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United States · US · US:55111-311_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
- ndc115511131101100 CAPSULE in 1 BOTTLE (55111-311-01)
- ndc115511131105500 CAPSULE in 1 BOTTLE (55111-311-05)
- ndc11551113113030 CAPSULE in 1 BOTTLE (55111-311-30)
- ndc11551113116060 CAPSULE in 1 BOTTLE (55111-311-60)
- ndc11551113117810 BLISTER PACK in 1 CARTON (55111-311-78) / 10 CAPSULE in 1 BLISTER PACK (55111-311-79)
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": "55111-311_254e5866-1ba8-8d97-bc03-19916119ff87",
"productndc": "55111-311",
"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": "300"
}Related drugs
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- GBAxid 150mg capsulesFlynn Pharma Ltd
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- GBAxid 300mg capsulesFlynn Pharma Ltd
- FINitsatidiini EnnapharmaTeva Pharma B.V.
- FINitsatidiini EnnapharmaTeva Pharma B.V.
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