acetaminophen

Generic: acetaminophen tablet extended release

Labeler: time cap laboratories, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen
Generic Name acetaminophen tablet extended release
Labeler time cap laboratories, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/1

Manufacturer
TIME CAP LABORATORIES, INC.

Identifiers & Regulatory

Product NDC 49483-699
Product ID 49483-699_02a5f067-4b67-ecc7-e063-6294a90a92c3
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA215486
Listing Expiration 2026-12-31
Marketing Start 2021-10-04

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49483699
Hyphenated Format 49483-699

Supplemental Identifiers

RxCUI
1148399
UPC
0349483699401 0349483699265 0349483704051 0349483699425 0349483699012
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 acetaminophen (source: ndc)
Generic Name acetaminophen tablet extended release (source: ndc)
Application Number ANDA215486 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (49483-699-01)
  • 50 BOTTLE in 1 CARTON (49483-699-05) / 1 TABLET, EXTENDED RELEASE in 1 BOTTLE
  • 225 TABLET, EXTENDED RELEASE in 1 BOTTLE (49483-699-26)
  • 400 TABLET, EXTENDED RELEASE in 1 BOTTLE (49483-699-40)
  • 1 BOTTLE in 1 CARTON (49483-699-42) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE
source: ndc

Packages (5)

49483-699-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (49483-699-01) 49483-699-05 50 BOTTLE in 1 CARTON (49483-699-05) / 1 TABLET, EXTENDED RELEASE in 1 BOTTLE 49483-699-26 225 TABLET, EXTENDED RELEASE in 1 BOTTLE (49483-699-26) 49483-699-40 400 TABLET, EXTENDED RELEASE in 1 BOTTLE (49483-699-40) 49483-699-42 1 BOTTLE in 1 CARTON (49483-699-42) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE

Ingredients (1)

acetaminophen (650 mg/1)

Linked Drug Pages (1)

Acetaminophen, Muscle Aches and Pains Acetaminophen extended release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "02a5f067-4b67-ecc7-e063-6294a90a92c3", "openfda": {"upc": ["0349483699401", "0349483699265", "0349483704051", "0349483699425", "0349483699012"], "unii": ["362O9ITL9D"], "rxcui": ["1148399"], "spl_set_id": ["cd4d0ad4-7206-94c8-e053-2a95a90aaa14"], "manufacturer_name": ["TIME CAP LABORATORIES, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (49483-699-01)", "package_ndc": "49483-699-01", "marketing_start_date": "20211004"}, {"sample": false, "description": "50 BOTTLE in 1 CARTON (49483-699-05)  / 1 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "49483-699-05", "marketing_start_date": "20211004"}, {"sample": false, "description": "225 TABLET, EXTENDED RELEASE in 1 BOTTLE (49483-699-26)", "package_ndc": "49483-699-26", "marketing_start_date": "20221107"}, {"sample": false, "description": "400 TABLET, EXTENDED RELEASE in 1 BOTTLE (49483-699-40)", "package_ndc": "49483-699-40", "marketing_start_date": "20211004"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (49483-699-42)  / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "49483-699-42", "marketing_start_date": "20221107"}], "brand_name": "Acetaminophen", "product_id": "49483-699_02a5f067-4b67-ecc7-e063-6294a90a92c3", "dosage_form": "TABLET, EXTENDED RELEASE", "product_ndc": "49483-699", "generic_name": "Acetaminophen tablet extended release", "labeler_name": "TIME CAP LABORATORIES, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acetaminophen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/1"}], "application_number": "ANDA215486", "marketing_category": "ANDA", "marketing_start_date": "20211004", "listing_expiration_date": "20261231"}