Home NDC 0023-4385 BETAGAN
Product NDC 0023-4385
11-digit product format 000234385
Labeler code 0023
Product ID 0023-4385_21d89a13-52ed-4d3b-82ff-9ef2d8f34900
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name levobunolol hydrochloride
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Allergan, Inc.
Application NDA019219
Marketing category NDA
Marketing start 1986-07-24
Marketing end 0000-00-00
Substance LEVOBUNOLOL 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 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 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019219-002 BETAGAN LEVOBUNOLOL HYDROCHLORIDE 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-12-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N019219-002 AT
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N019219-002 BETAGAN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-12-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019219-002 BETAGAN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-12-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019219-002 BETAGAN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-12-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019219-002 BETAGAN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-12-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019219-002 BETAGAN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-12-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019219-002 BETAGAN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-12-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019219-002 BETAGAN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-12-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019219-002 BETAGAN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-12-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019219-002 BETAGAN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-12-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019219-002 BETAGAN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-12-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019219-002 BETAGAN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-12-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019219-002 BETAGAN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-12-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019219-002 BETAGAN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-12-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019219-002 BETAGAN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-12-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019219-002 BETAGAN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-12-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019219-002 BETAGAN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-12-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019219-002 BETAGAN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-12-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019219-002 BETAGAN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-12-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019219-002 BETAGAN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-12-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019219-002 BETAGAN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-12-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019219-002 BETAGAN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-12-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019219-002 BETAGAN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-12-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019219-002 BETAGAN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-12-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019219-002 BETAGAN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-12-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019219-002 BETAGAN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-12-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019219-002 BETAGAN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-12-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019219-002 BETAGAN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-12-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019219-002 BETAGAN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-12-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019219-002 BETAGAN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-12-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019219-002 BETAGAN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-12-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019219-002 BETAGAN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-12-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019219-002 BETAGAN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-12-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019219-002 BETAGAN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-12-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019219-002 BETAGAN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-12-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019219-002 BETAGAN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-12-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019219-002 BETAGAN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-12-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019219-002 BETAGAN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-12-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019219-002 BETAGAN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-12-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019219-002 BETAGAN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-12-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N019219-002 BETAGAN 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1985-12-19 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded levobunolol hydrochloride ACTIVE INGREDIENT O90S49LDHH BETAGAN (LEVOBUNOLOL HYDROCHLORIDE) SOLUTION/ DROPS [ALLERGAN, INC.] 12 levobunolol ACTIVE MOIETY G6317AOI7K BETAGAN (LEVOBUNOLOL HYDROCHLORIDE) SOLUTION/ DROPS [ALLERGAN, INC.] 12 benzalkonium chloride INACTIVE INGREDIENT F5UM2KM3W7 BETAGAN (LEVOBUNOLOL HYDROCHLORIDE) SOLUTION/ DROPS [ALLERGAN, INC.] 12 edetate disodium INACTIVE INGREDIENT 7FLD91C86K BETAGAN (LEVOBUNOLOL HYDROCHLORIDE) SOLUTION/ DROPS [ALLERGAN, INC.] 12 hydrochloric acid INACTIVE INGREDIENT QTT17582CB BETAGAN (LEVOBUNOLOL HYDROCHLORIDE) SOLUTION/ DROPS [ALLERGAN, INC.] 12 polyvinyl alcohol INACTIVE INGREDIENT 532B59J990 BETAGAN (LEVOBUNOLOL HYDROCHLORIDE) SOLUTION/ DROPS [ALLERGAN, INC.] 12 potassium phosphate, monobasic INACTIVE INGREDIENT 4J9FJ0HL51 BETAGAN (LEVOBUNOLOL HYDROCHLORIDE) SOLUTION/ DROPS [ALLERGAN, INC.] 12 sodium chloride INACTIVE INGREDIENT 451W47IQ8X BETAGAN (LEVOBUNOLOL HYDROCHLORIDE) SOLUTION/ DROPS [ALLERGAN, INC.] 12 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I BETAGAN (LEVOBUNOLOL HYDROCHLORIDE) SOLUTION/ DROPS [ALLERGAN, INC.] 12 sodium metabisulfite INACTIVE INGREDIENT 4VON5FNS3C BETAGAN (LEVOBUNOLOL HYDROCHLORIDE) SOLUTION/ DROPS [ALLERGAN, INC.] 12 sodium phosphate, dibasic INACTIVE INGREDIENT GR686LBA74 BETAGAN (LEVOBUNOLOL HYDROCHLORIDE) SOLUTION/ DROPS [ALLERGAN, INC.] 12 water INACTIVE INGREDIENT 059QF0KO0R BETAGAN (LEVOBUNOLOL HYDROCHLORIDE) SOLUTION/ DROPS [ALLERGAN, INC.] 12