Metoclopramide

Product NDC
55154-4378
11-digit product format
551544378
Labeler code
55154
Product ID
55154-4378_7fa8ee95-9241-44d4-95c1-6be52c8c1c82
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoclopramide
Dosage form
TABLET
Route
ORAL
Labeler
Cardinal Health
Application
ANDA070184
Marketing category
ANDA
Marketing start
2014-01-02
Marketing end
2021-06-30
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
0000-00-00
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 productproduct55154-4378DDiscontinued by firm2026-08-11
excluded packagepackage55154-437855154-4378-0DDiscontinued 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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55154-4378-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55154-4378-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55154-4378-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55154-4378-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55154-4378-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55154-4378-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55154-4378-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55154-4378-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55154-4378-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55154-4378-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55154-4378-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55154-4378-0557ba5c1ecfa…9c80585c8c6e…

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
A070184-001METOCLOPRAMIDE HYDROCHLORIDEMETOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A070184-001AB

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 UTC2026-02A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-293f01610625f2…
2019-09-15 20:21 UTC2019-09A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A070184-001METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB1985-07-29cb3db0bc1861…

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 UTC2026-02A070184-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070184-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A070184-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070184-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070184-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070184-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070184-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070184-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070184-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070184-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070184-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070184-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070184-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070184-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070184-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070184-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070184-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070184-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070184-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070184-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070184-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A070184-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070184-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070184-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070184-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A070184-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A070184-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070184-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070184-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070184-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070184-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070184-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070184-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070184-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A070184-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A070184-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070184-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070184-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070184-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A070184-001AB1cb3db0bc1861…

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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetoclopramideMETOCLOPRAMIDEREMEDYREPACK INC.5d31d815-50fa-4e78-8ebd-affc2514ce782026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070184
application number: ANDA070184
MetoclopramideMETOCLOPRAMIDEPreferred Pharmaceuticals Inc.697ec7b1-945a-4a31-b585-f051dc2461652026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070184
application number: ANDA070184
MetoclopramideMETOCLOPRAMIDECoupler LLC5345905d-18b0-1e42-e063-6394a90af7452026-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070184
application number: ANDA070184
MetoclopramideMETOCLOPRAMIDESafecor Health LLC15d616d7-2f4c-4882-a03c-fcc86c18f5f82026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070184
application number: ANDA070184
MetoclopramideMETOCLOPRAMIDEREMEDYREPACK INC.6637cb78-d50a-4dbf-8fb7-b1b5102c5c5f2026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070184
application number: ANDA070184
MetoclopramideMETOCLOPRAMIDETeva Pharmaceuticals USA, Inc.e15905e0-e0f6-4c8b-ac19-59724d6c4bf02026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070184
application number: ANDA070184
MetoclopramideMETOCLOPRAMIDEAvKAREff067ac5-6efc-3e86-e6d5-590b2779491c2026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070184
application number: ANDA070184
MetoclopramideMETOCLOPRAMIDENorthwind Health Company, LLCf2b732ab-b859-7252-e053-2995a90af0d82026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070184
application number: ANDA070184
MetoclopramideMETOCLOPRAMIDEMylan Institutional Inc.447dbb34-7903-4e6a-be31-48a0b0e0d2f52025-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070184
application number: ANDA070184
MetoclopramideMETOCLOPRAMIDENCS HealthCare of KY, LLC dba Vangard Labs4ab8ddab-8226-4b5a-8774-308ed49d6bc42025-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070184
application number: ANDA070184
MetoclopramideMETOCLOPRAMIDEAmerican Health Packaging998f1782-bbfa-469b-9fe1-c612e8588f702024-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070184
application number: ANDA070184
MetoclopramideMETOCLOPRAMIDENuCare Pharmaceuticals, Inc.40cf021d-5f2a-055c-e054-00144ff88e882024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070184
application number: ANDA070184
MetoclopramideMETOCLOPRAMIDENuCare Pharmaceuticals,Inc.5d7cd5a0-4a84-4084-e053-2a91aa0a686f2024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070184
application number: ANDA070184
MetoclopramideMETOCLOPRAMIDEBryant Ranch Prepack23f11d3c-1529-4bb6-a61e-e4bab1a3e98e2024-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070184
application number: ANDA070184
MetoclopramideMETOCLOPRAMIDEBryant Ranch Prepack31da0c8b-8171-4bd2-9832-12ba85e36b372024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070184
application number: ANDA070184
MetoclopramideMETOCLOPRAMIDEA-S Medication Solutions264c4f48-51f4-458f-9e61-1adafdf604fc2023-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070184
application number: ANDA070184
MetoclopramideMETOCLOPRAMIDEProficient Rx LPce367a41-89d3-45c2-aac2-36fce43062d02023-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070184
application number: ANDA070184

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-4378-05515443780010 BLISTER PACK in 1 BAG (55154-4378-0) > 1 TABLET in 1 BLISTER PACK10 blister pack2014-01-022021-06-30NoNoCurrent