Home NDC 72603-208 arformoterol tartrate
Product NDC 72603-208
11-digit product format 726030208
Labeler code 72603
Product ID 72603-208_c3d670fd-671b-4c32-a9ca-448dc6a49c66
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name arformoterol tartrate
Dosage form SOLUTION
Route RESPIRATORY (INHALATION)
Labeler NorthStar RxLLC
Application ANDA216128
Marketing category ANDA
Marketing start 2024-06-01
Substance ARFORMOTEROL TARTRATE
Active strength 15 ug/2mL
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 42 .
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 A216128-001 ARFORMOTEROL TARTRATE ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION AN RS 2022-11-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216128-001 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.
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 A216128-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION AN RS 2022-11-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216128-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION AN RS 2022-11-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216128-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION AN RS 2022-11-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216128-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION AN 2022-11-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216128-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION AN 2022-11-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216128-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION AN 2022-11-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216128-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION AN 2022-11-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216128-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION AN 2022-11-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216128-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION AN 2022-11-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216128-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION AN 2022-11-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216128-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION AN 2022-11-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216128-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION AN 2022-11-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216128-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION AN 2022-11-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216128-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION AN 2022-11-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216128-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION AN 2022-11-15 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216128-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION AN 2022-11-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216128-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION AN 2022-11-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216128-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION AN 2022-11-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216128-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION AN 2022-11-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216128-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION AN 2022-11-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216128-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION AN 2022-11-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216128-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION AN 2022-11-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A216128-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION AN 2022-11-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A216128-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION AN 2022-11-15 3bdfa0b2c4d7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216128-001 ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION / INHALATION AN RS 2022-11-15 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base arformoterol tartrate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ARFORMOTEROL TARTRATE 15 ug/2mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5P8VJ2I235 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 668956 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 72603-208-01 arformoterol tartrate 2 mL in 1 VIAL SOLUTION 2 3 72603-208-01 arformoterol tartrate 1 in 1 POUCH SOLUTION 1 3 72603-208-04 arformoterol tartrate 4 in 1 POUCH SOLUTION 4 3 72603-208-04 arformoterol tartrate 2 mL in 1 VIAL SOLUTION 2 3 72603-208-30 arformoterol tartrate 30 in 1 CARTON SOLUTION 30 3 72603-208-60 arformoterol tartrate 60 in 1 CARTON SOLUTION 60 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72603-208 ARFORMOTEROL TARTRATE SOLUTION [NORTHSTAR RXLLC] 2 Current NDC, 6 package rows 20240601_6a498c49-042f-481f-bc5c-a2fc00dc5668.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 72603-208-01 72603020801 2 mL in 1 VIAL 2 ml Historical 72603-208-04 72603020804 4 in 1 POUCH Historical 72603-208-30 72603020830 30 POUCH in 1 CARTON (72603-208-30) / 1 VIAL in 1 POUCH (72603-208-01) / 2 mL in 1 VIAL 30 pouch 2024-06-01 No No Current 72603-208-60 72603020860 60 POUCH in 1 CARTON (72603-208-60) / 4 VIAL in 1 POUCH (72603-208-04) / 2 mL in 1 VIAL 60 pouch 2024-06-01 No No Current