Midodrine Hydrochloride

Product NDC
70700-159
11-digit product format
707000159
Labeler code
70700
Product ID
70700-159_2214523a-41b1-3644-6e7c-abc4f8b0b5cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
midodrine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Xiromed, LLC
Application
ANDA207849
Marketing category
ANDA
Marketing start
2020-10-15
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 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207849-001MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDE2.5MGTABLET / ORALAB2020-10-01
A207849-002MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDE5MGTABLET / ORALAB2020-10-01
A207849-003MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDE10MGTABLET / ORALAB2020-10-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A207849-001AB
A207849-002AB
A207849-003AB

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 3 · 111 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207849-001MIDODRINE HYDROCHLORIDE2.5MGTABLET / ORALAB2020-10-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207849-002MIDODRINE HYDROCHLORIDE5MGTABLET / ORALAB2020-10-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207849-003MIDODRINE HYDROCHLORIDE10MGTABLET / ORALAB2020-10-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207849-001MIDODRINE HYDROCHLORIDE2.5MGTABLET / ORALAB2020-10-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207849-002MIDODRINE HYDROCHLORIDE5MGTABLET / ORALAB2020-10-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207849-003MIDODRINE HYDROCHLORIDE10MGTABLET / ORALAB2020-10-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207849-001MIDODRINE HYDROCHLORIDE2.5MGTABLET / ORALAB2020-10-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207849-002MIDODRINE HYDROCHLORIDE5MGTABLET / ORALAB2020-10-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207849-003MIDODRINE HYDROCHLORIDE10MGTABLET / ORALAB2020-10-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207849-001MIDODRINE HYDROCHLORIDE2.5MGTABLET / ORALAB2020-10-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207849-002MIDODRINE HYDROCHLORIDE5MGTABLET / ORALAB2020-10-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207849-003MIDODRINE HYDROCHLORIDE10MGTABLET / ORALAB2020-10-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207849-001MIDODRINE HYDROCHLORIDE2.5MGTABLET / ORALAB2020-10-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207849-002MIDODRINE HYDROCHLORIDE5MGTABLET / ORALAB2020-10-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207849-003MIDODRINE HYDROCHLORIDE10MGTABLET / ORALAB2020-10-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207849-001MIDODRINE HYDROCHLORIDE2.5MGTABLET / ORALAB2020-10-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207849-002MIDODRINE HYDROCHLORIDE5MGTABLET / ORALAB2020-10-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207849-003MIDODRINE HYDROCHLORIDE10MGTABLET / ORALAB2020-10-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207849-001MIDODRINE HYDROCHLORIDE2.5MGTABLET / ORALAB2020-10-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207849-002MIDODRINE HYDROCHLORIDE5MGTABLET / ORALAB2020-10-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207849-003MIDODRINE HYDROCHLORIDE10MGTABLET / ORALAB2020-10-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207849-001MIDODRINE HYDROCHLORIDE2.5MGTABLET / ORALAB2020-10-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207849-002MIDODRINE HYDROCHLORIDE5MGTABLET / ORALAB2020-10-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207849-003MIDODRINE HYDROCHLORIDE10MGTABLET / ORALAB2020-10-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207849-001MIDODRINE HYDROCHLORIDE2.5MGTABLET / ORALAB2020-10-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207849-002MIDODRINE HYDROCHLORIDE5MGTABLET / ORALAB2020-10-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207849-003MIDODRINE HYDROCHLORIDE10MGTABLET / ORALAB2020-10-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207849-001MIDODRINE HYDROCHLORIDE2.5MGTABLET / ORALAB2020-10-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A207849-002MIDODRINE HYDROCHLORIDE5MGTABLET / ORALAB2020-10-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A207849-003MIDODRINE HYDROCHLORIDE10MGTABLET / ORALAB2020-10-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207849-001MIDODRINE HYDROCHLORIDE2.5MGTABLET / ORALAB2020-10-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207849-002MIDODRINE HYDROCHLORIDE5MGTABLET / ORALAB2020-10-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207849-003MIDODRINE HYDROCHLORIDE10MGTABLET / ORALAB2020-10-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207849-001MIDODRINE HYDROCHLORIDE2.5MGTABLET / ORALAB2020-10-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207849-002MIDODRINE HYDROCHLORIDE5MGTABLET / ORALAB2020-10-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207849-003MIDODRINE HYDROCHLORIDE10MGTABLET / ORALAB2020-10-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207849-001MIDODRINE HYDROCHLORIDE2.5MGTABLET / ORALAB2020-10-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207849-002MIDODRINE HYDROCHLORIDE5MGTABLET / ORALAB2020-10-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207849-003MIDODRINE HYDROCHLORIDE10MGTABLET / ORALAB2020-10-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207849-001MIDODRINE HYDROCHLORIDE2.5MGTABLET / ORALAB2020-10-018072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207849-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207849-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207849-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207849-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207849-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207849-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207849-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207849-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207849-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207849-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207849-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207849-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207849-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207849-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207849-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207849-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207849-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207849-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207849-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207849-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207849-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207849-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207849-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207849-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207849-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207849-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207849-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207849-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207849-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207849-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207849-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207849-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207849-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207849-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207849-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207849-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207849-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207849-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207849-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207849-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Midodrine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MIDODRINE HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
59JV96YTXVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
993462Internal RxNorm lookup
993466Internal RxNorm lookup
993470Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a4332a41-2a0a-a14a-9ce5-1465f39ff725Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ee08dc62-0af6-bb42-639c-6cdc4aad4b08Product name620250801

