Prescription drug · ANDA
Monobasic Sodium Phosphate and Dibasic Sodium Phosphate NDC 43386-030
Sodium phosphate, Monobasic, Monohydrate 1.105 g/1; Sodium phosphate, Dibasic, Anhydrous .398 g/1 · Tablet · Oral · Lupin Pharmaceuticals,Inc.
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Monobasic Sodium Phosphate and Dibasic Sodium Phosphate
- Generic name (nonproprietary)
- monobasic sodium phosphate and dibasic sodium phosphate
- Active ingredients
- Sodium phosphate, Monobasic, Monohydrate — 1.105 g/1Sodium phosphate, Dibasic, Anhydrous — .398 g/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals,Inc.NDC labeler code 43386
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079247
- Marketing start
- Listing expires
- Other FDA classes
- Increased Large Intestinal Motility (Physiologic effect)Increased Large Intestinal Motility (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Osmotic Activity (Mechanism)Osmotic Activity (Mechanism)
- Identifiers
- Product ID 43386-030_a1083256-d69a-4ff6-be4e-9719451792efSPL ID a1083256-d69a-4ff6-be4e-9719451792efSPL set ID e2fcc382-6fac-4438-ad02-ebc8528dd59aUNII 593YOG76RN, 22ADO53M6FUPC 0343386030019
- Pharmacologic class
- Osmotic Laxative
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are indicated for cleansing of the colon as a preparation for colonoscopy in adults. Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults.
Excerpt only. Read the full label for complete information.
About NDC 43386-030
- What is NDC 43386-030?
- 43386-030 is the product NDC for Monobasic Sodium Phosphate and Dibasic Sodium Phosphate, Sodium phosphate, Monobasic, Monohydrate 1.105 g/1; Sodium phosphate, Dibasic, Anhydrous .398 g/1 tablet, listed with the FDA by Lupin Pharmaceuticals,Inc..
- What drug is associated with this NDC?
- Monobasic Sodium Phosphate and Dibasic Sodium Phosphate.
- What is the active ingredient?
- Sodium phosphate, Monobasic, Monohydrate, Sodium phosphate, Dibasic, Anhydrous.
- Who is the labeler?
- Lupin Pharmaceuticals,Inc., NDC labeler code 43386. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Monobasic Sodium Phosphate and Dibasic Sodium Phosphate?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.