What is NDC 33342-159?

33342-159 is the product NDC for Tamsulosin Hydrochloride, Tamsulosin hydrochloride .4 mg/1 capsule, listed with the FDA by Macleods Pharmaceuticals Limited. It has 5 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 Tamsulosin Hydrochloride?

61 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tamsulosin Hydrochloride NDC 33342-159

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-159Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0159Add 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
33342-159-07	3334201590733342015907	30 CAPSULE in 1 BOTTLE (33342-159-07)Marketed from Jan 25, 2017
33342-159-11	3334201591133342015911	100 CAPSULE in 1 BOTTLE (33342-159-11)Marketed from Jan 25, 2017
33342-159-12	3334201591233342015912	10 BLISTER PACK in 1 CARTON (33342-159-12) / 10 CAPSULE in 1 BLISTER PACKMarketed from Jan 25, 2017
33342-159-15	3334201591533342015915	500 CAPSULE in 1 BOTTLE (33342-159-15)Marketed from Jan 25, 2017
33342-159-44	3334201594433342015944	1000 CAPSULE in 1 BOTTLE (33342-159-44)Marketed from Jan 25, 2017

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): Tamsulosin Hydrochloride
Generic name (nonproprietary): tamsulosin hydrochloride
Active ingredients: Tamsulosin hydrochloride — .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 204645
Marketing start: Jan 25, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha-Antagonists (Mechanism)
Identifiers: Product ID 33342-159_95b0ff14-97b3-4b8c-8545-f066a45c2f82SPL ID 95b0ff14-97b3-4b8c-8545-f066a45c2f82SPL set ID 2912fbbc-89bf-4bf0-86fe-bd98f3168e84RxCUI 863669UNII 11SV1951MRUPC 0333342159106, 0333342159113
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

N433342015907 followed by a unit qualifier and the quantity

Package 33342-0159-07. 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 Nov 30, 2022.

Indications (excerpt from the label)

Tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies ( 14 )]. Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension. • Tamsulosin hydrochloride is an alpha 1 adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia ( 1 ) • Tamsulosin hydrochloride 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 33342-159

What is NDC 33342-159?: 33342-159 is the product NDC for Tamsulosin Hydrochloride, Tamsulosin hydrochloride .4 mg/1 capsule, listed with the FDA by Macleods Pharmaceuticals Limited. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tamsulosin Hydrochloride.
What is the active ingredient?: Tamsulosin hydrochloride.
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 Tamsulosin Hydrochloride?: 61 other product NDCs are listed under this name. See all Tamsulosin Hydrochloride 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 Tamsulosin Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Tamsulosin Hydrochloride	Tamsulosin hydrochloride .4 mg/1	CapsuleOral	Preferred Pharmaceuticals Inc.	68788-4145	68788-4145-0168788-4145-0368788-4145-06+2 more
Tamsulosin Hydrochloride	Tamsulosin hydrochloride .4 mg/1	CapsuleOral	Coupler LLC	67046-1015	67046-1015-03
tamsulosin hydrochloride	Tamsulosin hydrochloride .4 mg/1	CapsuleOral	XLCare Pharmaceuticals, Inc.	72865-350	72865-0350-0572865-0350-90
Tamsulosin Hydrochloride	Tamsulosin hydrochloride .4 mg/1	CapsuleOral	AvKARE	42291-989	42291-0989-1042291-0989-90
Tamsulosin Hydrochloride	Tamsulosin hydrochloride .4 mg/1	CapsuleOral	Amneal Pharmaceuticals of New York LLC	0115-8211	00115-8211-01
Tamsulosin Hydrochloride	Tamsulosin hydrochloride .4 mg/1	CapsuleOral	Cardinal Health 107, LLC	55154-2142	55154-2142-00
Tamsulosin Hydrochloride	Tamsulosin hydrochloride .4 mg/1	CapsuleOral	Cardinal Health 107, LLC	55154-2636	55154-2636-00
Tamsulosin Hydrochloride	Tamsulosin hydrochloride .4 mg/1	CapsuleOral	XLCare Pharmaceuticals, Inc	72865-282	72865-0282-0172865-0282-0572865-0282-90
Tamsulosin hydrochloride	Tamsulosin hydrochloride .4 mg/1	CapsuleOral	Aphena Pharma Solutions - Tennessee, LLC	71610-910	71610-0910-3071610-0910-5371610-0910-60+2 more
Tamsulosin hydrochloride	Tamsulosin hydrochloride .4 mg/1	CapsuleOral	EXELAN PHARMACEUTICALS, INC.	76282-744	76282-0744-0576282-0744-90

All 62 Tamsulosin Hydrochloride NDCs

Other NDCs under ANDA 204645

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

FDA NDC Directory listings under ANDA 204645
Product	Strength	Form · route	Labeler	Product NDC
Tamsulosin Hydrochloride	Tamsulosin hydrochloride .4 mg/1	CapsuleOral	NuCare Pharmaceuticals,Inc.	68071-1840
Tamsulosin Hydrochloride	Tamsulosin hydrochloride .4 mg/1	CapsuleOral	NuCare Pharmaceuticals,Inc.	68071-4872
Tamsulosin Hydrochloride	Tamsulosin hydrochloride .4 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-2502