acarbose

Generic: acarbose

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acarbose
Generic Name acarbose
Labeler chartwell rx, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acarbose 100 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-455
Product ID 62135-455_458bb3c6-f92c-cf49-e063-6294a90a96c2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202271
Listing Expiration 2026-12-31
Marketing Start 2021-04-16

Pharmacologic Class

Established (EPC)
alpha-glucosidase inhibitor [epc]
Mechanism of Action
alpha glucosidase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135455
Hyphenated Format 62135-455

Supplemental Identifiers

RxCUI
199149 199150 200132
UPC
0362135453909 0362135455903 0362135454906
UNII
T58MSI464G
NUI
N0000000166 N0000175559

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 acarbose (source: ndc)
Generic Name acarbose (source: ndc)
Application Number ANDA202271 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (62135-455-90)
source: ndc

Packages (1)

62135-455-90 90 TABLET in 1 BOTTLE (62135-455-90)

Ingredients (1)

acarbose (100 mg/1)

Linked Drug Pages (1)

Acarbose ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "458bb3c6-f92c-cf49-e063-6294a90a96c2", "openfda": {"nui": ["N0000000166", "N0000175559"], "upc": ["0362135453909", "0362135455903", "0362135454906"], "unii": ["T58MSI464G"], "rxcui": ["199149", "199150", "200132"], "spl_set_id": ["d1b627e1-d78d-47dd-93f5-2bf4998466ba"], "pharm_class_epc": ["alpha-Glucosidase Inhibitor [EPC]"], "pharm_class_moa": ["alpha Glucosidase Inhibitors [MoA]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (62135-455-90)", "package_ndc": "62135-455-90", "marketing_start_date": "20230131"}], "brand_name": "Acarbose", "product_id": "62135-455_458bb3c6-f92c-cf49-e063-6294a90a96c2", "dosage_form": "TABLET", "pharm_class": ["alpha Glucosidase Inhibitors [MoA]", "alpha-Glucosidase Inhibitor [EPC]"], "product_ndc": "62135-455", "generic_name": "acarbose", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acarbose", "active_ingredients": [{"name": "ACARBOSE", "strength": "100 mg/1"}], "application_number": "ANDA202271", "marketing_category": "ANDA", "marketing_start_date": "20210416", "listing_expiration_date": "20261231"}