Home NDC 10544-289 Terazosin
Product NDC 10544-289
11-digit product format 105440289
Labeler code 10544
Product ID 10544-289_0f547137-d43b-15f6-e054-00144ff8d46c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Terazosin
Dosage form CAPSULE
Route ORAL
Labeler Blenheim Pharmacal, Inc.
Application ANDA075498
Marketing category ANDA
Marketing start 2013-11-18
Marketing end 0000-00-00
Substance TERAZOSIN HYDROCHLORIDE
Active strength 10 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 2 · 66 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075498-001 TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL 2001-04-12 A075498-002 TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL 2001-04-12 A075498-003 TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL 2001-04-12 A075498-004 TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2001-04-12
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 5 · 164 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A075498-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL 2001-04-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075498-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL 2001-04-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075498-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL 2001-04-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075498-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2001-04-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075498-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL 2001-04-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075498-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL 2001-04-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075498-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL 2001-04-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075498-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2001-04-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075498-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL 2001-04-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075498-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL 2001-04-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075498-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL 2001-04-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075498-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2001-04-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075498-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL 2001-04-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075498-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL 2001-04-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075498-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL 2001-04-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075498-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2001-04-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075498-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL 2001-04-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075498-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL 2001-04-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075498-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL 2001-04-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075498-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2001-04-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075498-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL 2001-04-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075498-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL 2001-04-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075498-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL 2001-04-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075498-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2001-04-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075498-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL 2001-04-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075498-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL 2001-04-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075498-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL 2001-04-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075498-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2001-04-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075498-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL 2001-04-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075498-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL 2001-04-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075498-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL 2001-04-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075498-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2001-04-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075498-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL 2001-04-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075498-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL 2001-04-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075498-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL 2001-04-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075498-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2001-04-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075498-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL 2001-04-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075498-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL 2001-04-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075498-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL 2001-04-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075498-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL 2001-04-12 d06236e962d9…
Observed Orange Book normalized TE history# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10544-289-30 Terazosin 30 in 1 BOTTLE CAPSULE 30 1 10544-289-90 Terazosin 90 in 1 BOTTLE CAPSULE 90 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TERAZOSIN HYDROCHLORIDE ACTIVE INGREDIENT D32S14F082 TERAZOSIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 TERAZOSIN ACTIVE MOIETY 8L5014XET7 TERAZOSIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 AMMONIA INACTIVE INGREDIENT 5138Q19F1X TERAZOSIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH TERAZOSIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G TERAZOSIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD TERAZOSIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 TERAZOSIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L TERAZOSIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X TERAZOSIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T TERAZOSIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TERAZOSIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O TERAZOSIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TERAZOSIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP TERAZOSIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U TERAZOSIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TERAZOSIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10544-289 TERAZOSIN CAPSULE [BLENHEIM PHARMACAL, INC.] 1 Legacy NDC, 2 package rows 20150218_0f547137-d43a-15f6-e054-00144ff8d46c.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 10544-289-30 10544028930 30 in 1 BOTTLE Historical 10544-289-90 10544028990 90 in 1 BOTTLE Historical