Home NDC 0245-0213 Midodrine Hydrochloride
Product NDC 0245-0213
11-digit product format 002450213
Labeler code 0245
Product ID 0245-0213_18b0b9f5-6026-479e-af12-92b0e71a9d6b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name midodrine hydrochloride
Dosage form TABLET
Route ORAL
Labeler Upsher-Smith laboratories, LLC
Application ANDA076725
Marketing category ANDA
Marketing start 2004-11-03
Substance MIDODRINE HYDROCHLORIDE
Active strength 10 mg/1
Pharmacologic classes Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076725-001 ORVATEN MIDODRINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2004-11-03 A076725-002 ORVATEN MIDODRINE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 2004-11-03 A076725-003 ORVATEN MIDODRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2004-11-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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.
Product history page 1 of 4 · 126 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 2026-08-18 06:07:40 2026-07 A076725-001 ORVATEN 2.5MG TABLET / ORAL AB 2004-11-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076725-002 ORVATEN 5MG TABLET / ORAL AB RS 2004-11-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076725-003 ORVATEN 10MG TABLET / ORAL AB 2004-11-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076725-001 ORVATEN 2.5MG TABLET / ORAL AB 2004-11-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076725-002 ORVATEN 5MG TABLET / ORAL AB RS 2004-11-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076725-003 ORVATEN 10MG TABLET / ORAL AB 2004-11-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076725-001 ORVATEN 2.5MG TABLET / ORAL AB 2004-11-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076725-002 ORVATEN 5MG TABLET / ORAL AB RS 2004-11-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076725-003 ORVATEN 10MG TABLET / ORAL AB 2004-11-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076725-001 ORVATEN 2.5MG TABLET / ORAL AB 2004-11-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076725-002 ORVATEN 5MG TABLET / ORAL AB RS 2004-11-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076725-003 ORVATEN 10MG TABLET / ORAL AB 2004-11-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076725-001 ORVATEN 2.5MG TABLET / ORAL AB 2004-11-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076725-002 ORVATEN 5MG TABLET / ORAL AB RS 2004-11-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076725-003 ORVATEN 10MG TABLET / ORAL AB 2004-11-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076725-001 ORVATEN 2.5MG TABLET / ORAL AB 2004-11-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076725-002 ORVATEN 5MG TABLET / ORAL AB RS 2004-11-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076725-003 ORVATEN 10MG TABLET / ORAL AB 2004-11-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076725-001 ORVATEN 2.5MG TABLET / ORAL AB 2004-11-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076725-002 ORVATEN 5MG TABLET / ORAL AB RS 2004-11-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076725-003 ORVATEN 10MG TABLET / ORAL AB 2004-11-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076725-001 ORVATEN 2.5MG TABLET / ORAL AB 2004-11-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076725-002 ORVATEN 5MG TABLET / ORAL AB RS 2004-11-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076725-003 ORVATEN 10MG TABLET / ORAL AB 2004-11-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076725-001 ORVATEN 2.5MG TABLET / ORAL AB 2004-11-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076725-002 ORVATEN 5MG TABLET / ORAL AB RS 2004-11-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076725-003 ORVATEN 10MG TABLET / ORAL AB 2004-11-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076725-001 ORVATEN 2.5MG TABLET / ORAL AB 2004-11-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076725-002 ORVATEN 5MG TABLET / ORAL AB RS 2004-11-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076725-003 ORVATEN 10MG TABLET / ORAL AB 2004-11-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076725-001 ORVATEN 2.5MG TABLET / ORAL AB 2004-11-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076725-002 ORVATEN 5MG TABLET / ORAL AB RS 2004-11-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076725-003 ORVATEN 10MG TABLET / ORAL AB 2004-11-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076725-001 ORVATEN 2.5MG TABLET / ORAL AB 2004-11-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076725-002 ORVATEN 5MG TABLET / ORAL AB RS 2004-11-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076725-003 ORVATEN 10MG TABLET / ORAL AB 2004-11-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076725-001 ORVATEN 2.5MG TABLET / ORAL AB 2004-11-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076725-002 ORVATEN 5MG TABLET / ORAL AB RS 2004-11-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076725-003 ORVATEN 10MG TABLET / ORAL AB 2004-11-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076725-001 ORVATEN 2.5MG TABLET / ORAL AB 2004-11-03 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Midodrine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MIDODRINE 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 59JV96YTXV Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 993462 Internal RxNorm lookup 993466 Internal RxNorm lookup 993470 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 0245-0213-01 Midodrine Hydrochloride 100 in 1 CARTON TABLET 100 12 0245-0213-11 Midodrine Hydrochloride 100 in 1 BOTTLE TABLET 100 12 0245-0213-89 Midodrine Hydrochloride 1 in 1 BLISTER PACK TABLET 1 12
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0245-0213 MIDODRINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, LLC] 11 Current NDC, Legacy NDC, 3 package rows 20240606_4c3517f3-1c68-4ade-b5f1-c488a3a335c1.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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Midodrine Hydrochloride MIDODRINE HYDROCHLORIDE Avet Pharmaceuticals Inc. 4d5e42be-3476-85d4-e063-6294a90a0865 2026-03-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076725 application number: ANDA076725 Midodrine Hydrochloride MIDODRINE HYDROCHLORIDE Cardinal Health 107, LLC 24847065-0be0-46eb-a084-7e5425a8be73 2025-10-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076725 application number: ANDA076725 Midodrine Hydrochloride MIDODRINE HYDROCHLORIDE Upsher-Smith laboratories, LLC 4c3517f3-1c68-4ade-b5f1-c488a3a335c1 2025-07-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076725 application number: ANDA076725 ndc (product): 0245-0213
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0245-0213-01 00245021301 100 BLISTER PACK in 1 CARTON (0245-0213-01) / 1 TABLET in 1 BLISTER PACK (0245-0213-89) 100 blister pack 2004-11-03 0000-00-00 No No Current 0245-0213-11 00245021311 100 TABLET in 1 BOTTLE (0245-0213-11) 100 tablet 2004-11-03 0000-00-00 No No Current 0245-0213-89 00245021389 1 in 1 BLISTER PACK Historical