METOCLOPRAMIDE HYDROCHLORIDE

Product NDC
61919-150
Requested package NDC
61919-150-90
11-digit product format
619190150
Labeler code
61919
Product ID
61919-150_9c993997-4847-41af-e053-2995a90ab890
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METOCLOPRAMIDE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA072801
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
METOCLOPRAMIDE HYDROCHLORIDE
Active strength
5 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage61919-15061919-150-90IInactivated 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 · 16 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded 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
A072801-001METOCLOPRAMIDE HYDROCHLORIDEMETOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A072801-001AB

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 UTC2026-02A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-153f01610625f2…
2019-09-15 20:21 UTC2019-09A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A072801-001METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB1993-06-15cb3db0bc1861…

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 UTC2026-02A072801-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072801-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A072801-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072801-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072801-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072801-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072801-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072801-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072801-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072801-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072801-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072801-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072801-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072801-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072801-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072801-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072801-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072801-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072801-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072801-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072801-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A072801-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072801-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072801-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072801-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A072801-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A072801-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072801-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072801-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072801-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072801-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072801-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072801-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072801-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A072801-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A072801-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072801-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072801-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A072801-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A072801-001AB1cb3db0bc1861…

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
61919-150-902023-01-30C16284748780-1f386c649-bedb-0266-e053-dadaa90a7c1aMETOCLOPRAMIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-150-90METOCLOPRAMIDE HYDROCHLORIDE90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-150-90EA - Each61919-150a4a4f1c3-08ec-4060-af4b-6a818c59bf0712015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METOCLOPRAMIDE HYDROCHLORIDEACTIVE INGREDIENTW1792A2RVDMETOCLOPRAMIDE HYDROCHLORIDE TABLET [DIRECT RX]1
METOCLOPRAMIDEACTIVE MOIETYL4YEB44I46METOCLOPRAMIDE HYDROCHLORIDE TABLET [DIRECT RX]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JMETOCLOPRAMIDE HYDROCHLORIDE TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETOCLOPRAMIDE HYDROCHLORIDE TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METOCLOPRAMIDE HYDROCHLORIDE TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METOCLOPRAMIDE HYDROCHLORIDE TABLET [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETOCLOPRAMIDE HYDROCHLORIDE TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-150METOCLOPRAMIDE HYDROCHLORIDE TABLET [DIRECT RX]3Legacy NDC, 1 package rows20200121_1c714687-2ed3-4da0-b6e4-4fbc207d480b.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetoclopramideMETOCLOPRAMIDECardinal Health 107, LLC7eeaa7bc-c94f-47d0-94e5-e35ccadca19e2026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072801
application number: ANDA072801
MetoclopramideMETOCLOPRAMIDECoupler LLC5345a125-0cee-472e-e063-6394a90aeb212026-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072801
application number: ANDA072801
MetoclopramideMETOCLOPRAMIDESafecor Health LLC15d616d7-2f4c-4882-a03c-fcc86c18f5f82026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072801
application number: ANDA072801
MetoclopramideMETOCLOPRAMIDETeva Pharmaceuticals USA, Inc.e15905e0-e0f6-4c8b-ac19-59724d6c4bf02026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072801
application number: ANDA072801
MetoclopramideMETOCLOPRAMIDENuCare Pharmaceuticals, Inc.4524146c-f588-083b-e063-6294a90ac9772025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072801
application number: ANDA072801
MetoclopramideMETOCLOPRAMIDEMylan Institutional Inc.447dbb34-7903-4e6a-be31-48a0b0e0d2f52025-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072801
application number: ANDA072801
MetoclopramideMETOCLOPRAMIDENCS HealthCare of KY, LLC dba Vangard Labs4ab8ddab-8226-4b5a-8774-308ed49d6bc42025-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072801
application number: ANDA072801
MetoclopramideMETOCLOPRAMIDEAmerican Health Packaging998f1782-bbfa-469b-9fe1-c612e8588f702024-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072801
application number: ANDA072801
MetoclopramideMETOCLOPRAMIDENuCare Pharmaceuticals, Inc.46dcafbc-9d50-316a-e054-00144ff88e882024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072801
application number: ANDA072801
MetoclopramideMETOCLOPRAMIDEBryant Ranch Prepack6f0a13cc-9346-4f4a-9a0d-b725045b01aa2024-05-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072801
application number: ANDA072801

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311668metoclopramide HCl 5 MG Oral TabletPSN1c714687-2ed3-4da0-b6e4-4fbc207d480b3
311668metoclopramide 5 MG Oral TabletSCD1c714687-2ed3-4da0-b6e4-4fbc207d480b3
311668metoclopramide 5 MG (as metoclopramide hydrochloride) Oral TabletSY1c714687-2ed3-4da0-b6e4-4fbc207d480b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-150-906191901509090 TABLET in 1 BOTTLE (61919-150-90) 90 tablet2015-01-010000-00-00NoNoCurrent