FDA.reportPublic FDA data

Labetalol Hydrochloride

Product NDC
14803-504
11-digit product format
148030504
Labeler code
14803
Product ID
14803-504_86c041ec-0940-2e5b-e053-2a91aa0a2b4c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ELYSIUM PHARMACEUTICALS LIMITED
Application
ANDA207863
Marketing category
ANDA
Marketing start
2017-04-27
Marketing end
0000-00-00
Substance
LABETALOL HYDROCHLORIDE
Active strength
300 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A207863-001LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDE100MGTABLET / ORALAB2019-02-04
A207863-002LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDE200MGTABLET / ORALAB2019-02-04
A207863-003LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDE300MGTABLET / ORALAB2019-02-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207863-001AB
A207863-002AB
A207863-003AB

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 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A207863-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB2019-02-04c2088c7a36db…
2026-10-15 13:18:302026-09A207863-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB2019-02-04c2088c7a36db…
2026-10-15 13:18:302026-09A207863-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB2019-02-04c2088c7a36db…
2026-09-14 22:38:342026-08A207863-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB2019-02-0484e616aacf4f…
2026-09-14 22:38:342026-08A207863-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB2019-02-0484e616aacf4f…
2026-09-14 22:38:342026-08A207863-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB2019-02-0484e616aacf4f…
2026-08-18 06:07:402026-07A207863-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB2019-02-04caaa826d4ba7…
2026-08-18 06:07:402026-07A207863-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB2019-02-04caaa826d4ba7…
2026-08-18 06:07:402026-07A207863-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB2019-02-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207863-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB2019-02-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207863-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB2019-02-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207863-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB2019-02-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207863-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB2019-02-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207863-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB2019-02-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207863-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB2019-02-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A207863-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB2019-02-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207863-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB2019-02-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207863-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB2019-02-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207863-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB2019-02-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207863-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB2019-02-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207863-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB2019-02-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207863-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB2019-02-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207863-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB2019-02-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207863-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB2019-02-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207863-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB2019-02-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207863-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB2019-02-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207863-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB2019-02-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207863-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB2019-02-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207863-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB2019-02-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207863-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB2019-02-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207863-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB2019-02-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207863-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB2019-02-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207863-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB2019-02-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207863-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB2019-02-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207863-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB2019-02-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207863-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB2019-02-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207863-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB2019-02-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A207863-002LABETALOL HYDROCHLORIDE200MGTABLET / ORALAB2019-02-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A207863-003LABETALOL HYDROCHLORIDE300MGTABLET / ORALAB2019-02-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207863-001LABETALOL HYDROCHLORIDE100MGTABLET / ORALAB2019-02-0479d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2020-11-12 02:37 UTC2020-11A207863-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207863-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A207863-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A207863-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A207863-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A207863-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A207863-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A207863-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A207863-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A207863-003AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207863-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207863-002AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207863-003AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207863-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A207863-002AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A207863-003AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207863-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A207863-002AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A207863-003AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207863-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207863-002AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207863-003AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207863-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207863-002AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207863-003AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207863-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207863-002AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207863-003AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207863-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207863-002AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207863-003AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A207863-001AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A207863-002AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A207863-003AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A207863-001AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A207863-002AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A207863-003AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207863-001AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207863-002AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207863-003AB13a93d1ddd44b…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.