NDC 0378-2500-93 - Tamsulosin Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 0378-2500
Requested NDC: 0378-2500-93
Package NDCs from labels: 0378-2500-77, 0378-2500-10, 0378-2500-93
Manufacturer: Mylan Institutional Inc.
Effective date: 2018-12-21
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Tamsulosin Hydrochloride - Mylan Institutional Inc.	Mylan Institutional Inc.	2018-12-21	HUMAN PRESCRIPTION DRUG LABEL
Tamsulosin Hydrochloride - Aphena Pharma Solutions - Tennessee, LLC	Aphena Pharma Solutions - Tennessee, LLC	2017-10-26	HUMAN PRESCRIPTION DRUG LABEL
Tamsulosin Hydrochloride - NCS HealthCare of KY, Inc dba Vangard Labs	NCS HealthCare of KY, Inc dba Vangard Labs	2015-11-13	HUMAN PRESCRIPTION DRUG LABEL
Tamsulosin Hydrochloride - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2015-10-26	HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2012-07-24	Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-2500-10	EA - Each	0378-2500	9cebc1b8-44ff-4047-bdd8-485574b7f9be	1	2012-07-24
0378-2500-77	EA - Each	0378-2500	6a8ad7d1-b236-4575-ac13-bdb9fc21b54a	1	2012-07-24
0378-2500-93	EA - Each	0378-2500	748a4959-ae1c-461c-868a-c464ea2ab4f7	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TAMSULOSIN HYDROCHLORIDE	ACTIVE INGREDIENT	11SV1951MR	TAMSULOSIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	8
TAMSULOSIN	ACTIVE MOIETY	G3P28OML5I	TAMSULOSIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	8
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	TAMSULOSIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TAMSULOSIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	8
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	TAMSULOSIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	8
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	TAMSULOSIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	8
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	TAMSULOSIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	8
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	TAMSULOSIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	8
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	TAMSULOSIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	8
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TAMSULOSIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	8
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TAMSULOSIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	8
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	TAMSULOSIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	8
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	TAMSULOSIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	8
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TAMSULOSIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	8
SHELLAC	INACTIVE INGREDIENT	46N107B71O	TAMSULOSIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	8
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	TAMSULOSIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	8
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TAMSULOSIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	8
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TAMSULOSIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TAMSULOSIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	8
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	TAMSULOSIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]	8
TAMSULOSIN HYDROCHLORIDE	ACTIVE INGREDIENT	11SV1951MR	TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
TAMSULOSIN	ACTIVE MOIETY	G3P28OML5I	TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
SHELLAC	INACTIVE INGREDIENT	46N107B71O	TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
TAMSULOSIN HYDROCHLORIDE	ACTIVE INGREDIENT	11SV1951MR	TAMSULOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
TAMSULOSIN	ACTIVE MOIETY	G3P28OML5I	TAMSULOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	TAMSULOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TAMSULOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	TAMSULOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	TAMSULOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	TAMSULOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	TAMSULOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	TAMSULOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TAMSULOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TAMSULOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	TAMSULOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	TAMSULOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TAMSULOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
SHELLAC	INACTIVE INGREDIENT	46N107B71O	TAMSULOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	TAMSULOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TAMSULOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TAMSULOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TAMSULOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	TAMSULOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	4

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 7 of 108 · 2,158 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 0N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	43599d17-81f4-4c6e-b6bd-d1e700b668ee	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 0.5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	116f09db-f859-40c5-8857-33503903ee76	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	480e5bf9-8e24-4335-a434-93255ceb640e	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1.5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	7057feab-20fe-4547-8223-0816904bcfd6	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1CR Cool Rosy	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	672a804d-ba8e-4c03-91fc-3edc0b12c627	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 3.5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b656394d-a410-4f8c-a632-815a349fb17e	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 6.5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	4d47292f-35f2-4e9f-a9d8-2df57cbe92cf	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 7N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	96258152-5255-4f04-9a35-c5a76b9c0520	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 3W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	5df158da-3280-4ce6-a04c-370999343400	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2.5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	be60feb0-8c16-4ef6-a36f-423ed18e098c	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 3N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	2d7678b4-b082-4911-80a2-c019eb529414	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 9N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	00c9da7c-d4c7-49da-afa9-1fde93a81540	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	201acd8e-23c6-43fd-81dc-a814c3d8160b	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 8N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b24806b1-d9da-4373-b072-6d9a262ea365	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	c981ae5e-e7e8-484b-b682-fb96d501e03b	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
PREMIUM BEAUTY BALM BROAD SPECTRUM SPF 30	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, AND ZINC OXIDE	Have & Be Co., Ltd.	4a7e868d-6310-6ee4-e063-6394a90aebce	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	53a79ee7-312b-49a2-8a9b-c50794fcd171	2026-05-05	Warnings	Exact identifier unii: 15FIX9V2JP
Neutrogena MINERAL UV TINT FACE DEEP SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Port Jervis Laboratories, Inc	51169bed-2091-ad2b-e063-6294a90a84b6	2026-05-05	Warnings	Exact identifier unii: 15FIX9V2JP
LUMINOUS EYE CORRECTOR SPF 41 - FAIR	TITANIUM DIOXIDE, ZINC OXIDE	Drmtlgy, LLC	8cfb1f8c-1bd7-4983-ab82-1c9bd8925afa	2026-05-04	Warnings	Exact identifier unii: 15FIX9V2JP
LUMINOUS EYE CORRECTOR SPF 41 - DEEP	TITANIUM DIOXIDE, ZINC OXIDE	Drmtlgy, LLC	930bd1de-5a0e-4607-8d3c-b1ca918f890b	2026-05-04	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.