NDC codes

FDA NDC Directory
Product NDC (as listed)60219-1420Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60219-1420Add 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
60219-1420-3602191420036021914200330 CAPSULE in 1 BOTTLE (60219-1420-3)Marketed from Dec 3, 2018
60219-1420-9602191420096021914200990 CAPSULE in 1 BOTTLE (60219-1420-9)Marketed from Dec 3, 2018

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)
Silodosin
Generic name (nonproprietary)
silodosin
Active ingredients
Silodosin — 8 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Amneal Pharmaceuticals NY LLCNDC labeler code 60219
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209745
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha-Antagonists (Mechanism)
Identifiers
Product ID 60219-1420_39f09c3f-1ddd-44fb-a71e-18d9a9486654SPL ID 39f09c3f-1ddd-44fb-a71e-18d9a9486654SPL set ID 455c98be-aa01-4393-915f-34d1859005c0RxCUI 809477, 826612UNII CUZ39LUY82
Pharmacologic class
alpha-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

N460219142003 followed by a unit qualifier and the quantity

Package 60219-1420-03. 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)

Silodosin, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14) ] . Silodosin capsules are not indicated for the treatment of hypertension. Silodosin, an alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Silodosin capsules are not indicated for the treatment of hypertension. (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 60219-1420

What is NDC 60219-1420?
60219-1420 is the product NDC for Silodosin, Silodosin 8 mg/1 capsule, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Silodosin.
What is the active ingredient?
Silodosin.
Who is the labeler?
Amneal Pharmaceuticals NY LLC, NDC labeler code 60219. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Silodosin?
28 other product NDCs are listed under this name. See all Silodosin 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 Silodosin NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
SilodosinSilodosin 4 mg/1CapsuleOralBryant Ranch Prepack72162-244672162-2446-03
SilodosinSilodosin 8 mg/1CapsuleOralBryant Ranch Prepack72162-244772162-2447-0372162-2447-09
SilodosinSilodosin 4 mg/1CapsuleOralCreekwood Pharmaceuticals LLC82619-11382619-0113-01
SilodosinSilodosin 8 mg/1CapsuleOralCreekwood Pharmaceuticals LLC82619-11482619-0114-0182619-0114-02
SilodosinSilodosin 4 mg/1CapsuleOralAvKARE42291-77742291-0777-30
SilodosinSilodosin 8 mg/1CapsuleOralAvKARE42291-77842291-0778-90
SilodosinSilodosin 4 mg/1CapsuleOralCamber Pharmaceuticals, Inc.31722-63531722-0635-3031722-0635-3131722-0635-90+1 more
SilodosinSilodosin 8 mg/1CapsuleOralCamber Pharmaceuticals, Inc.31722-63631722-0636-3031722-0636-3131722-0636-90+1 more
SilodosinSilodosin 4 mg/1CapsuleOralAlembic Pharmaceuticals Limited46708-40546708-0405-3046708-0405-9046708-0405-91
SilodosinSilodosin 8 mg/1CapsuleOralAlembic Pharmaceuticals Limited46708-40646708-0406-3046708-0406-9046708-0406-91

All 29 Silodosin NDCs

Other NDCs under ANDA 209745

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

FDA NDC Directory listings under ANDA 209745
ProductStrengthForm · routeLabelerProduct NDC
SilodosinSilodosin 4 mg/1CapsuleOralAvKARE42291-777
SilodosinSilodosin 8 mg/1CapsuleOralAvKARE42291-778
SilodosinSilodosin 4 mg/1CapsuleOralAmneal Pharmaceuticals NY LLC60219-1421
SilodosinSilodosin 8 mg/1CapsuleOralAmneal Pharmaceuticals NY LLC69238-1420
SilodosinSilodosin 4 mg/1CapsuleOralAmneal Pharmaceuticals NY LLC69238-1421

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