TAMSULOSIN HYDROCHLORIDE

Product NDC: 42254-012
11-digit product format: 422540012
Labeler code: 42254
Product ID: 42254-012_1ceb560b-1a62-408d-8e30-23113e8c9dd3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TAMSULOSIN HYDROCHLORIDE
Dosage form: CAPSULE
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA078938
Marketing category: ANDA
Marketing start: 2010-04-27
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
42254-012-30	2019-09-24	C162847	48780-1	9350213a-3dc1-c013-e053-90daa90a1393	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
42254-012-30	TAMSULOSIN HYDROCHLORIDE	30 in 1 BOTTLE	CAPSULE	30		1

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42254-012-30	EA - Each	42254-012	4af849ac-766e-4dd5-bd88-1c3d37d9d9ef	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
TAMSULOSIN HYDROCHLORIDE	ACTIVE INGREDIENT	11SV1951MR	TAMSULOSIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	1
TAMSULOSIN	ACTIVE MOIETY	G3P28OML5I	TAMSULOSIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42254-012	TAMSULOSIN HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20120103_1ceb560b-1a62-408d-8e30-23113e8c9dd3.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	1ceb560b-1a62-408d-8e30-23113e8c9dd3	1
863669	tamsulosin hydrochloride 0.4 MG Oral Capsule	SCD	1ceb560b-1a62-408d-8e30-23113e8c9dd3	1
863669	tamsulosin HCl 0.4 MG Modified Release Oral Capsule	SY	1ceb560b-1a62-408d-8e30-23113e8c9dd3	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
42254-012-30	42254001230	30 in 1 BOTTLE	Historical