Arformoterol Tartrate

Product NDC
70748-257
Requested package NDC
70748-257-30
11-digit product format
707480257
Labeler code
70748
Product ID
70748-257_c73ec4be-17c1-4184-a43d-03dde0504a4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Arformoterol Tartrate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Lupin Pharmaceuticals, Inc.
Application
NDA021912
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2021-06-01
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70748-25770748-257-30DDiscontinued by firm2026-08-11

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021912-001BROVANAARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONRLD2006-10-06

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021912-001BROVANAEQ 0.015MG BASE/2MLSOLUTION / INHALATIONRLD2006-10-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021912-001BROVANAEQ 0.015MG BASE/2MLSOLUTION / INHALATIONRLD2006-10-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08N021912-001BROVANAEQ 0.015MG BASE/2MLSOLUTION / INHALATIONANRLD, RS2006-10-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021912-001BROVANAEQ 0.015MG BASE/2MLSOLUTION / INHALATIONANRLD, RS2006-10-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021912-001BROVANAEQ 0.015MG BASE/2MLSOLUTION / INHALATIONANRLD, RS2006-10-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021912-001BROVANAEQ 0.015MG BASE/2MLSOLUTION / INHALATIONANRLD, RS2006-10-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021912-001BROVANAEQ 0.015MG BASE/2MLSOLUTION / INHALATIONANRLD, RS2006-10-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021912-001BROVANAEQ 0.015MG BASE/2MLSOLUTION / INHALATIONANRLD, RS2006-10-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021912-001BROVANAEQ 0.015MG BASE/2MLSOLUTION / INHALATIONANRLD, RS2006-10-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021912-001BROVANAEQ 0.015MG BASE/2MLSOLUTION / INHALATIONANRLD, RS2006-10-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021912-001BROVANAEQ 0.015MG BASE/2MLSOLUTION / INHALATIONANRLD, RS2006-10-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021912-001BROVANAEQ 0.015MG BASE/2MLSOLUTION / INHALATIONANRLD, RS2006-10-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021912-001BROVANAEQ 0.015MG BASE/2MLSOLUTION / INHALATIONANRLD, RS2006-10-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021912-001BROVANAEQ 0.015MG BASE/2MLSOLUTION / INHALATIONANRLD, RS2006-10-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021912-001BROVANAEQ 0.015MG BASE/2MLSOLUTION / INHALATIONANRLD, RS2006-10-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021912-001BROVANAEQ 0.015MG BASE/2MLSOLUTION / INHALATIONANRLD, RS2006-10-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021912-001BROVANAEQ 0.015MG BASE/2MLSOLUTION / INHALATIONANRLD, RS2006-10-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021912-001BROVANAEQ 0.015MG BASE/2MLSOLUTION / INHALATIONRLD, RS2006-10-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021912-001BROVANAEQ 0.015MG BASE/2MLSOLUTION / INHALATIONANRLD, RS2006-10-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021912-001BROVANAEQ 0.015MG BASE/2MLSOLUTION / INHALATIONANRLD, RS2006-10-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021912-001BROVANAEQ 0.015MG BASE/2MLSOLUTION / INHALATIONRLD, RS2006-10-0687673890dc5c…
2021-03-12 10:30 UTC2021-03N021912-001BROVANAEQ 0.015MG BASE/2MLSOLUTION / INHALATIONRLD, RS2006-10-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021912-001BROVANAEQ 0.015MG BASE/2MLSOLUTION / INHALATIONRLD, RS2006-10-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021912-001BROVANAEQ 0.015MG BASE/2MLSOLUTION / INHALATIONRLD, RS2006-10-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021912-001BROVANAEQ 0.015MG BASE/2MLSOLUTION / INHALATIONRLD, RS2006-10-063f01610625f2…
2019-09-15 20:21 UTC2019-09N021912-001BROVANAEQ 0.015MG BASE/2MLSOLUTION / INHALATIONRLD, RS2006-10-06b00525d2431f…
2019-07-19 19:46 UTC2019-07N021912-001BROVANAEQ 0.015MG BASE/2MLSOLUTION / INHALATIONRLD, RS2006-10-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021912-001BROVANAEQ 0.015MG BASE/2MLSOLUTION / INHALATIONANRLD, RS2006-10-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021912-001BROVANAEQ 0.015MG BASE/2MLSOLUTION / INHALATIONANRLD, RS2006-10-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021912-001BROVANAEQ 0.015MG BASE/2MLSOLUTION / INHALATIONANRLD, RS2006-10-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021912-001BROVANAEQ 0.015MG BASE/2MLSOLUTION / INHALATIONANRLD, RS2006-10-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021912-001BROVANAEQ 0.015MG BASE/2MLSOLUTION / INHALATIONANRLD, RS2006-10-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021912-001BROVANAEQ 0.015MG BASE/2MLSOLUTION / INHALATIONANRLD, RS2006-10-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021912-001BROVANAEQ 0.015MG BASE/2MLSOLUTION / INHALATIONANRLD, RS2006-10-063f0d92c62455…
2023-05-13 08:27 UTC2023-05N021912-001BROVANAEQ 0.015MG BASE/2MLSOLUTION / INHALATIONANRLD, RS2006-10-06053a50430f4f…
2023-01-26 05:58 UTC2023-01N021912-001BROVANAEQ 0.015MG BASE/2MLSOLUTION / INHALATIONANRLD, RS2006-10-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021912-001BROVANAEQ 0.015MG BASE/2MLSOLUTION / INHALATIONANRLD, RS2006-10-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021912-001BROVANAEQ 0.015MG BASE/2MLSOLUTION / INHALATIONANRLD, RS2006-10-06f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021912-001BROVANAEQ 0.015MG BASE/2MLSOLUTION / INHALATIONANRLD, RS2006-10-06e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021912-001BROVANAEQ 0.015MG BASE/2MLSOLUTION / INHALATIONANRLD, RS2006-10-06cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-08-23 18:47 