 mg/5mL
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 104884 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 0121-1576-10 Metoclopramide 10 in 1 TRAY SOLUTION 10 15 0121-1576-10 Metoclopramide 10 in 1 CASE SOLUTION 10 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Metoclopramide Hydrochloride ACTIVE INGREDIENT W1792A2RVD METOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 9 Metoclopramide ACTIVE MOIETY L4YEB44I46 METOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 9 citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP METOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 9 FD&C Yellow No. 6 INACTIVE INGREDIENT H77VEI93A8 METOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 9 glycerin INACTIVE INGREDIENT PDC6A3C0OX METOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 9 methylparaben INACTIVE INGREDIENT A2I8C7HI9T METOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 9 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH METOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 9 sorbitol INACTIVE INGREDIENT 506T60A25R METOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 9 water INACTIVE INGREDIENT 059QF0KO0R METOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0121-1576 METOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] 15 Current NDC, Legacy NDC, 2 package rows 20241115_3cc8ca5b-8b71-4c77-a181-9ce154597b9a.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 · 3 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 0121-1576-10 00121157610 10 TRAY in 1 CASE (0121-1576-10) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE 10 tray 1991-06-01 0000-00-00 No No Current