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United States · US · US:62559-470_138c3e38-dc2d-46be-8ee6-bef9221a971c
Pyridostigmine Bromide
Orange BookUNIISPLATC N07AA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN07AA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116255947001100 TABLET in 1 BOTTLE (62559-470-01)
Annotations
UNII (FDA Substance ID)
KVI301NA53
PYRIDOSTIGMINE BROMIDE
RxCUI 9001
Orange Book
A040512
AB
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": "62559-470_138c3e38-dc2d-46be-8ee6-bef9221a971c",
"productndc": "62559-470",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "040512",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "60MG",
"product_no": "001",
"approval_date": "Oct 8, 2003"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "30MG",
"product_no": "002",
"approval_date": "Jul 20, 2005"
}
],
"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": "ANDA040512",
"marketing_category": "ANDA",
"nonproprietary_name": "Pyridostigmine Bromide",
"start_marketing_date": "20240116",
"active_numerator_strength": "60"
}Related drugs
Other records sharing ATC code N07AA02.
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