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United States · US · US:68382-659_5439e6be-2d67-4bbd-b72f-3364cb62f907
pyridostigmine bromide
Orange BookUNIISPLATC N07AA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals (USA) Inc.
CountryUS (United States)
ATC codeN07AA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc116838265901100 TABLET in 1 BOTTLE (68382-659-01)
- ndc116838265905500 TABLET in 1 BOTTLE (68382-659-05)
- ndc11683826590630 TABLET in 1 BOTTLE (68382-659-06)
- ndc11683826591690 TABLET in 1 BOTTLE (68382-659-16)
Annotations
UNII (FDA Substance ID)
KVI301NA53
PYRIDOSTIGMINE BROMIDE
RxCUI 9001
Orange Book
A205650
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": "68382-659_5439e6be-2d67-4bbd-b72f-3364cb62f907",
"productndc": "68382-659",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "205650",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "60MG",
"product_no": "001",
"approval_date": "Jun 22, 2015"
}
],
"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": "ANDA205650",
"marketing_category": "ANDA",
"nonproprietary_name": "pyridostigmine bromide",
"start_marketing_date": "20150807",
"active_numerator_strength": "60"
}Related drugs
Other records sharing ATC code N07AA02.
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