What is NDC 33342-384?

33342-384 is the product NDC for Silodosin, Silodosin 4 mg/1 capsule, listed with the FDA by Macleods Pharmaceuticals Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.

Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Silodosin NDC 33342-384 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-384Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0384Add 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 NDC	11-digit (billing)	Package
33342-384-07	3334203840733342038407	30 CAPSULE in 1 BOTTLE (33342-384-07)Marketed from Dec 3, 2018
33342-384-10	3334203841033342038410	90 CAPSULE in 1 BOTTLE (33342-384-10)Marketed from Dec 3, 2018
33342-384-12	3334203841233342038412	100 BLISTER PACK in 1 CARTON (33342-384-12) / 10 CAPSULE in 1 BLISTER PACKMarketed from Dec 3, 2018

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: Macleods Pharmaceuticals LimitedNDC labeler code 33342
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211166
Marketing start: Dec 3, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha-Antagonists (Mechanism)
Identifiers: Product ID 33342-384_4a96f732-bbce-426f-9780-89115cac638bSPL ID 4a96f732-bbce-426f-9780-89115cac638bSPL set ID 58af9a98-b1a1-4f30-b535-6647f1effed4RxCUI 809477, 826612UNII CUZ39LUY82UPC 0333342385109, 0333342385079, 0333342384102, 0333342384072
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

N433342038407 followed by a unit qualifier and the quantity

Package 33342-0384-07. 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 Jun 28, 2022.

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 is 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 is 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 33342-384

What is NDC 33342-384?: 33342-384 is the product NDC for Silodosin, Silodosin 4 mg/1 capsule, listed with the FDA by Macleods Pharmaceuticals Limited. It has 3 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?: Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Silodosin	Silodosin 4 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-2446	72162-2446-03
Silodosin	Silodosin 8 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-2447	72162-2447-0372162-2447-09
Silodosin	Silodosin 4 mg/1	CapsuleOral	Creekwood Pharmaceuticals LLC	82619-113	82619-0113-01
Silodosin	Silodosin 8 mg/1	CapsuleOral	Creekwood Pharmaceuticals LLC	82619-114	82619-0114-0182619-0114-02
Silodosin	Silodosin 4 mg/1	CapsuleOral	AvKARE	42291-777	42291-0777-30
Silodosin	Silodosin 8 mg/1	CapsuleOral	AvKARE	42291-778	42291-0778-90
Silodosin	Silodosin 4 mg/1	CapsuleOral	Camber Pharmaceuticals, Inc.	31722-635	31722-0635-3031722-0635-3131722-0635-90+1 more
Silodosin	Silodosin 8 mg/1	CapsuleOral	Camber Pharmaceuticals, Inc.	31722-636	31722-0636-3031722-0636-3131722-0636-90+1 more
Silodosin	Silodosin 4 mg/1	CapsuleOral	Alembic Pharmaceuticals Limited	46708-405	46708-0405-3046708-0405-9046708-0405-91
Silodosin	Silodosin 8 mg/1	CapsuleOral	Alembic Pharmaceuticals Limited	46708-406	46708-0406-3046708-0406-9046708-0406-91

All 29 Silodosin NDCs

Other NDCs under ANDA 211166

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

FDA NDC Directory listings under ANDA 211166
Product	Strength	Form · route	Labeler	Product NDC
Silodosin	Silodosin 8 mg/1	CapsuleOral	Macleods Pharmaceuticals Limited	33342-385
Silodosin	Silodosin 8 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-3128