medline

Generic: acetaminophen

Labeler: medline industries, lp
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name medline
Generic Name acetaminophen
Labeler medline industries, lp
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/1

Manufacturer
Medline Industries, LP

Identifiers & Regulatory

Product NDC 53329-197
Product ID 53329-197_1cd8105b-61d9-1400-e063-6394a90a8422
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA211544
Listing Expiration 2026-12-31
Marketing Start 2024-07-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53329197
Hyphenated Format 53329-197

Supplemental Identifiers

RxCUI
1148399
UPC
0197344036281
UNII
362O9ITL9D

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 medline (source: ndc)
Generic Name acetaminophen (source: ndc)
Application Number ANDA211544 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/1
source: ndc
Packaging
  • 50 TABLET, EXTENDED RELEASE in 1 BOTTLE (53329-197-29)
source: ndc

Packages (1)

53329-197-29 50 TABLET, EXTENDED RELEASE in 1 BOTTLE (53329-197-29)

Ingredients (1)

acetaminophen (650 mg/1)

Linked Drug Pages (1)

Medline ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1cd8105b-61d9-1400-e063-6394a90a8422", "openfda": {"upc": ["0197344036281"], "unii": ["362O9ITL9D"], "rxcui": ["1148399"], "spl_set_id": ["fc5fb080-bb9b-3283-e053-6394a90aabfb"], "manufacturer_name": ["Medline Industries, LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 TABLET, EXTENDED RELEASE in 1 BOTTLE (53329-197-29)", "package_ndc": "53329-197-29", "marketing_start_date": "20240701"}], "brand_name": "Medline", "product_id": "53329-197_1cd8105b-61d9-1400-e063-6394a90a8422", "dosage_form": "TABLET, EXTENDED RELEASE", "product_ndc": "53329-197", "generic_name": "acetaminophen", "labeler_name": "Medline Industries, LP", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Medline", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/1"}], "application_number": "ANDA211544", "marketing_category": "ANDA", "marketing_start_date": "20240701", "listing_expiration_date": "20261231"}