Home NDC 0591-0605-00 Labetalol hydrochloride
Product NDC 0591-0605
Requested package NDC 0591-0605-00
11-digit product format 005910605
Labeler code 0591
Product ID 0591-0605_d5dfcb69-d2c4-49ca-a684-83c9e15b3b06
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Labetalol hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA075133
Marketing category ANDA
Marketing start 1998-08-03
Marketing end 2026-09-30
Substance LABETALOL HYDROCHLORIDE
Active strength 100 mg/1
Pharmacologic classes Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag No
Current FDA listing Yes 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 · 21 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 50b4072663b7…eae3003ed65e…2022-04-09 23:13 UTC · source 2022-04-08 906f6e251498…bf70b80e44f0…2021-12-27 23:28 UTC · source 2021-12-27 6db9cb8d1e19…3449e1ec5b70…2021-02-18 23:40 UTC · source 2021-02-18 8fc7167e32ce…e96bbc724034…2020-12-18 03:04 UTC · source 2020-12-17 4184dd79f89f…545327b3e20f…2020-06-10 20:45 UTC · source 2020-06-10 4bd3596a7b87…5c64c6f6865f…2019-12-08 06:16 UTC · source 2019-12-05 263afe128892…91768de4ddbe…2019-06-01 22:24 UTC · source 2019-05-30 5b2001dcd8f5…54b53d4dc9e4…
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 A075133-001 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 A075133-002 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 A075133-003 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03
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 A075133-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075133-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075133-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075133-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075133-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075133-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075133-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075133-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075133-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075133-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075133-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075133-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075133-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075133-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075133-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075133-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075133-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075133-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075133-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075133-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075133-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075133-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075133-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075133-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075133-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075133-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075133-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075133-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075133-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075133-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075133-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075133-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075133-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075133-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075133-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075133-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075133-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075133-002 LABETALOL HYDROCHLORIDE 200MG TABLET / ORAL AB 1998-08-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075133-003 LABETALOL HYDROCHLORIDE 300MG TABLET / ORAL AB 1998-08-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075133-001 LABETALOL HYDROCHLORIDE 100MG TABLET / ORAL AB 1998-08-03 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Labetalol hydrochloride Active Ingredients# Ingredient, Strength table Ingredient Strength LABETALOL HYDROCHLORIDE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1GEV3BAW9J Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 896758 Internal RxNorm lookup 896762 Internal RxNorm lookup 896766 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0591-0605-01 Labetalol hydrochloride 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 16 0591-0605-05 Labetalol hydrochloride 500 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 500 16 0591-0605-10 Labetalol hydrochloride 1000 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 1000 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LABETALOL HYDROCHLORIDE ACTIVE INGREDIENT 1GEV3BAW9J LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 LABETALOL ACTIVE MOIETY R5H8897N95 LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 WATER INACTIVE INGREDIENT 059QF0KO0R LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 LABETALOL HYDROCHLORIDE ACTIVE INGREDIENT 1GEV3BAW9J LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.] 9 LABETALOL ACTIVE MOIETY R5H8897N95 LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.] 9 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.] 9 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.] 9 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.] 9 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.] 9 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.] 9 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.] 9 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.] 9 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.] 9 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.] 9 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.] 9 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.] 9 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.] 9 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.] 9 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.] 9 WATER INACTIVE INGREDIENT 059QF0KO0R LABETALOL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.] 9 LABETALOL HYDROCHLORIDE ACTIVE INGREDIENT 1GEV3BAW9J LABETALOL HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS] 6 LABETALOL ACTIVE MOIETY R5H8897N95 LABETALOL HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS] 6 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK LABETALOL HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS] 6 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LABETALOL HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS] 6 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK LABETALOL HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS] 6 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK LABETALOL HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS] 6 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 LABETALOL HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS] 6 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT LABETALOL HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS] 6 HYPROMELLOSE 2208 (15000 MPA.S) INACTIVE INGREDIENT Z78RG6M2N2 LABETALOL HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LABETALOL HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS] 6 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A LABETALOL HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS] 6 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H LABETALOL HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS] 6 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LABETALOL HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS] 6 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LABETALOL HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS] 6 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LABETALOL HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS] 6 WATER INACTIVE INGREDIENT 059QF0KO0R LABETALOL HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS] 6 LABETALOL HYDROCHLORIDE ACTIVE INGREDIENT 1GEV3BAW9J LABETALOL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 2 LABETALOL ACTIVE MOIETY R5H8897N95 LABETALOL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 2 LABETALOL HYDROCHLORIDE ACTIVE INGREDIENT 1GEV3BAW9J LABETALOL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 LABETALOL ACTIVE MOIETY R5H8897N95 LABETALOL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 LABETALOL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK LABETALOL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LABETALOL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK LABETALOL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK LABETALOL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 LABETALOL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT LABETALOL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LABETALOL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LABETALOL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A LABETALOL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H LABETALOL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LABETALOL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LABETALOL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LABETALOL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R LABETALOL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0591-0605 LABETALOL HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 15 Current NDC, Legacy NDC, 3 package rows 20181129_a5b65a9b-6b8a-48a4-9c72-0e605bb309eb.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Status 0591-0605-00 00591060500 64700 TABLET, FILM COATED in 1 BAG (0591-0605-00) 03-AUG-98 30-SEP-26 Historical