Metoclopramide Hydrochloride

Product NDC
67296-0883
11-digit product format
672960883
Labeler code
67296
Product ID
67296-0883_9c9afbc3-be5b-1991-e053-2995a90a17ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoclopramide Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA071250
Marketing category
ANDA
Marketing start
2011-08-22
Marketing end
0000-00-00
Substance
METOCLOPRAMIDE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
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 productproduct67296-0883IInactivated by FDA2026-08-11
excluded packagepackage67296-088367296-0883-1IInactivated by FDA2026-08-11

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 · 38 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 productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67296-0883-1IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67296-0883-1IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67296-0883-1IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67296-0883-1IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67296-0883-1IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67296-0883-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67296-0883-1IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67296-0883-1IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67296-0883-1IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67296-0883-1IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67296-0883-1IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67296-0883-1IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-0883-1IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-0883-1IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-0883-1IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage67296-0883-1IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage67296-0883-1IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage67296-0883-1IInactivated by FDAbd6a592717d7…303034d00443…
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 packagepackage67296-0883-1EExcluded 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A071250-001METOCLOPRAMIDE HYDROCHLORIDEMETOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL1988-02-03
A071250-002METOCLOPRAMIDE HYDROCHLORIDEMETOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORAL1995-12-28

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A071250-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL1988-02-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071250-002METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORAL1995-12-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071250-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL1988-02-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071250-002METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORAL1995-12-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A071250-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORAL1988-02-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071250-002METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORAL1995-12-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071250-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1988-02-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071250-002METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1995-12-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071250-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1988-02-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071250-002METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1995-12-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071250-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1988-02-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071250-002METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1995-12-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071250-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1988-02-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071250-002METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1995-12-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071250-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1988-02-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071250-002METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1995-12-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071250-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1988-02-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071250-002METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1995-12-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071250-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1988-02-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A071250-002METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1995-12-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071250-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1988-02-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071250-002METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1995-12-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071250-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1988-02-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071250-002METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1995-12-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071250-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1988-02-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071250-002METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1995-12-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071250-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1988-02-038072bd15b7f6…
2024-05-31 18:47 UTC2024-05A071250-002METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1995-12-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071250-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1988-02-035c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071250-002METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1995-12-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071250-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1988-02-035d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A071250-002METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1995-12-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071250-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1988-02-034b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A071250-002METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1995-12-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071250-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1988-02-0374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A071250-002METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1995-12-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071250-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1988-02-03bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A071250-002METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1995-12-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071250-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1988-02-03782e0a99824c…
2021-12-28 21:50 UTC2021-12A071250-002METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1995-12-28782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071250-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071250-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071250-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071250-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071250-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071250-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071250-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071250-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071250-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071250-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071250-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071250-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071250-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A071250-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071250-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071250-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071250-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071250-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071250-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071250-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071250-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A071250-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071250-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071250-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071250-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A071250-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071250-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A071250-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071250-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A071250-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071250-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A071250-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071250-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A071250-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071250-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071250-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A071250-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A071250-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071250-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A071250-002AB18869cabd3fbd…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
86441fd8-22b8-41db-bb26-c70dffc3923bProduct name120210111
340a6817-217a-4b71-9e83-8e2e60c4b0c5Product name120150319
1f2c49ec-0a44-8021-ecde-b27ece080b13Product name120140508
46471181-3fa6-5fcd-1d9f-1bb9d2b06171Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-0883-12022-01-28C16284748780-1d6a99b39-ed96-a426-e053-dadaa90af4c243048cc4-fc68-114a-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0883-1Metoclopramide Hydrochloride15 in 1 BOTTLETABLET153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0883METOCLOPRAMIDE HYDROCHLORIDE TABLET [REDPHARM DRUG, INC.]3Legacy NDC, 1 package rows20200123_43048cc4-fc68-114a-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311666metoclopramide HCl 10 MG Oral TabletPSN43048cc4-fc68-114a-e054-00144ff8d46c3
311666metoclopramide 10 MG Oral TabletSCD43048cc4-fc68-114a-e054-00144ff8d46c3
311666metoclopramide (as metoclopramide HCl) 10 MG Oral TabletSY43048cc4-fc68-114a-e054-00144ff8d46c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-0883-16729608830115 TABLET in 1 BOTTLE (67296-0883-1) 15 tablet2011-08-220000-00-00NoNoCurrent