Prescription drug · ANDA

Carvedilol NDC 63187-447

Carvedilol 12.5 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP

NDC codes

FDA NDC Directory
Product NDC (as listed)63187-447Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0447Add 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
63187-447-306318704473030 TABLET, FILM COATED in 1 BOTTLE (63187-447-30)Marketed from Dec 1, 2018
63187-447-606318704476060 TABLET, FILM COATED in 1 BOTTLE (63187-447-60)Marketed from Dec 1, 2018
63187-447-906318704479090 TABLET, FILM COATED in 1 BOTTLE (63187-447-90)Marketed from Dec 1, 2018

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)
Carvedilol
Generic name (nonproprietary)
carvedilol
Active ingredients
Carvedilol — 12.5 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Proficient Rx LPNDC labeler code 63187
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078332
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha-Antagonists (Mechanism)Adrenergic beta1-Antagonists (Mechanism)Adrenergic beta2-Antagonists (Mechanism)
Identifiers
Product ID 63187-447_c48346c2-771d-4929-800c-1066f2def5ddSPL ID c48346c2-771d-4929-800c-1066f2def5ddSPL set ID cd7e7c34-6958-47be-a1c1-f1ed948e2687RxCUI 200032, 200033UNII 0K47UL67F2UPC 0363187447304, 0363187409906
Pharmacologic class
alpha-Adrenergic Blocker; beta-Adrenergic Blocker

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

N463187044730 followed by a unit qualifier and the quantity

Package 63187-0447-30. 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 .

Indications (excerpt from the label)

Carvedilol is an alpha/beta-adrenergic blocking agent indicated for the treatment of: • Left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2) • Hypertension (1.3) 1.2 Left Ventricular Dysfunction Following Myocardial Infarction Carvedilol tablets, USP are indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of ≤40% (with or without symptomatic heart failure) [see Clinical Studies (14.2) ] . 1.3 Hypertension Carvedilol tablets, USP are indicated for the management of essential hypertension [see Clinical Studies (14.3 , 14.4…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63187-447

What is NDC 63187-447?
63187-447 is the product NDC for Carvedilol, Carvedilol 12.5 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Carvedilol.
What is the active ingredient?
Carvedilol.
Who is the labeler?
Proficient Rx LP, NDC labeler code 63187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Carvedilol?
167 other product NDCs are listed under this name. See all Carvedilol NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Carvedilol NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
CarvedilolCarvedilol 12.5 mg/1Tablet, Film coatedOralDirect_Rx72189-69072189-0690-90
CarvedilolCarvedilol 3.125 mg/1Tablet, Film coatedOralCoupler LLC67046-097367046-0973-03
CarvedilolCarvedilol 12.5 mg/1Tablet, Film coatedOralCoupler LLC67046-087967046-0879-03
CarvedilolCarvedilol 6.25 mg/1Tablet, Film coatedOralCoupler LLC67046-033667046-0336-03
CarvedilolCarvedilol 6.25 mg/1Tablet, Film coatedOralDirect_Rx72189-66472189-0664-60
CarvedilolCarvedilol 25 mg/1Tablet, Film coatedOralDirect_Rx72189-66372189-0663-90
CarvedilolCarvedilol 3.125 mg/1Tablet, Film coatedOralDirect_Rx72189-65372189-0653-90
CarvedilolCarvedilol 3.125 mg/1Tablet, Film coatedOralCoupler LLC67046-161667046-1616-03
CarvedilolCarvedilol 3.125 mg/1Tablet, Film coatedOralAdvagen Pharma Limited72888-49972888-0499-0172888-0499-0272888-0499-03
CarvedilolCarvedilol 6.25 mg/1Tablet, Film coatedOralAdvagen Pharma Limited72888-50072888-0500-0172888-0500-0272888-0500-03

All 168 Carvedilol NDCs

Other NDCs under ANDA 078332

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

FDA NDC Directory listings under ANDA 078332
ProductStrengthForm · routeLabelerProduct NDC
CarvedilolCarvedilol 12.5 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.43063-125
CarvedilolCarvedilol 3.125 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.43063-126
CarvedilolCarvedilol 25 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.43063-129
CarvedilolCarvedilol 6.25 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.43063-833
CarvedilolCarvedilol 25 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-1069
CarvedilolCarvedilol 12.5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-2079
CarvedilolCarvedilol 25 mg/1Tablet, Film coatedOralProficient Rx LP63187-409
CarvedilolCarvedilol 3.125 mg/1Tablet, Film coatedOralProficient Rx LP63187-941
CarvedilolCarvedilol 6.25 mg/1Tablet, Film coatedOralProficient Rx LP63187-946
CarvedilolCarvedilol 6.25 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-143
CarvedilolCarvedilol 12.5 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-144
CarvedilolCarvedilol 25 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-145
CarvedilolCarvedilol 6.25 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4600
CarvedilolCarvedilol 25 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0273
CarvedilolCarvedilol 3.125 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-132

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