UTC2025-08N021912-001AN16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021912-001AN1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021912-001AN1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021912-001AN103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021912-001AN12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021912-001AN15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021912-001AN1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021912-001AN1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021912-001AN179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021912-001AN1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021912-001AN11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021912-001AN18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021912-001AN15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021912-001AN15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021912-001AN14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N021912-001AN1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021912-001AN1782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021912-001AN16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021912-001AN11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021912-001AN1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021912-001AN1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021912-001AN19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021912-001AN1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021912-001AN13f0d92c62455…
2023-05-13 08:27 UTC2023-05N021912-001AN1053a50430f4f…
2023-01-26 05:58 UTC2023-01N021912-001AN13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021912-001AN13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021912-001AN1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021912-001AN1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021912-001AN1cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 3 · 99 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021912-00166673442021-06-22Drug product2012-06-0174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021912-00168149532021-06-22U-7932012-06-0174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021912-00173483622021-06-22U-793Drug product2013-07-1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021912-00174626452021-06-22U-7932013-07-1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021912-00174657562021-06-22Drug product2013-07-1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021912-00174737102021-06-22U-7932013-07-1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021912-00175413852021-06-22U-7932013-07-1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021912-00164725632021-11-09Drug substance74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021912-00167204532021-11-09Drug substance74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021912-00171450362021-11-09Drug substance74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021912-00181107062021-11-09Drug product2012-02-0974a2ff9319b5…
2021-12-28 21:50 UTC2021-12N021912-00166673442021-06-22Drug product2012-06-01782e0a99824c…
2021-12-28 21:50 UTC2021-12N021912-00168149532021-06-22U-7932012-06-01782e0a99824c…
2021-12-28 21:50 UTC2021-12N021912-00173483622021-06-22U-793Drug product2013-07-11782e0a99824c…
2021-12-28 21:50 UTC2021-12N021912-00174626452021-06-22U-7932013-07-11782e0a99824c…
2021-12-28 21:50 UTC2021-12N021912-00174657562021-06-22Drug product2013-07-11782e0a99824c…
2021-12-28 21:50 UTC2021-12N021912-00174737102021-06-22U-7932013-07-11782e0a99824c…
2021-12-28 21:50 UTC2021-12N021912-00175413852021-06-22U-7932013-07-11782e0a99824c…
2021-12-28 21:50 UTC2021-12N021912-00164725632021-11-09Drug substance782e0a99824c…
2021-12-28 21:50 UTC2021-12N021912-00167204532021-11-09Drug substance782e0a99824c…
2021-12-28 21:50 UTC2021-12N021912-00171450362021-11-09Drug substance782e0a99824c…
2021-12-28 21:50 UTC2021-12N021912-00181107062021-11-09Drug product2012-02-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021912-00166673442021-06-22Drug product2012-06-0187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021912-00168149532021-06-22U-7932012-06-0187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021912-00173483622021-06-22U-793Drug product2013-07-1187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021912-00174626452021-06-22U-7932013-07-1187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021912-00174657562021-06-22Drug product2013-07-1187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021912-00174737102021-06-22U-7932013-07-1187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021912-00175413852021-06-22U-7932013-07-1187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021912-00164725632021-11-09Drug substance87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021912-00167204532021-11-09Drug substance87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021912-00171450362021-11-09Drug substance87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021912-00181107062021-11-09Drug product2012-02-0987673890dc5c…
2021-03-12 10:30 UTC2021-03N021912-00166673442021-06-22Drug product2012-06-015aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021912-00168149532021-06-22U-7932012-06-015aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021912-00173483622021-06-22U-793Drug product2013-07-115aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021912-00174626452021-06-22U-7932013-07-115aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021912-00174657562021-06-22Drug product2013-07-115aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021912-00174737102021-06-22U-7932013-07-115aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021912-00175413852021-06-22U-7932013-07-115aa47cf7b7d7…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70748-257-01ML - Milliliter70748-257073c679d-7d7b-456a-837b-717c9208494e12021-07-15
70748-257-04ML - Milliliter70748-257533f0850-ce16-4602-aa8f-6da70bd67f3e12021-07-15
70748-257-30ML - Milliliter70748-257224d00b8-2278-48d1-a8df-fff962d7899d12021-06-02
70748-257-60ML - Milliliter70748-2577a01fca6-d81a-4b89-a7de-15d7fdd1928912021-06-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70748-257-307074802573030 POUCH in 1 CARTON (70748-257-30) > 1 VIAL, SINGLE-DOSE in 1 POUCH (70748-257-01) > 2 mL in 1 VIAL, SINGLE-DOSE30 pouch2021-06-010000-00-00NoNoCurrent