Home NDC 17856-0576-3 Metoclopramide
Product NDC 17856-0576
Requested package NDC 17856-0576-3
11-digit product format 178560576
Labeler code 17856
Product ID 17856-0576_3b3f252b-3f29-3484-e063-6394a90a1568
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name metoclopramide hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler ATLANTIC BIOLOGICALS CORP.
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 7 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2024-05-28 21:12 UTC · source 2024-05-28 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2020-12-18 03:04 UTC · source 2020-12-17 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 · 42 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 2026-08-18 06:07:40 2026-07 A072744-001 METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION / ORAL AA RS 1991-05-28 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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/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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 17856-0576-3 Metoclopramide 1 mL in 1 SYRINGE SOLUTION 1 8 17856-0576-4 Metoclopramide 1 mL in 1 SYRINGE SOLUTION 1 8 17856-0576-5 Metoclopramide 5 mL in 1 CUP SOLUTION 5 8 17856-0576-6 Metoclopramide 60 in 1 BOX SOLUTION 60 8 17856-0576-6 Metoclopramide 0.5 mL in 1 SYRINGE SOLUTION 0.5 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17856-0576 METOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) SOLUTION [ATLANTIC BIOLOGICALS CORP.] 7 Current NDC, Legacy NDC, 5 package rows 20240606_3cd4b274-6176-4e5b-9765-4f50763bd58f.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 17856-0576-3 17856057603 1 mL in 1 SYRINGE (17856-0576-3) 1 ml 2021-01-28 0000-00-00 No No Current