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United States · US · US:60846-301_aedc4160-2165-451e-8a3b-26d3bb911242
NIZATIDINE
Orange BookUNIISPLATC A02BA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeA02BA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116084630115480 mL in 1 BOTTLE (60846-301-15)
Annotations
UNII (FDA Substance ID)
P41PML4GHR
NIZATIDINE
RxCUI 42319
Orange Book
A090576
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": "60846-301_aedc4160-2165-451e-8a3b-26d3bb911242",
"productndc": "60846-301",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "090576",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "15MG/ML",
"product_no": "001",
"approval_date": "Nov 18, 2009"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NIZATIDINE",
"proprietary_name": "NIZATIDINE",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA090576",
"marketing_category": "ANDA",
"nonproprietary_name": "NIZATIDINE",
"start_marketing_date": "20160812",
"active_numerator_strength": "15"
}Related drugs
Other records sharing ATC code A02BA04.
- FIAxidWhitehall Laboratories Limited
- CAAXIDPENDOPHARM DIVISION OF PHARMASCIENCE INC
- GBAxid 100mg/4ml solution for infusion ampoulesFlynn Pharma Ltd
- GBAxid 150mg capsulesFlynn Pharma Ltd
- GBAxid 150mg capsulesDowelhurst Ltd
- GBAxid 300mg capsulesFlynn Pharma Ltd
- FINitsatidiini EnnapharmaTeva Pharma B.V.
- FINitsatidiini EnnapharmaTeva Pharma B.V.
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