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United States · US · US:64980-637_b4d3aa30-82b1-45e5-89bb-829c5ccf7ffe
RANITIDINE
Orange BookUNIISPLATC A02BA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeA02BA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11649806370330 TABLET in 1 BOTTLE (64980-637-03)
Annotations
UNII (FDA Substance ID)
BK76465IHM
RANITIDINE HYDROCHLORIDE
RxCUI 203136
Orange Book
A211289
ABAB
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": "64980-637_b4d3aa30-82b1-45e5-89bb-829c5ccf7ffe",
"productndc": "64980-637",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "211289",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 150MG BASE",
"product_no": "001",
"approval_date": "Jan 31, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 300MG BASE",
"product_no": "002",
"approval_date": "Jan 31, 2019"
}
],
"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": "ANDA211289",
"marketing_category": "ANDA",
"nonproprietary_name": "RANITIDINE",
"start_marketing_date": "20251206",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code A02BA02.
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