Metoclopramide

Product NDC
70934-384
Requested package NDC
70934-384-06
11-digit product format
709340384
Labeler code
70934
Product ID
70934-384_b7af7491-fdc1-e6c8-e053-2995a90a96c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoclopramide
Dosage form
TABLET
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA070184
Marketing category
ANDA
Marketing start
2019-06-03
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70934-38470934-384-06IInactivated 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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

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…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-384-06Metoclopramide6 in 1 BOTTLE, PLASTICTABLET62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-384METOCLOPRAMIDE TABLET [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]2Legacy NDC, 1 package rows20201231_95aceb69-720a-60fb-e053-2a95a90a8d4b.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 · 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311666metoclopramide HCl 10 MG Oral TabletPSN95aceb69-720a-60fb-e053-2a95a90a8d4b2
311666metoclopramide 10 MG Oral TabletSCD95aceb69-720a-60fb-e053-2a95a90a8d4b2
311666metoclopramide (as metoclopramide HCl) 10 MG Oral TabletSY95aceb69-720a-60fb-e053-2a95a90a8d4b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-384-06709340384066 TABLET in 1 BOTTLE, PLASTIC (70934-384-06) 6 tablet2019-06-030000-00-00NoNoCurrent