Labetalol Hydrochloride

Product NDC
47781-586
11-digit product format
477810586
Labeler code
47781
Product ID
47781-586_31b2325f-63aa-a3ef-4b01-59e3ab3aba2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Alvogen Inc.
Application
ANDA090699
Marketing category
ANDA
Marketing start
2017-06-01
Marketing end
0000-00-00
Substance
LABETALOL HYDROCHLORIDE
Active strength
5 mg/mL
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct47781-586DDiscontinued by firm2026-08-03
excluded packagepackage47781-58647781-586-29DDiscontinued by firm2026-08-03
excluded packagepackage47781-58647781-586-56DDiscontinued 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 · 26 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage47781-586-29d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage47781-586-56d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage47781-586-29f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage47781-586-56f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage47781-586-292ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage47781-586-562ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage47781-586-29a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage47781-586-56a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage47781-586-29cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage47781-586-56cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage47781-586-29cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage47781-586-56cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage47781-586-29302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage47781-586-56302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage47781-586-29ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage47781-586-56ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage47781-586-290efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage47781-586-560efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage47781-586-29ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage47781-586-56ad56d346431e…cc804d4bbf1e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090699-001LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP2012-04-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090699-001AP

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090699-001LABETALOL HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP2012-04-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090699-001LABETALOL HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP2012-04-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A090699-001LABETALOL HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP2012-04-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090699-001LABETALOL HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP2012-04-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090699-001LABETALOL HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP2012-04-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090699-001LABETALOL HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP2012-04-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090699-001LABETALOL HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP2012-04-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090699-001LABETALOL HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP2012-04-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090699-001LABETALOL HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP2012-04-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090699-001LABETALOL HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP2012-04-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090699-001LABETALOL HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP2012-04-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090699-001LABETALOL HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP2012-04-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090699-001LABETALOL HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP2012-04-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090699-001LABETALOL HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP2012-04-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090699-001LABETALOL HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP2012-04-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090699-001LABETALOL HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP2012-04-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090699-001LABETALOL HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP2012-04-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090699-001LABETALOL HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP2012-04-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090699-001LABETALOL HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP2012-04-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090699-001LABETALOL HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP2012-04-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090699-001LABETALOL HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP2012-04-0387673890dc5c…
2021-03-12 10:30 UTC2021-03A090699-001LABETALOL HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP2012-04-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090699-001LABETALOL HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP2012-04-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090699-001LABETALOL HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP2012-04-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090699-001LABETALOL HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP2012-04-033f01610625f2…
2019-09-15 20:21 UTC2019-09A090699-001LABETALOL HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP2012-04-03b00525d2431f…
2019-07-19 19:46 UTC2019-07A090699-001LABETALOL HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP2012-04-03ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090699-001LABETALOL HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP2012-04-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090699-001LABETALOL HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP2012-04-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090699-001LABETALOL HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP2012-04-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090699-001LABETALOL HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP2012-04-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090699-001LABETALOL HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP2012-04-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090699-001LABETALOL HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP2012-04-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090699-001LABETALOL HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP2012-04-033f0d92c62455…
2023-05-13 08:27 UTC2023-05A090699-001LABETALOL HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP2012-04-03053a50430f4f…
2023-01-26 05:58 UTC2023-01A090699-001LABETALOL HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP2012-04-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090699-001LABETALOL HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP2012-04-033a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090699-001LABETALOL HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP2012-04-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090699-001LABETALOL HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP2012-04-03e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090699-001LABETALOL HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP2012-04-03cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090699-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090699-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090699-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090699-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090699-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090699-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090699-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090699-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090699-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090699-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090699-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090699-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090699-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090699-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090699-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090699-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090699-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090699-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090699-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090699-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090699-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A090699-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090699-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090699-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090699-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A090699-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090699-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090699-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090699-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090699-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090699-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090699-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090699-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090699-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090699-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090699-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090699-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090699-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090699-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090699-001AP1cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-586-29ML - Milliliter47781-586829b60e6-ab01-41d8-8cdb-53507e6288e412017-07-07
47781-586-56ML - Milliliter47781-586835dd71d-f238-43a8-9984-ba07ce5efe6812017-07-07

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEMullan Pharmaceutical Inc.fb5ef3ba-0a7e-4f41-9547-d734983da0d32025-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090699
application number: ANDA090699
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEGland Pharma Limited48caf986-3126-48e1-afcd-16d65c9cfe002024-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090699
application number: ANDA090699
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEFosun Pharma USA Inc.4a5ffab2-a3b8-411e-992d-7f38d508643a2024-05-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090699
application number: ANDA090699
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEFosun Pharma USA Inc.f18dff28-f6f5-4ecb-9797-25062e2475592021-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090699
application number: ANDA090699

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47781-586-29477810586291 VIAL, MULTI-DOSE in 1 CARTON (47781-586-29) > 20 mL in 1 VIAL, MULTI-DOSE2017-06-010000-00-00NoNoCurrent
47781-586-56477810586561 VIAL, MULTI-DOSE in 1 CARTON (47781-586-56) > 40 mL in 1 VIAL, MULTI-DOSE2017-06-010000-00-00NoNoCurrent