Metoclopramide

Product NDC
17856-3727
11-digit product format
178563727
Labeler code
17856
Product ID
17856-3727_46e61d3f-323b-49e3-9c28-a5ddace56457
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metoclopramide hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Atlantic Biologicals Corps
Application
ANDA072744
Marketing category
ANDA
Marketing start
1991-06-01
Marketing end
0000-00-00
Substance
METOCLOPRAMIDE HYDROCHLORIDE
Active strength
5 mg/5mL
Pharmacologic classes
Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct17856-3727DDiscontinued by firm2026-08-11
excluded packagepackage17856-372717856-3727-5DDiscontinued by firm2026-08-11

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 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage17856-3727-5DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17856-3727-5DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage17856-3727-5DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage17856-3727-5DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage17856-3727-5DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage17856-3727-5DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage17856-3727-5DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage17856-3727-5DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage17856-3727-5DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage17856-3727-5DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage17856-3727-5DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage17856-3727-5DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage17856-3727-5IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage17856-3727-5IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage17856-3727-5EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A072744-001METOCLOPRAMIDE HYDROCHLORIDEMETOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLSOLUTION / ORALAARS1991-05-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A072744-001AA

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A072744-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLSOLUTION / ORALAARS1991-05-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072744-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLSOLUTION / ORALAARS1991-05-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A072744-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLSOLUTION / ORALAARS1991-05-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072744-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLSOLUTION / ORALAARS1991-05-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072744-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLSOLUTION / ORALAARS1991-05-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072744-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLSOLUTION / ORALAARS1991-05-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072744-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLSOLUTION / ORALAARS1991-05-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072744-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLSOLUTION / ORALAARS1991-05-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072744-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLSOLUTION / ORALAARS1991-05-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072744-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLSOLUTION / ORALAARS1991-05-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072744-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLSOLUTION / ORALAARS1991-05-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072744-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLSOLUTION / ORALAARS1991-05-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072744-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLSOLUTION / ORALAARS1991-05-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072744-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLSOLUTION / ORALAARS1991-05-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072744-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLSOLUTION / ORALAA1991-05-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072744-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLSOLUTION / ORALAA1991-05-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072744-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLSOLUTION / ORALAA1991-05-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072744-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLSOLUTION / ORALAA1991-05-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072744-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLSOLUTION / ORALAA1991-05-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072744-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLSOLUTION / ORALAA1991-05-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072744-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLSOLUTION / ORALAA1991-05-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A072744-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLSOLUTION / ORALAA1991-05-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072744-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLSOLUTION / ORALAA1991-05-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072744-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLSOLUTION / ORALAA1991-05-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072744-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLSOLUTION / ORALAA1991-05-283f01610625f2…
2019-09-15 20:21 UTC2019-09A072744-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLSOLUTION / ORALAA1991-05-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A072744-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLSOLUTION / ORALAA1991-05-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072744-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLSOLUTION / ORALAARS1991-05-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072744-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLSOLUTION / ORALAARS1991-05-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072744-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLSOLUTION / ORALAARS1991-05-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072744-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLSOLUTION / ORALAARS1991-05-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072744-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLSOLUTION / ORALAARS1991-05-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072744-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLSOLUTION / ORALAA1991-05-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072744-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLSOLUTION / ORALAA1991-05-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A072744-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLSOLUTION / ORALAA1991-05-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A072744-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLSOLUTION / ORALAA1991-05-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072744-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLSOLUTION / ORALAA1991-05-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072744-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLSOLUTION / ORALAA1991-05-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A072744-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLSOLUTION / ORALAA1991-05-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A072744-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLSOLUTION / ORALAA1991-05-28cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A072744-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072744-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A072744-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072744-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072744-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072744-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072744-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072744-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072744-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072744-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072744-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072744-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072744-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072744-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072744-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072744-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072744-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072744-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072744-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072744-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072744-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A072744-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072744-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072744-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072744-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A072744-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A072744-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072744-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072744-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072744-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072744-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072744-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072744-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072744-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A072744-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A072744-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072744-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072744-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A072744-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A072744-001AA1cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-3727-52021-04-29C16284748780-19d75b9d0-4bf4-f424-e053-dadaa90a57ceMETOCLOPRAMIDE ORAL SOLUTION USP
17856-3727-52020-01-31C16284748780-19d75b9d0-4bf4-f424-e053-dadaa90a57ceMETOCLOPRAMIDE ORAL SOLUTION USP

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetoclopramideMETOCLOPRAMIDE HYDROCHLORIDEATLANTIC BIOLOGICALS CORP.3cd4b274-6176-4e5b-9765-4f50763bd58f2026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072744
application number: ANDA072744
MetoclopramideMETOCLOPRAMIDE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma3cc8ca5b-8b71-4c77-a181-9ce154597b9a2024-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072744
application number: ANDA072744
MetoclopramideMETOCLOPRAMIDE HYDROCHLORIDEGenus Lifesciences Inc.74358569-7a24-4a59-a7fc-500d2341d6cb2024-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072744
application number: ANDA072744