NDC codes

FDA NDC Directory
Product NDC (as listed)82619-113Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82619-0113Add 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
82619-113-01826190113018261901130130 CAPSULE in 1 BOTTLE (82619-113-01)Marketed from Nov 14, 2024

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)
Silodosin
Generic name (nonproprietary)
silodosin
Active ingredients
Silodosin — 4 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Creekwood Pharmaceuticals LLCNDC labeler code 82619
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 213230
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha-Antagonists (Mechanism)
Identifiers
Product ID 82619-113_51397c86-1c54-06a7-e063-6394a90a1ff3SPL ID 51397c86-1c54-06a7-e063-6394a90a1ff3SPL set ID 43f83422-680f-411e-bbc3-2b092e64a017RxCUI 809477, 826612UNII CUZ39LUY82UPC 0382619114010, 0382619114027, 0382619113013
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

N482619011301 followed by a unit qualifier and the quantity

Package 82619-0113-01. 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)

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 is not indicated for the treatment of hypertension. Silodosin capsules, 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 82619-113

What is NDC 82619-113?
82619-113 is the product NDC for Silodosin, Silodosin 4 mg/1 capsule, listed with the FDA by Creekwood Pharmaceuticals LLC. It has 1 package NDC, 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?
Creekwood Pharmaceuticals LLC, NDC labeler code 82619. 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 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
SilodosinSilodosin 4 mg/1CapsuleOralAlembic Pharmaceuticals Inc.62332-40562332-0405-3062332-0405-9062332-0405-91

All 29 Silodosin NDCs

Other NDCs under ANDA 213230

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

FDA NDC Directory listings under ANDA 213230
ProductStrengthForm · routeLabelerProduct NDC
SilodosinSilodosin 4 mg/1CapsuleOralBryant Ranch Prepack72162-2446
SilodosinSilodosin 8 mg/1CapsuleOralBryant Ranch Prepack72162-2447
SilodosinSilodosin 8 mg/1CapsuleOralCreekwood Pharmaceuticals LLC82619-114

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