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United States · US · US:53746-253_906b462d-e4a3-4f23-8d1b-2605476c40e8
Ranitidine
Orange BookUNIISPLATC A02BA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals of New York LLC
CountryUS (United States)
ATC codeA02BA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc115374625301100 TABLET in 1 BOTTLE (53746-253-01)
- ndc115374625305500 TABLET in 1 BOTTLE (53746-253-05)
- ndc1153746253101000 TABLET in 1 BOTTLE (53746-253-10)
- ndc115374625318180 TABLET in 1 BOTTLE (53746-253-18)
- ndc11537462536060 TABLET in 1 BOTTLE (53746-253-60)
Annotations
UNII (FDA Substance ID)
BK76465IHM
RANITIDINE HYDROCHLORIDE
RxCUI 203136
Orange Book
A077824
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "BK76465IHM",
"rxcui": "203136",
"inchikey": "GGWBHVILAJZWKJ-UHFFFAOYSA-N",
"display_name": "RANITIDINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"b38a3332-5c54-453f-aeb7-070f830955c2": {
"match": "brand_token",
"title": "RANITIDINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]",
"spl_version": "21",
"published_date": "2026-05-04"
}
},
"productid": "53746-253_906b462d-e4a3-4f23-8d1b-2605476c40e8",
"productndc": "53746-253",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "077824",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 150MG BASE",
"product_no": "001",
"approval_date": "Oct 13, 2006"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 300MG BASE",
"product_no": "002",
"approval_date": "Oct 13, 2006"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "RANITIDINE HYDROCHLORIDE",
"proprietary_name": "Ranitidine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA077824",
"marketing_category": "ANDA",
"nonproprietary_name": "Ranitidine",
"start_marketing_date": "20091216",
"active_numerator_strength": "150"
}Related drugs
Other records sharing ATC code A02BA02.
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