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70700-159-01Midodrine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET1007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70700-159MIDODRINE HYDROCHLORIDE TABLET [XIROMED, LLC]7Current NDC, Legacy NDC, 1 package rows20221117_a4332a41-2a0a-a14a-9ce5-1465f39ff725.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Midodrine HydrochlorideMIDODRINE HYDROCHLORIDEBryant Ranch Prepack78446de1-81f6-4764-98f3-44b4057f21752024-02-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207849
application number: ANDA207849
Midodrine HydrochlorideMIDODRINE HYDROCHLORIDEBryant Ranch Prepack572edc14-3450-46db-bec6-9d63e620a3642024-02-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207849
application number: ANDA207849
Midodrine HydrochlorideMIDODRINE HYDROCHLORIDEBryant Ranch Prepack9c1ccd24-3f9c-489c-9fd2-98e69531d5ab2024-02-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207849
application number: ANDA207849
Midodrine HydrochlorideMIDODRINE HYDROCHLORIDEBryant Ranch Prepack6498f9ab-3345-4343-918e-9c5014d6dd802024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207849
application number: ANDA207849
Midodrine HydrochlorideMIDODRINE HYDROCHLORIDEBryant Ranch Prepackdf43f108-c89c-49e7-9c1a-77a0ce9b03b52024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207849
application number: ANDA207849
Midodrine HydrochlorideMIDODRINE HYDROCHLORIDEBryant Ranch Prepack7ec8fb86-18c4-4751-87e4-ca1e9e8850882024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207849
application number: ANDA207849
Midodrine HydrochlorideMIDODRINE HYDROCHLORIDEGolden State Medical Supply, Inc.c4d0b757-bb6e-4df4-e053-2995a90a30422023-10-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207849
application number: ANDA207849
Midodrine HydrochlorideMIDODRINE HYDROCHLORIDEProficient Rx LP0aebf5f9-8cfa-4b77-ba40-821ce0a2b2662022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207849
application number: ANDA207849
Midodrine HydrochlorideMIDODRINE HYDROCHLORIDEXiromed, LLCa4332a41-2a0a-a14a-9ce5-1465f39ff7252020-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207849
application number: ANDA207849
ndc (product): 70700-159

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993462midodrine HCl 10 MG Oral TabletPSNdf43f108-c89c-49e7-9c1a-77a0ce9b03b5103
993462midodrine hydrochloride 10 MG Oral TabletSCDdf43f108-c89c-49e7-9c1a-77a0ce9b03b5103
993462midodrine HCl 10 MG Oral TabletPSN78446de1-81f6-4764-98f3-44b4057f2175100
993462midodrine hydrochloride 10 MG Oral TabletSCD78446de1-81f6-4764-98f3-44b4057f2175100
993462midodrine HCl 10 MG Oral TabletPSNa4332a41-2a0a-a14a-9ce5-1465f39ff7257
993466midodrine HCl 2.5 MG Oral TabletPSNa4332a41-2a0a-a14a-9ce5-1465f39ff7257
993470midodrine HCl 5 MG Oral TabletPSNa4332a41-2a0a-a14a-9ce5-1465f39ff7257
993462midodrine hydrochloride 10 MG Oral TabletSCDa4332a41-2a0a-a14a-9ce5-1465f39ff7257
993466midodrine hydrochloride 2.5 MG Oral TabletSCDa4332a41-2a0a-a14a-9ce5-1465f39ff7257
993470midodrine hydrochloride 5 MG Oral TabletSCDa4332a41-2a0a-a14a-9ce5-1465f39ff7257
993462midodrine HCl 10 MG Oral TabletPSNc4d0b757-bb6e-4df4-e053-2995a90a30423
993466midodrine HCl 2.5 MG Oral TabletPSNc4d0b757-bb6e-4df4-e053-2995a90a30423
993470midodrine HCl 5 MG Oral TabletPSNc4d0b757-bb6e-4df4-e053-2995a90a30423
993462midodrine hydrochloride 10 MG Oral TabletSCDc4d0b757-bb6e-4df4-e053-2995a90a30423
993466midodrine hydrochloride 2.5 MG Oral TabletSCDc4d0b757-bb6e-4df4-e053-2995a90a30423
993470midodrine hydrochloride 5 MG Oral TabletSCDc4d0b757-bb6e-4df4-e053-2995a90a30423
993462midodrine HCl 10 MG Oral TabletPSN0aebf5f9-8cfa-4b77-ba40-821ce0a2b2662
993466midodrine HCl 2.5 MG Oral TabletPSN0aebf5f9-8cfa-4b77-ba40-821ce0a2b2662
993470midodrine HCl 5 MG Oral TabletPSN0aebf5f9-8cfa-4b77-ba40-821ce0a2b2662
993462midodrine hydrochloride 10 MG Oral TabletSCD0aebf5f9-8cfa-4b77-ba40-821ce0a2b2662
993466midodrine hydrochloride 2.5 MG Oral TabletSCD0aebf5f9-8cfa-4b77-ba40-821ce0a2b2662
993470midodrine hydrochloride 5 MG Oral TabletSCD0aebf5f9-8cfa-4b77-ba40-821ce0a2b2662

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70700-159-0170700015901100 TABLET in 1 BOTTLE, PLASTIC (70700-159-01) 100 tablet2020-10-150000-00-00NoNoCurrent