NDC codes

FDA NDC Directory
Product NDC (as listed)62559-149Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62559-0149Add 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
62559-149-0162559014901100 TABLET in 1 BOTTLE (62559-149-01)Marketed from Dec 22, 2010

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

Generic name (nonproprietary)
esterified estrogens and methyltestosterone
Active ingredients
Estrogens, Esterified — 1.25 mg/1Methyltestosterone — 2.5 mg/1
Dosage form
Tablet
Route
Oral
Labeler
ANI Pharmaceuticals, Inc.NDC labeler code 62559
Product type
Prescription drug
Marketing category
Unapproved drug (other)
Marketing start
Listing expires
DEA schedule
CIII
Other FDA classes
Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
Identifiers
Product ID 62559-149_027e7148-2471-49b5-9fea-88d7c2d7684cSPL ID 027e7148-2471-49b5-9fea-88d7c2d7684cSPL set ID d42eeda8-d810-4481-a403-6a3520b9e69aRxCUI 197670, 238006UNII V9EFU16ZIF, 3ASP8Q3768UPC 0362559149013, 0362559150019
Pharmacologic class
Androgen

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

N462559014901 followed by a unit qualifier and the quantity

Package 62559-0149-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Esterified Estrogens and Methyltestosterone Full and Half-Strength Tablets are indicated in the: • Treatment of moderate to severe vasomotor symptoms associated with the menopause in those patients not improved by estrogens alone. (There is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.) • Esterified Estrogens and Methyltestosterone Full and Half-Strength Tablets have not been shown to be effective for any purpose during pregnancy and its use may cause severe harm to the fetus.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 62559-149

What is NDC 62559-149?
62559-149 is the product NDC for Esterified Estrogens and Methyltestosterone, Estrogens, Esterified 1.25 mg/1; Methyltestosterone 2.5 mg/1 tablet, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Esterified Estrogens and Methyltestosterone.
What is the active ingredient?
Estrogens, Esterified, Methyltestosterone.
Who is the labeler?
ANI Pharmaceuticals, Inc., NDC labeler code 62559. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Esterified Estrogens and Methyltestosterone?
17 other product NDCs are listed under this name. See all Esterified Estrogens and Methyltestosterone 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 Esterified Estrogens and Methyltestosterone NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Esterified Estrogens And Methyltestosteroneesterified estrogens, methyltestosteroneEstrogens, Esterified 1.25 mg/1; Methyltestosterone 2.5 mg/1TabletOralBryant Ranch Prepack72162-239372162-2393-01
Esterified Estrogens And Methyltestosteroneesterified estrogens, methyltestosteroneEstrogens, Esterified .625 mg/1; Methyltestosterone 1.25 mg/1TabletOralMethod Pharmaceuticals, LLC58657-40758657-0407-01
Esterified Estrogens And Methyltestosteroneesterified estrogens, methyltestosteroneEstrogens, Esterified 1.25 mg/1; Methyltestosterone 2.5 mg/1TabletOralMethod Pharmaceuticals, LLC58657-40858657-0408-01
Esterified Estrogens and Methyltestosteroneesterified estrogens, methyltestosteroneEstrogens, Esterified .625 mg/1; Methyltestosterone 1.25 mg/1TabletOralSTATUS PROJECTS PRIVATE LIMITED84346-45084346-0450-01
Esterified Estrogens And Methyltestosteroneesterified estrogens, methyltestosteroneEstrogens, Esterified .625 mg/1; Methyltestosterone 1.25 mg/1TabletOralLeading Pharmaceuticals, LLC69315-28369315-0283-01
Esterified Estrogens And Methyltestosteroneesterified estrogens, methyltestosteroneEstrogens, Esterified 1.25 mg/1; Methyltestosterone 2.5 mg/1TabletOralLeading Pharmaceuticals, LLC69315-28469315-0284-01
Esterified Estrogens and MethyltestosteroneEstrogens, Esterified .625 mg/1; Methyltestosterone 1.25 mg/1TabletOralBryant Ranch Prepack63629-917863629-9178-01
Esterified Estrogens and MethyltestosteroneEstrogens, Esterified .625 mg/1; Methyltestosterone 1.25 mg/1TabletOralECI Pharmaceuticals LLC51293-63951293-0639-01
Esterified Estrogens and MethyltestosteroneEstrogens, Esterified 1.25 mg/1; Methyltestosterone 2.5 mg/1TabletOralECI Pharmaceuticals LLC51293-64051293-0640-01
Esterified Estrogens and MethyltestosteroneEstrogens, Esterified 1.25 mg/1; Methyltestosterone 2.5 mg/1TabletOralBryant Ranch Prepack72162-174772162-1747-01

All 18 Esterified Estrogens and Methyltestosterone NDCs

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