Home NDC 16714-094 Levalbuterol Inhalation Solution
Product NDC 16714-094
11-digit product format 167140094
Labeler code 16714
Product ID 16714-094_a60ea366-65a8-4559-9af5-5afd97875d2e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levalbuterol Inhalation Solution
Dosage form SOLUTION
Route RESPIRATORY (INHALATION)
Labeler NorthStar RxLLC
Application ANDA207820
Marketing category ANDA
Marketing start 2020-05-05
Marketing end 0000-00-00
Substance LEVALBUTEROL HYDROCHLORIDE
Active strength 0 mg/3mL
Pharmacologic classes Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2021-12-31
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A207820-001 LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION / INHALATION 2018-11-05 A207820-002 LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION / INHALATION 2018-11-05 A207820-003 LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION / INHALATION 2018-11-05
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 A207820-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION / INHALATION 2018-11-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207820-002 LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION / INHALATION 2018-11-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207820-003 LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION / INHALATION 2018-11-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207820-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION / INHALATION 2018-11-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207820-002 LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION / INHALATION 2018-11-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207820-003 LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION / INHALATION 2018-11-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207820-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION / INHALATION 2018-11-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207820-002 LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION / INHALATION 2018-11-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207820-003 LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION / INHALATION 2018-11-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207820-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION / INHALATION 2018-11-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207820-002 LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION / INHALATION 2018-11-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207820-003 LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION / INHALATION 2018-11-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207820-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION / INHALATION 2018-11-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207820-002 LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION / INHALATION 2018-11-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207820-003 LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION / INHALATION 2018-11-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207820-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION / INHALATION 2018-11-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207820-002 LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION / INHALATION 2018-11-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207820-003 LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION / INHALATION 2018-11-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207820-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION / INHALATION 2018-11-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207820-002 LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION / INHALATION 2018-11-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207820-003 LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION / INHALATION 2018-11-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207820-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION / INHALATION 2018-11-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207820-002 LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION / INHALATION 2018-11-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207820-003 LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION / INHALATION 2018-11-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207820-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION / INHALATION 2018-11-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207820-002 LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION / INHALATION 2018-11-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207820-003 LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION / INHALATION 2018-11-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207820-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION / INHALATION 2018-11-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207820-002 LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION / INHALATION 2018-11-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207820-003 LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION / INHALATION 2018-11-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207820-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION / INHALATION 2018-11-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207820-002 LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION / INHALATION 2018-11-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207820-003 LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION / INHALATION 2018-11-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207820-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION / INHALATION 2018-11-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207820-002 LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION / INHALATION 2018-11-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207820-003 LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION / INHALATION 2018-11-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207820-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION / INHALATION 2018-11-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207820-002 LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION / INHALATION 2018-11-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207820-003 LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION / INHALATION 2018-11-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207820-001 LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION / INHALATION 2018-11-05 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 81 observed states.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 16714-094-25 16714009425 5 POUCH in 1 CARTON (16714-094-25) > 5 VIAL, SINGLE-DOSE in 1 POUCH > 3 mL in 1 VIAL, SINGLE-DOSE 5 pouch 2020-05-05 0000-00-00 No No Current 16714-094-30 16714009430 6 POUCH in 1 CARTON (16714-094-30) > 5 VIAL, SINGLE-DOSE in 1 POUCH > 3 mL in 1 VIAL, SINGLE-DOSE 6 pouch 2020-05-05 0000-00-00 No No Current