What is NDC 46287-020?

46287-020 is the product NDC for CaroSpir, Spironolactone 25 mg/5mL suspension, listed with the FDA by CMP Pharma, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

CMP Pharma, Inc., NDC labeler code 46287. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for CaroSpir?

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.

CaroSpir NDC 46287-020 | National Drug Code

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 NDC	11-digit (billing)	Package
46287-020-01	4628700200146287002001	473 mL in 1 BOTTLE (46287-020-01)Marketed from Aug 4, 2017
46287-020-04	4628700200446287002004	118 mL in 1 BOTTLE (46287-020-04)Marketed from Aug 4, 2017
46287-020-50	4628700205046287002050	10 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
Labeler: CMP Pharma, Inc.NDC labeler code 46287
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 209478
Marketing start: Aug 4, 2017
Listing expires: Dec 31, 2026
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

Current FDA label (SPL), effective Sep 15, 2023.

Indications (excerpt from the label)

CAROSPIR is an antagonist of aldosterone indicated for: the treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure ( 1.1 ) use as an add-on therapy for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.2 ) the management of edema in adult cirrhotic patients when edema is not responsive to fluid and sodium restrictions ( 1.3 ) 1.1 Heart Failure CAROSPIR is indicated for treatment of NYHA Class III-IV heart failure and reduced ejection frac…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 46287-020

What is NDC 46287-020?: 46287-020 is the product NDC for CaroSpir, Spironolactone 25 mg/5mL suspension, listed with the FDA by CMP Pharma, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: CaroSpir.
What is the active ingredient?: Spironolactone.
Who is the labeler?: CMP Pharma, Inc., NDC labeler code 46287. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for CaroSpir?: 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.

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
Product	Strength	Form · route	Labeler	Product NDC
Spironolactone	Spironolactone 25 mg/5mL	SuspensionOral	Padagis US LLC	0574-1133
Spironolactone	Spironolactone 25 mg/5mL	SuspensionOral	ATLANTIC BIOLOGICALS CORP.	17856-1133
Spironolactone	Spironolactone 25 mg/5mL	SuspensionOral	Atlantic Biologicals Corp.	17856-1233