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Pyridostigmine Bromide

Pyridostigmine Bromide Extended-Release Tablets (180 mg) Rx only

Approved
Approval ID

901ade23-0893-7fad-e053-2a95a90a09a8

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 19, 2021

Manufacturers
FDA

NuCare Pharmaceuticals,Inc.

DUNS: 010632300

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

PYRIDOSTIGMINE BROMIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68071-5032
Application NumberANDA203184
Product Classification
M
Marketing Category
C73584
G
Generic Name
PYRIDOSTIGMINE BROMIDE
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 19, 2021
FDA Product Classification

INGREDIENTS (6)

CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PYRIDOSTIGMINE BROMIDEActive
Quantity: 180 mg in 1 1
Code: KVI301NA53
Classification: ACTIB

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Pyridostigmine Bromide - FDA Drug Approval Details