Home NDC 81894-103 Levalbuterol
Product NDC 81894-103
11-digit product format 818940103
Labeler code 81894
Product ID 81894-103_29ead193-b33d-7f78-e063-6294a90a7ef4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levalbuterol
Dosage form SOLUTION
Route RESPIRATORY (INHALATION)
Labeler Luoxin Aurovitas Pharma (Chengdu) Co., Ltd.
Application ANDA207625
Marketing category ANDA
Marketing start 2016-12-30
Substance LEVALBUTEROL HYDROCHLORIDE
Active strength 1.25 mg/3mL
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 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 A207625-001 LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION / INHALATION AN 2016-12-30 A207625-002 LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION / INHALATION AN 2016-12-30 A207625-003 LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION / INHALATION AN 2016-12-30
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 · 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 A207625-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION / INHALATION AN 2016-12-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207625-002 LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION / INHALATION AN 2016-12-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207625-003 LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION / INHALATION AN 2016-12-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A207625-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION / INHALATION AN 2016-12-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207625-002 LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION / INHALATION AN 2016-12-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207625-003 LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION / INHALATION AN 2016-12-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207625-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION / INHALATION AN 2016-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207625-002 LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION / INHALATION AN 2016-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207625-003 LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION / INHALATION AN 2016-12-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207625-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION / INHALATION AN 2016-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207625-002 LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION / INHALATION AN 2016-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207625-003 LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION / INHALATION AN 2016-12-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207625-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION / INHALATION AN 2016-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207625-002 LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION / INHALATION AN 2016-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207625-003 LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION / INHALATION AN 2016-12-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207625-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION / INHALATION AN 2016-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207625-002 LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION / INHALATION AN 2016-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207625-003 LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION / INHALATION AN 2016-12-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207625-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION / INHALATION AN 2016-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207625-002 LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION / INHALATION AN 2016-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207625-003 LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION / INHALATION AN 2016-12-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207625-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION / INHALATION AN 2016-12-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207625-002 LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION / INHALATION AN 2016-12-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207625-003 LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION / INHALATION AN 2016-12-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207625-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION / INHALATION AN 2016-12-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207625-002 LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION / INHALATION AN 2016-12-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207625-003 LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION / INHALATION AN 2016-12-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207625-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION / INHALATION AN 2016-12-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207625-002 LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION / INHALATION AN 2016-12-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207625-003 LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION / INHALATION AN 2016-12-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207625-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION / INHALATION AN 2016-12-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207625-002 LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION / INHALATION AN 2016-12-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207625-003 LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION / INHALATION AN 2016-12-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207625-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION / INHALATION AN 2016-12-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207625-002 LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION / INHALATION AN 2016-12-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207625-003 LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION / INHALATION AN 2016-12-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207625-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION / INHALATION AN 2016-12-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207625-002 LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION / INHALATION AN 2016-12-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207625-003 LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION / INHALATION AN 2016-12-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207625-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION / INHALATION AN 2016-12-30 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 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/3mL
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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 242754 Internal RxNorm lookup 311286 Internal RxNorm lookup 349590 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 81894-103-05 Levalbuterol 5 in 1 POUCH SOLUTION 5 1 81894-103-05 Levalbuterol 3 mL in 1 VIAL, SINGLE-DOSE SOLUTION 3 1 81894-103-25 Levalbuterol 5 in 1 CARTON SOLUTION 5 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81894-103 LEVALBUTEROL SOLUTION [LUOXIN AUROVITAS PHARMA (CHENGDU) CO., LTD.] 1 Current NDC, 3 package rows 20241226_29eae75d-93da-7a5a-e063-6394a90ac0c0.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 81894-103-05 81894010305 5 in 1 POUCH Historical 81894-103-25 81894010325 5 POUCH in 1 CARTON (81894-103-25) / 5 VIAL, SINGLE-DOSE in 1 POUCH (81894-103-05) / 3 mL in 1 VIAL, SINGLE-DOSE 5 pouch 2016-12-30 No No Current