sodium bicarbonate

Generic: sodium bicarbonate

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH FINAL Inactive Finished

Drug Facts

Product Profile

Brand Name sodium bicarbonate
Generic Name sodium bicarbonate
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sodium bicarbonate 650 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 43353-162
Product ID 43353-162_36d1abdc-f28b-4c0d-98ea-07718706c695
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH FINAL
Application Number part331
Listing Expiration 2026-12-31
Marketing Start 2015-05-01

Pharmacologic Class

Classes
increased large intestinal motility [pe] inhibition large intestine fluid/electrolyte absorption [pe] osmotic activity [moa] osmotic laxative [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43353162
Hyphenated Format 43353-162

Supplemental Identifiers

RxCUI
198861
UNII
8MDF5V39QO

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 sodium bicarbonate (source: ndc)
Generic Name sodium bicarbonate (source: ndc)
Application Number part331 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE, PLASTIC (43353-162-53)
  • 90 TABLET in 1 BOTTLE, PLASTIC (43353-162-60)
  • 120 TABLET in 1 BOTTLE, PLASTIC (43353-162-70)
  • 180 TABLET in 1 BOTTLE, PLASTIC (43353-162-80)
  • 200 TABLET in 1 BOTTLE, PLASTIC (43353-162-85)
  • 360 TABLET in 1 BOTTLE, PLASTIC (43353-162-94)
source: ndc

Packages (6)

43353-162-53 60 TABLET in 1 BOTTLE, PLASTIC (43353-162-53) 43353-162-60 90 TABLET in 1 BOTTLE, PLASTIC (43353-162-60) 43353-162-70 120 TABLET in 1 BOTTLE, PLASTIC (43353-162-70) 43353-162-80 180 TABLET in 1 BOTTLE, PLASTIC (43353-162-80) 43353-162-85 200 TABLET in 1 BOTTLE, PLASTIC (43353-162-85) 43353-162-94 360 TABLET in 1 BOTTLE, PLASTIC (43353-162-94)

Ingredients (1)

sodium bicarbonate (650 mg/1)

Linked Drug Pages (1)

SODIUM BICARBONATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "36d1abdc-f28b-4c0d-98ea-07718706c695", "openfda": {"unii": ["8MDF5V39QO"], "rxcui": ["198861"], "spl_set_id": ["15605a6d-6c90-47d5-9d1f-f66a3f27d5fc"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (43353-162-53)", "package_ndc": "43353-162-53", "marketing_start_date": "20160330"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (43353-162-60)", "package_ndc": "43353-162-60", "marketing_start_date": "20160222"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE, PLASTIC (43353-162-70)", "package_ndc": "43353-162-70", "marketing_start_date": "20160222"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE, PLASTIC (43353-162-80)", "package_ndc": "43353-162-80", "marketing_start_date": "20160330"}, {"sample": false, "description": "200 TABLET in 1 BOTTLE, PLASTIC (43353-162-85)", "package_ndc": "43353-162-85", "marketing_start_date": "20160302"}, {"sample": false, "description": "360 TABLET in 1 BOTTLE, PLASTIC (43353-162-94)", "package_ndc": "43353-162-94", "marketing_start_date": "20160222"}], "brand_name": "SODIUM BICARBONATE", "product_id": "43353-162_36d1abdc-f28b-4c0d-98ea-07718706c695", "dosage_form": "TABLET", "pharm_class": ["Increased Large Intestinal Motility [PE]", "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]", "Osmotic Activity [MoA]", "Osmotic Laxative [EPC]"], "product_ndc": "43353-162", "generic_name": "SODIUM BICARBONATE", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SODIUM BICARBONATE", "active_ingredients": [{"name": "SODIUM BICARBONATE", "strength": "650 mg/1"}], "application_number": "part331", "marketing_category": "OTC MONOGRAPH FINAL", "marketing_start_date": "20150501", "listing_expiration_date": "20261231"}