monobasic sodium phosphate and dibasic sodium phosphate

Generic: monobasic sodium phosphate and dibasic sodium phosphate

Labeler: lupin pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name monobasic sodium phosphate and dibasic sodium phosphate
Generic Name monobasic sodium phosphate and dibasic sodium phosphate
Labeler lupin pharmaceuticals,inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sodium phosphate, dibasic, anhydrous .398 g/1, sodium phosphate, monobasic, monohydrate 1.105 g/1

Manufacturer
Lupin Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 43386-030
Product ID 43386-030_a1083256-d69a-4ff6-be4e-9719451792ef
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079247
Listing Expiration 2026-12-31
Marketing Start 2012-01-20

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 43386030
Hyphenated Format 43386-030

Supplemental Identifiers

UPC
0343386030019
UNII
22ADO53M6F 593YOG76RN

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 monobasic sodium phosphate and dibasic sodium phosphate (source: ndc)
Generic Name monobasic sodium phosphate and dibasic sodium phosphate (source: ndc)
Application Number ANDA079247 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .398 g/1
  • 1.105 g/1
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are white to off-white uncoated tablet, modified oval shaped, biconvex, bisect on one side and plain on the other. Debossed "N" on the left side of the bisect and "03" on the right side of the bisect. Each Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablet contains 1.102 grams of monobasic sodium phosphate, USP and 0.398 grams of dibasic sodium phosphate, USP for a total of 1.5 grams of sodium phosphate per tablet. Inert ingredients include polyethylene glycol 8000, NF; and magnesium stearate, NF. Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets is packaged in a multi-dose, child-resistant bottle containing 100 tablets: NDC 43386-030-01. Each bottle contains two silica desiccant packets, which should not be ingested. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Discard any unused portion.
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL PDP
source: label

Packages (0)

No package records.

Ingredients (2)

sodium phosphate, dibasic, anhydrous (.398 g/1) sodium phosphate, monobasic, monohydrate (1.105 g/1)

Linked Drug Pages (1)

Monobasic Sodium Phosphate and Dibasic Sodium Phosphate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a1083256-d69a-4ff6-be4e-9719451792ef", "openfda": {"upc": ["0343386030019"], "unii": ["22ADO53M6F", "593YOG76RN"], "spl_set_id": ["e2fcc382-6fac-4438-ad02-ebc8528dd59a"], "manufacturer_name": ["Lupin Pharmaceuticals,Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Monobasic Sodium Phosphate and Dibasic Sodium Phosphate", "product_id": "43386-030_a1083256-d69a-4ff6-be4e-9719451792ef", "dosage_form": "TABLET", "pharm_class": ["Increased Large Intestinal Motility [PE]", "Increased Large Intestinal Motility [PE]", "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]", "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]", "Osmotic Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Osmotic Laxative [EPC]"], "product_ndc": "43386-030", "generic_name": "Monobasic Sodium Phosphate and Dibasic Sodium Phosphate", "labeler_name": "Lupin Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Monobasic Sodium Phosphate and Dibasic Sodium Phosphate", "active_ingredients": [{"name": "SODIUM PHOSPHATE, DIBASIC, ANHYDROUS", "strength": ".398 g/1"}, {"name": "SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE", "strength": "1.105 g/1"}], "application_number": "ANDA079247", "marketing_category": "ANDA", "marketing_start_date": "20120120", "listing_expiration_date": "20261231"}