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United States · US · US:69238-1731_c11900df-97bb-47f5-8a29-05fe1586d556
Pyridostigmine Bromide
Orange BookUNIISPLATC N07AA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals NY LLC
CountryUS (United States)
ATC codeN07AA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116923817312473 mL in 1 BOTTLE (69238-1731-2)
Annotations
UNII (FDA Substance ID)
KVI301NA53
PYRIDOSTIGMINE BROMIDE
RxCUI 9001
Orange Book
A212702
AA
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": "69238-1731_c11900df-97bb-47f5-8a29-05fe1586d556",
"productndc": "69238-1731",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "212702",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "60MG/5ML",
"product_no": "001",
"approval_date": "Jan 10, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PYRIDOSTIGMINE BROMIDE",
"proprietary_name": "Pyridostigmine Bromide",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA212702",
"marketing_category": "ANDA",
"nonproprietary_name": "Pyridostigmine Bromide",
"start_marketing_date": "20200117",
"active_numerator_strength": "60"
}Related drugs
Other records sharing ATC code N07AA02.
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