NDC codes

FDA NDC Directory
Product NDC (as listed)46287-020Labeler and product segments. Claims need a package NDC.
Product NDC at billing width46287-0020Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
46287-020-0146287002001473 mL in 1 BOTTLE (46287-020-01)Marketed from Aug 4, 2017
46287-020-0446287002004118 mL in 1 BOTTLE (46287-020-04)Marketed from Aug 4, 2017
46287-020-504628700205010 CUP, UNIT-DOSE in 1 CARTON (46287-020-50) / 5 mL in 1 CUP, UNIT-DOSEMarketed from Jul 15, 2021

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
CaroSpir
Generic name (nonproprietary)
carospir
Active ingredients
Spironolactone — 25 mg/5mL
Dosage form
Suspension
Route
Oral
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 209478
Marketing start
Listing expires
Other FDA classes
Aldosterone Antagonists (Mechanism)
Identifiers
Product ID 46287-020_341fea14-cdc7-4c75-b1ca-706e90dc0128SPL ID 341fea14-cdc7-4c75-b1ca-706e90dc0128SPL set ID c4f70a04-7d89-4b73-8b02-17d43471bf08RxCUI 104232UNII 27O7W4T232UPC 0346287020011, 0346287020042
Pharmacologic class
Aldosterone Antagonist

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.

NDC on a medical claim

N446287002001 followed by a unit qualifier and the quantity

Package 46287-0020-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under NDA 209478

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 209478
ProductStrengthForm · routeLabelerProduct NDC
SpironolactoneSpironolactone 25 mg/5mLSuspensionOralATLANTIC BIOLOGICALS CORP.17856-1133
SpironolactoneSpironolactone 25 mg/5mLSuspensionOralAtlantic Biologicals Corp.17856-1233
SpironolactoneSpironolactone 25 mg/5mLSuspensionOralPadagis US LLC0574-1133

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