Home NDC 27241-291 Terazosin
Product NDC 27241-291
11-digit product format 272410291
Labeler code 27241
Product ID 27241-291_ec1b00c3-3d59-420a-a71c-e9bd9a8d02fd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Terazosin
Dosage form CAPSULE
Route ORAL
Labeler Ajanta Pharma USA Inc.
Application ANDA219482
Marketing category ANDA
Marketing start 2025-05-12
Substance TERAZOSIN HYDROCHLORIDE
Active strength 10 mg/1
Pharmacologic classes Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 A219482-001 TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2025-05-12 A219482-002 TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2025-05-12 A219482-003 TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2025-05-12 A219482-004 TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2025-05-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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.
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 A219482-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2025-05-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219482-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2025-05-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219482-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2025-05-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219482-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2025-05-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219482-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2025-05-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219482-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2025-05-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219482-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2025-05-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219482-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2025-05-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219482-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2025-05-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219482-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2025-05-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219482-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2025-05-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219482-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2025-05-12 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219482-001 TERAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2025-05-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219482-002 TERAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE / ORAL AB 2025-05-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219482-003 TERAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE / ORAL AB 2025-05-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219482-004 TERAZOSIN HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 2025-05-12 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Terazosin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TERAZOSIN HYDROCHLORIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination D32S14F082 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 260376 Internal RxNorm lookup 313215 Internal RxNorm lookup 313217 Internal RxNorm lookup 313219 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 27241-291-01 Terazosin 100 in 1 BOTTLE CAPSULE 100 3 27241-291-10 Terazosin 1000 in 1 BOTTLE CAPSULE 1000 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 27241-291 TERAZOSIN CAPSULE [AJANTA PHARMA USA INC.] 2 Current NDC, 2 package rows 20250516_bed99c2a-4266-4a2c-bb0f-7643fdafff78.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 27241-291-01 27241029101 100 CAPSULE in 1 BOTTLE (27241-291-01) 100 capsule 2025-05-12 No No Current 27241-291-10 27241029110 1000 CAPSULE in 1 BOTTLE (27241-291-10) 1000 capsule 2025-05-12 No No Current