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United States · US · US:62559-165_a7ad286f-c235-42bb-bc51-3f33a17e8dfe
Reglan
Orange BookUNIISPLATC A03FA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA03FA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116255916501100 TABLET in 1 BOTTLE, PLASTIC (62559-165-01)
Annotations
UNII (FDA Substance ID)
W1792A2RVD
METOCLOPRAMIDE HYDROCHLORIDE
RxCUI 267036
Orange Book
N017854
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "W1792A2RVD",
"rxcui": "267036",
"inchikey": "KJBLQGHJOCAOJP-UHFFFAOYSA-N",
"display_name": "METOCLOPRAMIDE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"de55c133-eb08-4a35-91a2-5dc093027397": {
"match": "brand_token",
"title": "REGLAN (METOCLOPRAMIDE HYDROCHLORIDE) TABLET [ANI PHARMACEUTICALS, INC.]",
"spl_version": "8",
"published_date": "2026-02-16"
}
},
"productid": "62559-165_a7ad286f-c235-42bb-bc51-3f33a17e8dfe",
"productndc": "62559-165",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "017854",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 5MG BASE",
"product_no": "002",
"approval_date": "May 5, 1987"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "METOCLOPRAMIDE HYDROCHLORIDE",
"proprietary_name": "Reglan",
"active_ingred_unit": "mg/1",
"application_number": "NDA017854",
"marketing_category": "NDA",
"nonproprietary_name": "Metoclopramide Hydrochloride",
"start_marketing_date": "20110705",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code A03FA01.
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