TAMSULOSIN HYDROCHLORIDE

Product NDC: 10544-550
11-digit product format: 105440550
Labeler code: 10544
Product ID: 10544-550_84e4e4aa-fd78-42af-b677-c0d921033059
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TAMSULOSIN HYDROCHLORIDE
Dosage form: CAPSULE
Route: ORAL
Labeler: Blenheim Pharmacal, Inc.
Application: ANDA078938
Marketing category: ANDA
Marketing start: 2013-10-07
Marketing end: 0000-00-00
Substance: TAMSULOSIN HYDROCHLORIDE
Active strength: 0 mg/1
Pharmacologic classes: Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ee39297f-c54b-4394-13fa-e0de7b5b9070	Product name	4	20250305
ae349df8-97ce-a639-ed32-50a4cb01b1bd	Product name	4	20200313

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10544-550-30	2020-01-31	C162847	48780-1	9d75b9d0-d16b-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use tamsulosin hydrochloride safely and effectively. See full prescribing information for tamsulosin hydrochloride. Tamsulosin Hydrochloride Capsules USP*, 0.4 mg Initial U.S. Approval: 1997

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10544-550-30	TAMSULOSIN HYDROCHLORIDE	30 in 1 BOTTLE	CAPSULE	30		2

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
TAMSULOSIN HYDROCHLORIDE	ACTIVE INGREDIENT	11SV1951MR	TAMSULOSIN HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]	2
TAMSULOSIN	ACTIVE MOIETY	G3P28OML5I	TAMSULOSIN HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]	2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10544-550	TAMSULOSIN HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]	2	Legacy NDC, 1 package rows	20151023_a19b13a1-74a4-42da-80d1-d7c996445c26.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
11SV1951MR	TAMSULOSIN HYDROCHLORIDE	106463-17-6	TAMSULOSIN HYDROCHLORIDE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
863669	tamsulosin HCl 0.4 MG Oral Capsule	PSN	a19b13a1-74a4-42da-80d1-d7c996445c26	2
863669	tamsulosin hydrochloride 0.4 MG Oral Capsule	SCD	a19b13a1-74a4-42da-80d1-d7c996445c26	2
863669	tamsulosin HCl 0.4 MG Modified Release Oral Capsule	SY	a19b13a1-74a4-42da-80d1-d7c996445c26	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10544-550-30	10544055030	30 in 1 BOTTLE	Historical