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United States · US · US:55111-310_254e5866-1ba8-8d97-bc03-19916119ff87
Nizatidine
Orange BookUNIISPLATC A02BA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr Reddy's Laboratories Limited
CountryUS (United States)
ATC codeA02BA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc115511131001100 CAPSULE in 1 BOTTLE (55111-310-01)
- ndc115511131005500 CAPSULE in 1 BOTTLE (55111-310-05)
- ndc11551113103030 CAPSULE in 1 BOTTLE (55111-310-30)
- ndc11551113106060 CAPSULE in 1 BOTTLE (55111-310-60)
- ndc11551113107810 BLISTER PACK in 1 CARTON (55111-310-78) / 10 CAPSULE in 1 BLISTER PACK (55111-310-79)
Annotations
UNII (FDA Substance ID)
P41PML4GHR
NIZATIDINE
RxCUI 42319
Orange Book
A077314
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "P41PML4GHR",
"rxcui": "42319",
"inchikey": "SGXXNSQHWDMGGP-UHFFFAOYSA-N",
"display_name": "NIZATIDINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"e9957997-8b85-48a0-9bb3-b878cb223236": {
"match": "brand_token",
"title": "NIZATIDINE CAPSULE [EPIC PHARMA, LLC]",
"spl_version": "1",
"published_date": "2025-01-06"
}
},
"productid": "55111-310_254e5866-1ba8-8d97-bc03-19916119ff87",
"productndc": "55111-310",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "077314",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "150MG",
"product_no": "001",
"approval_date": "Sep 15, 2005"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "002",
"approval_date": "Sep 15, 2005"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NIZATIDINE",
"proprietary_name": "Nizatidine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA077314",
"marketing_category": "ANDA",
"nonproprietary_name": "Nizatidine",
"start_marketing_date": "20050915",
"active_numerator_strength": "150"
}Related drugs
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- FINitsatidiini EnnapharmaTeva Pharma B.V.
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