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United States · US · US:0115-3511_3d2e45fb-a83b-4e76-b1cd-9caf2b00a804
Pyridostigmine Bromide
Orange BookUNIISPLATC N07AA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals of New York LLC
CountryUS (United States)
ATC codeN07AA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc110115351101100 TABLET in 1 BOTTLE (0115-3511-01)
- ndc110115351102500 TABLET in 1 BOTTLE (0115-3511-02)
Annotations
UNII (FDA Substance ID)
KVI301NA53
PYRIDOSTIGMINE BROMIDE
RxCUI 9001
Orange Book
A040502
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "KVI301NA53",
"rxcui": "9001",
"inchikey": "VNYBTNPBYXSMOO-UHFFFAOYSA-M",
"display_name": "PYRIDOSTIGMINE BROMIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"52d6f195-165a-400b-a13b-489e94bcf0b0": {
"match": "brand_token",
"title": "PYRIDOSTIGMINE BROMIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC]",
"spl_version": "8",
"published_date": "2026-05-15"
}
},
"productid": "0115-3511_3d2e45fb-a83b-4e76-b1cd-9caf2b00a804",
"productndc": "0115-3511",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "040502",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "60MG",
"product_no": "001",
"approval_date": "Apr 24, 2003"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "30MG",
"product_no": "002",
"approval_date": "Jun 28, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PYRIDOSTIGMINE BROMIDE",
"proprietary_name": "Pyridostigmine Bromide",
"active_ingred_unit": "mg/1",
"application_number": "ANDA040502",
"marketing_category": "ANDA",
"nonproprietary_name": "PYRIDOSTIGMINE BROMIDE",
"start_marketing_date": "20030424",
"active_numerator_strength": "60"
}Related drugs
Other records sharing ATC code N07AA02.
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