tamsulosin hydrochloride

Product NDC: 0781-2076
11-digit product format: 007812076
Labeler code: 0781
Product ID: 0781-2076_98c2abd9-1998-48cd-83f9-f5f94ff39345
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tamsulosin hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Sandoz Inc
Application: ANDA078015
Marketing category: ANDA
Marketing start: 2010-04-27
Substance: TAMSULOSIN HYDROCHLORIDE
Active strength: .4 mg/1
Pharmacologic classes: Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078015-001	TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL			2010-04-27

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078015-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL		2010-04-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078015-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078015-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078015-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078015-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078015-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078015-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078015-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078015-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078015-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078015-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078015-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078015-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078015-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078015-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078015-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078015-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078015-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078015-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078015-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078015-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078015-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078015-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078015-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078015-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078015-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078015-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078015-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078015-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078015-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078015-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078015-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078015-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078015-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078015-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078015-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078015-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078015-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078015-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078015-001	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE / ORAL	AB	2010-04-27	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078015-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078015-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078015-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078015-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078015-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078015-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078015-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078015-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078015-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078015-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078015-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078015-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078015-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078015-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078015-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078015-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078015-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078015-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078015-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078015-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078015-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078015-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078015-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078015-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078015-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078015-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078015-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078015-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078015-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078015-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078015-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078015-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078015-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078015-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078015-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078015-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078015-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078015-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078015-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078015-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: tamsulosin hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TAMSULOSIN HYDROCHLORIDE	.4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
11SV1951MR	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
863669	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
fb120098-b007-4a33-80b8-b7279c7668ee	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0781-2076-01	tamsulosin hydrochloride	100 in 1 BOTTLE	CAPSULE	100	10
0781-2076-10	tamsulosin hydrochloride	1000 in 1 BOTTLE	CAPSULE	1000	10
0781-2076-92	tamsulosin hydrochloride	90 in 1 BOTTLE	CAPSULE	90	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-2076-01	EA - Each	0781-2076	9872e83c-cc49-494f-8cd2-97975764b34e	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 [SANDOZ INC]	6
TAMSULOSIN	ACTIVE MOIETY	G3P28OML5I	TAMSULOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TAMSULOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]	6
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)	INACTIVE INGREDIENT	P2OM2Q86BI	TAMSULOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]	6
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	TAMSULOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]	6
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	TAMSULOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]	6
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	TAMSULOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]	6
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TAMSULOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]	6
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TAMSULOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]	6
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	TAMSULOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]	6
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	TAMSULOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]	6
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TAMSULOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]	6
SHELLAC	INACTIVE INGREDIENT	46N107B71O	TAMSULOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TAMSULOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]	6
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TAMSULOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TAMSULOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TAMSULOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]	6
TAMSULOSIN HYDROCHLORIDE	ACTIVE INGREDIENT	11SV1951MR	TAMSULOSIN HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	2
TAMSULOSIN	ACTIVE MOIETY	G3P28OML5I	TAMSULOSIN HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TAMSULOSIN HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	2
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)	INACTIVE INGREDIENT	P2OM2Q86BI	TAMSULOSIN HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	TAMSULOSIN HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	TAMSULOSIN HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	TAMSULOSIN HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TAMSULOSIN HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TAMSULOSIN HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	TAMSULOSIN HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	TAMSULOSIN HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TAMSULOSIN HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	TAMSULOSIN HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TAMSULOSIN HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TAMSULOSIN HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TAMSULOSIN HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TAMSULOSIN HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0781-2076	TAMSULOSIN HYDROCHLORIDE CAPSULE [SANDOZ INC]	9	Current NDC, Legacy NDC, 3 package rows	20201124_fb120098-b007-4a33-80b8-b7279c7668ee.zip

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
tamsulosin hydrochloride	TAMSULOSIN HYDROCHLORIDE	Sandoz Inc	fb120098-b007-4a33-80b8-b7279c7668ee	2024-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078015 application number: ANDA078015 ndc (product): 0781-2076

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
863669	tamsulosin HCl 0.4 MG Oral Capsule	PSN	fb120098-b007-4a33-80b8-b7279c7668ee	10
863669	tamsulosin hydrochloride 0.4 MG Oral Capsule	SCD	fb120098-b007-4a33-80b8-b7279c7668ee	10
863669	tamsulosin HCl 0.4 MG Modified Release Oral Capsule	SY	fb120098-b007-4a33-80b8-b7279c7668ee	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-2076-01	00781207601	100 CAPSULE in 1 BOTTLE (0781-2076-01)	100 capsule	2010-04-27	0000-00-00	No	No	Current
0781-2076-10	00781207610	1000 CAPSULE in 1 BOTTLE (0781-2076-10)	1000 capsule	2010-04-27	0000-00-00	No	No	Current
0781-2076-92	00781207692	90 CAPSULE in 1 BOTTLE (0781-2076-92)	90 capsule	2019-01-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
tamsulosin hydrochloride	Sandoz Inc	2024-09-30	HUMAN PRESCRIPTION DRUG LABEL	10
tamsulosin hydrochloride	Major Pharmaceuticals	2024-06-26	HUMAN PRESCRIPTION DRUG LABEL	8