Home NDC 49884-123 Labetalol HCL
Product NDC 49884-123
11-digit product format 498840123
Labeler code 49884
Product ID 49884-123_c2fd5bf2-ce6b-48a7-a782-17dd1df2d326
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Labetalol Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Par Pharmaceutical, Inc.
Application ANDA200908
Marketing category ANDA
Marketing start 2012-07-24
Marketing end 0000-00-00
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 2020-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A200908-001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL 2012-07-10 A200908-002 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL 2012-07-10 A200908-003 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL 2012-07-10
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 · 129 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 2026-09-14 22:38:34 2026-08 A200908-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL 2012-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200908-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL 2012-07-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200908-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL 2012-07-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A200908-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL 2012-07-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200908-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL 2012-07-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200908-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL 2012-07-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200908-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2012-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200908-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 2012-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200908-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2012-07-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200908-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2012-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200908-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 2012-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200908-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2012-07-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200908-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2012-07-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200908-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 2012-07-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200908-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2012-07-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200908-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2012-07-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200908-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 2012-07-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200908-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2012-07-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200908-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2012-07-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200908-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 2012-07-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200908-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2012-07-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200908-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2012-07-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200908-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 2012-07-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200908-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2012-07-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200908-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2012-07-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200908-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 2012-07-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200908-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2012-07-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200908-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2012-07-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200908-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 2012-07-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200908-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2012-07-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200908-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2012-07-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200908-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 2012-07-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200908-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2012-07-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200908-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2012-07-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A200908-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 2012-07-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A200908-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2012-07-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200908-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2012-07-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200908-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB RS 2012-07-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200908-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 2012-07-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200908-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 2012-07-10 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LABETALOL HYDROCHLORIDE ACTIVE INGREDIENT 1GEV3BAW9J LABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.] 9 LABETALOL ACTIVE MOIETY R5H8897N95 LABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.] 9 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.] 9 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK LABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.] 9 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.] 9 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.] 9 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P LABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.] 9 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 LABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.] 9 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.] 9 TALC INACTIVE INGREDIENT 7SEV7J4R1U LABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.] 9 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.] 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49884-123 LABETALOL HCL (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [ENDO USA, INC.] 16 Legacy NDC 20240926_56ab2ff4-14a6-4297-afd8-56b92e1f64a0.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 49884-123-01 49884012301 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49884-123-01) 2012-07-24 0000-00-00 No No Current 49884-123-05 49884012305 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49884-123-05) 2012-07-24 0000-00-00 No No Current