anti-diarrheal

Generic: loperamide hydrochloride

Labeler: imo-gen labs llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name anti-diarrheal
Generic Name loperamide hydrochloride
Labeler imo-gen labs llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

loperamide hydrochloride 2 mg/1

Manufacturer
IMO-GEN LABS LLC

Identifiers & Regulatory

Product NDC 84441-711
Product ID 84441-711_4a027cb4-e23f-282b-e063-6294a90a64c1
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076497
Listing Expiration 2027-12-31
Marketing Start 2024-01-01

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 84441711
Hyphenated Format 84441-711

Supplemental Identifiers

RxCUI
978010
UPC
0860010278116
UNII
77TI35393C

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 anti-diarrheal (source: ndc)
Generic Name loperamide hydrochloride (source: ndc)
Application Number ANDA076497 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 200 TABLET in 1 BOTTLE (84441-711-02)
  • 250 TABLET in 1 BOTTLE (84441-711-25)
  • 96 TABLET in 1 BOTTLE (84441-711-96)
source: ndc

Packages (3)

84441-711-02 200 TABLET in 1 BOTTLE (84441-711-02) 84441-711-25 250 TABLET in 1 BOTTLE (84441-711-25) 84441-711-96 96 TABLET in 1 BOTTLE (84441-711-96)

Ingredients (1)

loperamide hydrochloride (2 mg/1)

Linked Drug Pages (1)

Anti-Diarrheal ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4a027cb4-e23f-282b-e063-6294a90a64c1", "openfda": {"upc": ["0860010278116"], "unii": ["77TI35393C"], "rxcui": ["978010"], "spl_set_id": ["1b5f2c7c-baf0-b213-e063-6394a90a25df"], "manufacturer_name": ["IMO-GEN LABS LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "200 TABLET in 1 BOTTLE (84441-711-02)", "package_ndc": "84441-711-02", "marketing_start_date": "20240101"}, {"sample": false, "description": "250 TABLET in 1 BOTTLE (84441-711-25)", "package_ndc": "84441-711-25", "marketing_start_date": "20260204"}, {"sample": false, "description": "96 TABLET in 1 BOTTLE (84441-711-96)", "package_ndc": "84441-711-96", "marketing_start_date": "20240101"}], "brand_name": "Anti-Diarrheal", "product_id": "84441-711_4a027cb4-e23f-282b-e063-6294a90a64c1", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "84441-711", "generic_name": "Loperamide Hydrochloride", "labeler_name": "IMO-GEN LABS LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Anti-Diarrheal", "active_ingredients": [{"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA076497", "marketing_category": "ANDA", "marketing_start_date": "20240101", "listing_expiration_date": "20271231"}