Home NDC 68001-204 Labetalol HCl
Product NDC 68001-204
11-digit product format 680010204
Labeler code 68001
Product ID 68001-204_9906473a-c9c4-46bf-e053-2995a90abc7e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Labetalol HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler BluePoint Laboratories
Application ANDA075113
Marketing category ANDA
Marketing start 2014-02-26
Marketing end 2021-03-31
Substance LABETALOL HYDROCHLORIDE
Active strength 200 mg/1
Pharmacologic classes Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record 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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A075113-001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-04 A075113-002 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 1998-08-04 A075113-003 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-04
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 A075113-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075113-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 1998-08-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075113-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075113-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075113-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 1998-08-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075113-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075113-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075113-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 1998-08-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075113-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075113-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075113-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 1998-08-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075113-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075113-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075113-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 1998-08-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075113-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075113-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075113-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 1998-08-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075113-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075113-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075113-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 1998-08-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075113-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075113-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075113-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 1998-08-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075113-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075113-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075113-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 1998-08-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075113-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075113-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075113-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 1998-08-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075113-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075113-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075113-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 1998-08-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075113-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075113-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075113-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 1998-08-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075113-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075113-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075113-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 1998-08-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075113-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075113-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-04 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LABETALOL HYDROCHLORIDE ACTIVE INGREDIENT 1GEV3BAW9J LABETALOL HCL TABLET, FILM COATED [BLUEPOINT LABORATORIES] 3 LABETALOL ACTIVE MOIETY R5H8897N95 LABETALOL HCL TABLET, FILM COATED [BLUEPOINT LABORATORIES] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LABETALOL HCL TABLET, FILM COATED [BLUEPOINT LABORATORIES] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LABETALOL HCL TABLET, FILM COATED [BLUEPOINT LABORATORIES] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LABETALOL HCL TABLET, FILM COATED [BLUEPOINT LABORATORIES] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A LABETALOL HCL TABLET, FILM COATED [BLUEPOINT LABORATORIES] 3 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H LABETALOL HCL TABLET, FILM COATED [BLUEPOINT LABORATORIES] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 LABETALOL HCL TABLET, FILM COATED [BLUEPOINT LABORATORIES] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LABETALOL HCL TABLET, FILM COATED [BLUEPOINT LABORATORIES] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LABETALOL HCL TABLET, FILM COATED [BLUEPOINT LABORATORIES] 3 LABETALOL HYDROCHLORIDE ACTIVE INGREDIENT 1GEV3BAW9J LABETALOL HCL TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 LABETALOL ACTIVE MOIETY R5H8897N95 LABETALOL HCL TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LABETALOL HCL TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LABETALOL HCL TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LABETALOL HCL TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A LABETALOL HCL TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H LABETALOL HCL TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 LABETALOL HCL TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LABETALOL HCL TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LABETALOL HCL TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68001-204-00 68001020400 100 TABLET, FILM COATED in 1 BOTTLE (68001-204-00) 2014-02-26 2021-03-31 No No Current 68001-204-03 68001020403 500 TABLET, FILM COATED in 1 BOTTLE (68001-204-03) 2014-02-26 2021-03-31 No No Current