NDC codes

FDA NDC Directory
Product NDC (as listed)69238-2577Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69238-2577Add 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
69238-2577-16923825770169238257701100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-2577-1)Marketed from Aug 1, 2023
69238-2577-269238257702692382577021000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-2577-2)Marketed from Aug 1, 2023
69238-2577-3692382577036923825770330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-2577-3)Marketed from Aug 1, 2023
69238-2577-9692382577096923825770990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-2577-9)Marketed from Aug 1, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 Phosphate
Generic name (nonproprietary)
carvedilol phosphate
Active ingredients
Carvedilol phosphate — 10 mg/1
Dosage form
Capsule, Extended release
Route
Oral
Labeler
Amneal Pharmaceuticals NY LLCNDC labeler code 69238
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204717
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha-Antagonists (Mechanism)Adrenergic beta1-Antagonists (Mechanism)Adrenergic beta2-Antagonists (Mechanism)
Identifiers
Product ID 69238-2577_7bae176f-58e3-4d75-9609-80079f391e1eSPL ID 7bae176f-58e3-4d75-9609-80079f391e1eSPL set ID dbec7c4b-3db7-4c9d-b5da-e72050ee5743RxCUI 860510, 860516, 860522, 860532UNII EQT531S367
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

N469238257701 followed by a unit qualifier and the quantity

Package 69238-2577-01. 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 .

Indications (excerpt from the label)

Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: mild to severe chronic heart failure. ( 1.1 ) left ventricular dysfunction following myocardial infarction in clinically stable patients. ( 1.2 ) hypertension. ( 1.3 ) 1.1 Heart Failure Carvedilol phosphate extended-release capsules are indicated for the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE inhibitors, and digitalis, to increase survival and, also, to reduce the risk of hospitalization [see Drug Interactions (7.4) , Clinical Studies (14.1) ]. 1.2 Left Ventricular Dysfunction follow…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69238-2577

What is NDC 69238-2577?
69238-2577 is the product NDC for Carvedilol Phosphate, Carvedilol phosphate 10 mg/1 capsule, extended release, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Carvedilol Phosphate.
What is the active ingredient?
Carvedilol phosphate.
Who is the labeler?
Amneal Pharmaceuticals NY LLC, NDC labeler code 69238. 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 Phosphate?
28 other product NDCs are listed under this name. See all Carvedilol Phosphate 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 Phosphate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Carvedilol PhosphateCarvedilol phosphate 10 mg/1Capsule, Extended releaseOralCoupler LLC67046-155167046-1551-03
Carvedilol PhosphateCarvedilol phosphate 10 mg/1Capsule, Extended releaseOralAvKARE42291-47942291-0479-30
Carvedilol PhosphateCarvedilol phosphate 20 mg/1Capsule, Extended releaseOralAvKARE42291-48042291-0480-30
Carvedilol PhosphateCarvedilol phosphate 40 mg/1Capsule, Extended releaseOralAvKARE42291-48142291-0481-30
Carvedilol PhosphateCarvedilol phosphate 80 mg/1Capsule, Extended releaseOralAvKARE42291-48242291-0482-30
Carvedilol PhosphateCarvedilol phosphate 10 mg/1Capsule, Extended releaseOralAmneal Pharmaceuticals of New York LLC0115-124800115-1248-0100115-1248-0300115-1248-08+1 more
Carvedilol PhosphateCarvedilol phosphate 20 mg/1Capsule, Extended releaseOralAmneal Pharmaceuticals of New York LLC0115-124900115-1249-0100115-1249-0300115-1249-08+1 more
Carvedilol PhosphateCarvedilol phosphate 40 mg/1Capsule, Extended releaseOralAmneal Pharmaceuticals of New York LLC0115-125000115-1250-0100115-1250-0300115-1250-08+1 more
Carvedilol PhosphateCarvedilol phosphate 80 mg/1Capsule, Extended releaseOralAmneal Pharmaceuticals of New York LLC0115-125100115-1251-0100115-1251-0300115-1251-08+1 more
Carvedilol PhosphateCarvedilol phosphate 20 mg/1Capsule, Extended releaseOralAmneal Pharmaceuticals NY LLC69238-257869238-2578-0169238-2578-0269238-2578-03+1 more

All 29 Carvedilol Phosphate NDCs

Other NDCs under ANDA 204717

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

FDA NDC Directory listings under ANDA 204717
ProductStrengthForm · routeLabelerProduct NDC
Carvedilol PhosphateCarvedilol phosphate 20 mg/1Capsule, Extended releaseOralAmneal Pharmaceuticals NY LLC69238-2578
Carvedilol PhosphateCarvedilol phosphate 40 mg/1Capsule, Extended releaseOralAmneal Pharmaceuticals NY LLC69238-2579
Carvedilol PhosphateCarvedilol phosphate 80 mg/1Capsule, Extended releaseOralAmneal Pharmaceuticals NY LLC69238-2580
Carvedilol PhosphateCarvedilol phosphate 10 mg/1Capsule, Extended releaseOralAvKARE42291-479
Carvedilol PhosphateCarvedilol phosphate 20 mg/1Capsule, Extended releaseOralAvKARE42291-480
Carvedilol PhosphateCarvedilol phosphate 40 mg/1Capsule, Extended releaseOralAvKARE42291-481
Carvedilol PhosphateCarvedilol phosphate 80 mg/1Capsule, Extended releaseOralAvKARE42291-482
Carvedilol PhosphateCarvedilol phosphate 10 mg/1Capsule, Extended releaseOralAmneal Pharmaceuticals of New York LLC0115-1248
Carvedilol PhosphateCarvedilol phosphate 20 mg/1Capsule, Extended releaseOralAmneal Pharmaceuticals of New York LLC0115-1249
Carvedilol PhosphateCarvedilol phosphate 40 mg/1Capsule, Extended releaseOralAmneal Pharmaceuticals of New York LLC0115-1250
Carvedilol PhosphateCarvedilol phosphate 80 mg/1Capsule, Extended releaseOralAmneal Pharmaceuticals of New York LLC0115-1251

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