pyridostigmine bromide

Generic: pyridostigmine bromide

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name pyridostigmine bromide
Generic Name pyridostigmine bromide
Labeler amneal pharmaceuticals llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

pyridostigmine bromide 105 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 60846-559
Product ID 60846-559_50c63e12-f90c-4343-af31-b69d07ca2259
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA217604
Listing Expiration 2027-12-31
Marketing Start 2024-10-09

Pharmacologic Class

Classes
cholinesterase inhibitor [epc] cholinesterase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60846559
Hyphenated Format 60846-559

Supplemental Identifiers

RxCUI
2695047
UPC
0360846559279 0360846559101
UNII
KVI301NA53

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name pyridostigmine bromide (source: ndc)
Generic Name pyridostigmine bromide (source: ndc)
Application Number NDA217604 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 105 mg/1
source: ndc
Packaging
  • 10 CARTON in 1 BAG (60846-559-10) / 1 BLISTER PACK in 1 CARTON (60846-559-27) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (1)

60846-559-10 10 CARTON in 1 BAG (60846-559-10) / 1 BLISTER PACK in 1 CARTON (60846-559-27) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (1)

pyridostigmine bromide (105 mg/1)

Linked Drug Pages (1)

Pyridostigmine bromide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "50c63e12-f90c-4343-af31-b69d07ca2259", "openfda": {"upc": ["0360846559279", "0360846559101"], "unii": ["KVI301NA53"], "rxcui": ["2695047"], "spl_set_id": ["52d6f195-165a-400b-a13b-489e94bcf0b0"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 CARTON in 1 BAG (60846-559-10)  / 1 BLISTER PACK in 1 CARTON (60846-559-27)  / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "60846-559-10", "marketing_start_date": "20241009"}], "brand_name": "Pyridostigmine bromide", "product_id": "60846-559_50c63e12-f90c-4343-af31-b69d07ca2259", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "60846-559", "generic_name": "Pyridostigmine bromide", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pyridostigmine bromide", "active_ingredients": [{"name": "PYRIDOSTIGMINE BROMIDE", "strength": "105 mg/1"}], "application_number": "NDA217604", "marketing_category": "NDA", "marketing_start_date": "20241009", "listing_expiration_date": "20271231"}