NDC codes

FDA NDC Directory
Product NDC (as listed)63629-9414Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-9414Add 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
63629-9414-16362994140190 TABLET, FILM COATED in 1 BOTTLE (63629-9414-1)Marketed from Jul 27, 2022
63629-9414-26362994140230 TABLET, FILM COATED in 1 BOTTLE (63629-9414-2)Marketed from Jul 27, 2022

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)
Eplerenone
Generic name (nonproprietary)
eplerenone
Active ingredients
Eplerenone — 25 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 63629
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206922
Marketing start
Listing expires
Other FDA classes
Aldosterone Antagonists (Mechanism)
Identifiers
Product ID 63629-9414_cddd14b9-541c-4a14-9241-11c513bda59dSPL ID cddd14b9-541c-4a14-9241-11c513bda59dSPL set ID bcd7595f-700f-48ba-bf83-05a995ce0731RxCUI 351256UNII 6995V82D0B
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

N463629941401 followed by a unit qualifier and the quantity

Package 63629-9414-01. 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)

Eplerenone is an aldosterone antagonist indicated 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 infarctio( 1.2 ) 1.2 Hypertension Eplerenone tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and MI. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. Control of high blood pressure should be part of comprehensive CV risk management, including, as approp…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63629-9414

What is NDC 63629-9414?
63629-9414 is the product NDC for Eplerenone, Eplerenone 25 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Eplerenone.
What is the active ingredient?
Eplerenone.
Who is the labeler?
Bryant Ranch Prepack, NDC labeler code 63629. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Eplerenone?
18 other product NDCs are listed under this name. See all Eplerenone 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 Eplerenone NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
EplerenoneEplerenone 25 mg/1Tablet, Film coatedOralMylan Pharmaceuticals Inc.59762-110759762-1107-0259762-1107-03
EplerenoneEplerenone 50 mg/1Tablet, Film coatedOralMylan Pharmaceuticals Inc.59762-110859762-1108-0159762-1108-02
EplerenoneEplerenone 25 mg/1TabletOralRising Pharma Holdings, Inc.16571-17316571-0173-0316571-0173-09
EplerenoneEplerenone 50 mg/1TabletOralRising Pharma Holdings, Inc.16571-17416571-0174-0316571-0174-09
EplerenoneEplerenone 25 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-04931722-0049-3031722-0049-90
EplerenoneEplerenone 50 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-05031722-0050-3031722-0050-90
EplerenoneEplerenone 25 mg/1Tablet, CoatedOralAvKARE42291-45442291-0454-90
EplerenoneEplerenone 50 mg/1Tablet, CoatedOralAvKARE42291-45542291-0455-90
EplerenoneEplerenone 25 mg/1Tablet, CoatedOralWestminster Pharmaceuticals, LLC69367-30769367-0307-0969367-0307-30
EplerenoneEplerenone 50 mg/1Tablet, CoatedOralWestminster Pharmaceuticals, LLC69367-30869367-0308-0969367-0308-30

All 19 Eplerenone NDCs

Other NDCs under ANDA 206922

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

FDA NDC Directory listings under ANDA 206922
ProductStrengthForm · routeLabelerProduct NDC
EplerenoneEplerenone 25 mg/1Tablet, Film coatedOralAccord Healthcare, Inc.16729-293
EplerenoneEplerenone 50 mg/1Tablet, Film coatedOralAccord Healthcare, Inc.16729-294

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