Labetalol Hydrochloride

Product NDC
63629-2450
Requested package NDC
63629-2450-1
11-digit product format
636292450
Labeler code
63629
Product ID
63629-2450_57b18bfe-5ff1-422b-b1b9-49fae7888447
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075215
Marketing category
ANDA
Marketing start
2019-11-22
Marketing end
0000-00-00
Substance
LABETALOL
Active strength
200 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63629-245063629-2450-1DDiscontinued by firm2026-08-03

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 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
A075215-001LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDE100MGTABLET / ORALAB1999-07-29
A075215-002LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDE200MGTABLET / ORALAB1999-07-29
A075215-003LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDE300MGTABLET / ORALAB1999-07-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075215-001AB
A075215-002AB
A075215-003AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075215-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB1999-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075215-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB1999-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075215-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB1999-07-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075215-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB1999-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075215-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB1999-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075215-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB1999-07-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A075215-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB1999-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075215-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB1999-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075215-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB1999-07-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075215-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB1999-07-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075215-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB1999-07-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075215-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB1999-07-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075215-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB1999-07-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075215-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB1999-07-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075215-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB1999-07-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075215-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB1999-07-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075215-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB1999-07-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075215-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB1999-07-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075215-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB1999-07-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075215-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB1999-07-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075215-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB1999-07-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075215-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB1999-07-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075215-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB1999-07-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075215-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB1999-07-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075215-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB1999-07-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075215-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB1999-07-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075215-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB1999-07-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075215-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB1999-07-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A075215-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB1999-07-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A075215-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB1999-07-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075215-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB1999-07-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075215-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB1999-07-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075215-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB1999-07-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075215-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB1999-07-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075215-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB1999-07-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075215-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB1999-07-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075215-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB1999-07-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075215-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB1999-07-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075215-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB1999-07-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075215-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB1999-07-298072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075215-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075215-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075215-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075215-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075215-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075215-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075215-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075215-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075215-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075215-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075215-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075215-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075215-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075215-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075215-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075215-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075215-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075215-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075215-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075215-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075215-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075215-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075215-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075215-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075215-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075215-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075215-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075215-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075215-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075215-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075215-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075215-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075215-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075215-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075215-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075215-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075215-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075215-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075215-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075215-001AB18072bd15b7f6…

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 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepack3909ac9e-6818-4c5d-ad0e-52865a574b452026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075215
application number: ANDA075215
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepack35e7bce0-d9ff-4f8b-95c5-218da2a2d9292026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075215
application number: ANDA075215
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepackf7f7fade-98a6-4741-bfb9-f1eb54ad45652026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075215
application number: ANDA075215
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepack0db22a64-1863-4188-850b-273ea746e3272026-02-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075215
application number: ANDA075215
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepackd8b69cc9-bdee-4e24-a3d8-d1887de5a17d2026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075215
application number: ANDA075215
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepack6f919513-500e-4a05-935e-b6fc1615368a2026-01-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075215
application number: ANDA075215
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEInnogenix, Inc.82fc2d64-0572-4a9b-94fc-f6eb8d930c542025-12-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075215
application number: ANDA075215
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEMethod Pharmaceuticals, LLC733d6e32-ac90-4796-bf25-9d5887c897a52025-12-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075215
application number: ANDA075215
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepack0dcd514d-bda8-484b-8cf1-f5656aaab9ce2025-10-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075215
application number: ANDA075215
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepack20c26652-52da-4eef-8486-f91eb30e9ff72025-10-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075215
application number: ANDA075215
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEREMEDYREPACK INC.e2e50571-d8c1-43e7-b90f-877ba1c35c9b2025-09-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075215
application number: ANDA075215
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEA-S Medication Solutions5faacbcc-f88f-42f7-8702-791ee82c4d182025-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075215
application number: ANDA075215
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepack64cd636d-8b48-4f29-b41d-4a048335793e2024-11-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075215
application number: ANDA075215
Labetalol HydrochlorideLABETALOLMarlex Pharmaceuticals Inc28c91727-e5a8-48b3-a4df-d7bec8feda402024-10-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075215
application number: ANDA075215
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepack94abdd54-a8e2-4858-8183-6c5d04dbceb52024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075215
application number: ANDA075215
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepack1fce27dd-90a6-45cf-9bd7-13147d3cc0d72024-08-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075215
application number: ANDA075215
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepack706a877b-c388-43e7-b083-518111b288b02024-08-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075215
application number: ANDA075215
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepack5a39bb96-4a60-49e8-859c-16bda0fe18e42024-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075215
application number: ANDA075215
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepack143ae21e-c350-4c92-b318-7537f4e465962024-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075215
application number: ANDA075215

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-2450-163629245001500 TABLET, FILM COATED in 1 BOTTLE (63629-2450-1) 2021-02-080000-00-00NoNoCurrent