ranitidine

Generic: ranitidine

Labeler: pharmaceutical associates, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ranitidine
Generic Name ranitidine
Labeler pharmaceutical associates, inc.
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

ranitidine 15 mg/mL

Manufacturer
Pharmaceutical Associates, Inc.

Identifiers & Regulatory

Product NDC 0121-4727
Product ID 0121-4727_d56a22ea-5dab-e98a-e053-2a95a90a34c4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077405
Listing Expiration 2026-12-31
Marketing Start 2010-11-01

Pharmacologic Class

Established (EPC)
histamine-2 receptor antagonist [epc]
Mechanism of Action
histamine h2 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01214727
Hyphenated Format 0121-4727

Supplemental Identifiers

RxCUI
705610
UNII
884KT10YB7
NUI
N0000000151 N0000175784

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 ranitidine (source: ndc)
Generic Name ranitidine (source: ndc)
Application Number ANDA077405 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/mL
source: ndc
Packaging
  • 4 TRAY in 1 CASE (0121-4727-10) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE
source: ndc

Packages (1)

0121-4727-10 4 TRAY in 1 CASE (0121-4727-10) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE

Ingredients (1)

ranitidine (15 mg/mL)

Linked Drug Pages (1)

Ranitidine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d56a22ea-5dab-e98a-e053-2a95a90a34c4", "openfda": {"nui": ["N0000000151", "N0000175784"], "unii": ["884KT10YB7"], "rxcui": ["705610"], "spl_set_id": ["d0da9dd6-c691-4614-99c7-531b0bf34837"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Pharmaceutical Associates, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 TRAY in 1 CASE (0121-4727-10)  / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE", "package_ndc": "0121-4727-10", "marketing_start_date": "20101101"}], "brand_name": "Ranitidine", "product_id": "0121-4727_d56a22ea-5dab-e98a-e053-2a95a90a34c4", "dosage_form": "SYRUP", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "0121-4727", "generic_name": "RANITIDINE", "labeler_name": "Pharmaceutical Associates, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ranitidine", "active_ingredients": [{"name": "RANITIDINE", "strength": "15 mg/mL"}], "application_number": "ANDA077405", "marketing_category": "ANDA", "marketing_start_date": "20101101", "listing_expiration_date": "20261231"}