Home NDC 0378-6993 Levalbuterol
Product NDC 0378-6993
11-digit product format 003786993
Labeler code 0378
Product ID 0378-6993_0aa39730-fc51-4088-8955-b11aac3025d0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name levalbuterol
Dosage form SOLUTION, CONCENTRATE
Route RESPIRATORY (INHALATION)
Labeler Mylan Pharmaceuticals Inc.
Application ANDA078309
Marketing category ANDA
Marketing start 2009-08-28
Substance LEVALBUTEROL HYDROCHLORIDE
Active strength 1.25 mg/.5mL
Pharmacologic classes Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 A078309-001 LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION / INHALATION AN RS 2009-03-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078309-001 AN
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 A078309-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION / INHALATION AN RS 2009-03-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078309-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION / INHALATION AN RS 2009-03-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078309-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION / INHALATION AN RS 2009-03-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078309-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION / INHALATION AN RS 2009-03-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078309-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION / INHALATION AN RS 2009-03-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078309-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION / INHALATION AN RS 2009-03-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078309-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION / INHALATION AN RS 2009-03-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078309-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION / INHALATION AN RS 2009-03-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078309-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION / INHALATION AN RS 2009-03-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078309-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION / INHALATION AN RS 2009-03-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078309-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION / INHALATION AN RS 2009-03-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078309-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION / INHALATION AN RS 2009-03-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078309-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION / INHALATION AN RS 2009-03-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078309-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION / INHALATION AN RS 2009-03-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078309-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION / INHALATION AN 2009-03-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078309-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION / INHALATION AN 2009-03-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078309-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION / INHALATION AN 2009-03-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078309-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION / INHALATION AN 2009-03-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078309-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION / INHALATION AN 2009-03-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078309-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION / INHALATION AN 2009-03-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078309-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION / INHALATION AN 2009-03-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078309-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION / INHALATION AN 2009-03-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078309-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION / INHALATION AN 2009-03-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078309-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION / INHALATION AN 2009-03-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078309-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION / INHALATION AN 2009-03-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078309-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION / INHALATION AN 2009-03-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078309-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION / INHALATION AN 2009-03-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078309-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION / INHALATION AN 2009-03-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078309-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION / INHALATION AN 2009-03-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078309-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION / INHALATION AN 2009-03-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078309-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION / INHALATION AN 2009-03-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078309-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION / INHALATION AN 2009-03-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078309-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION / INHALATION AN 2009-03-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078309-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION / INHALATION AN 2009-03-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078309-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION / INHALATION AN 2009-03-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078309-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION / INHALATION AN 2009-03-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078309-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION / INHALATION AN 2009-03-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078309-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION / INHALATION AN 2009-03-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078309-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION / INHALATION AN 2009-03-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078309-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION / INHALATION AN 2009-03-20 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Levalbuterol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEVALBUTEROL HYDROCHLORIDE 1.25 mg/.5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WDQ1526QJM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1855389 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 0378-6993-31 Levalbuterol 1 in 1 POUCH SOLUTION, CONCENTRATE 1 15 0378-6993-31 Levalbuterol .5 mL in 1 VIAL SOLUTION, CONCENTRATE .5 15 0378-6993-93 Levalbuterol 30 in 1 CARTON SOLUTION, CONCENTRATE 30 15
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-6993 LEVALBUTEROL SOLUTION, CONCENTRATE [MYLAN PHARMACEUTICALS INC.] 15 Current NDC, Legacy NDC, 3 package rows 20191123_206bbdec-04f0-40e3-a259-32fc6bce20d8.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 Units Marketing start Marketing end Sample Exclude flag Status 0378-6993-31 00378699331 1 in 1 POUCH Historical 0378-6993-93 00378699393 30 POUCH in 1 CARTON (0378-6993-93) / 1 VIAL in 1 POUCH (0378-6993-31) / .5 mL in 1 VIAL 30 pouch 2009-08-28 0000-00-00 No No Current