arformoterol tartrate

Product NDC
70756-612
11-digit product format
707560612
Labeler code
70756
Product ID
70756-612_0cf1c98c-4caf-4eff-b603-6c4b8dd6e148
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
arformoterol tartrate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Lifestar Pharma LLC
Application
ANDA216128
Marketing category
ANDA
Marketing start
2022-11-15
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
2027-12-31
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216128-001ARFORMOTEROL TARTRATEARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONANRS2022-11-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A216128-001AN

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A216128-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONANRS2022-11-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216128-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONANRS2022-11-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216128-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONANRS2022-11-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A216128-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2022-11-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216128-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2022-11-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216128-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2022-11-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216128-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2022-11-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216128-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2022-11-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216128-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2022-11-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216128-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2022-11-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216128-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2022-11-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216128-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2022-11-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216128-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2022-11-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216128-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2022-11-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216128-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2022-11-158072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A216128-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2022-11-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A216128-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2022-11-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A216128-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2022-11-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A216128-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2022-11-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A216128-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2022-11-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A216128-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2022-11-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A216128-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2022-11-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A216128-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2022-11-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A216128-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2022-11-153bdfa0b2c4d7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216128-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONANRS2022-11-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A216128-001AN1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216128-001AN1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216128-001AN131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216128-001AN16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216128-001AN1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216128-001AN1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216128-001AN103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216128-001AN12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216128-001AN15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216128-001AN1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216128-001AN1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216128-001AN179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216128-001AN1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216128-001AN11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216128-001AN18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A216128-001AN16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A216128-001AN11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A216128-001AN1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A216128-001AN1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A216128-001AN19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A216128-001AN1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A216128-001AN13f0d92c62455…
2023-05-13 08:27 UTC2023-05A216128-001AN1053a50430f4f…
2023-01-26 05:58 UTC2023-01A216128-001AN13bdfa0b2c4d7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216128-001AN1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
arformoterol tartrate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARFORMOTEROL TARTRATE15 ug/2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5P8VJ2I235Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
668956Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e9eb1ac7-57aa-4ef8-aac3-14def5b883d0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15e9fde8-93fa-6f6d-5bf2-f94be8a41a73Product name620260202

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70756-612-12arformoterol tartrate2 mL in 1 VIALSOLUTION27
70756-612-12arformoterol tartrate1 in 1 POUCHSOLUTION17
70756-612-44arformoterol tartrate4 in 1 POUCHSOLUTION47
70756-612-44arformoterol tartrate2 mL in 1 VIALSOLUTION27
70756-612-60arformoterol tartrate60 in 1 CARTONSOLUTION607
70756-612-70arformoterol tartrate30 in 1 CARTONSOLUTION307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70756-612-12ML - Milliliter70756-6123509941c-d607-438a-93a0-a48e6e96c85612023-02-06
70756-612-44ML - Milliliter70756-612541aee7f-c42d-45df-b25b-eae8c4021df812023-02-06
70756-612-60ML - Milliliter70756-61272585ec1-eb50-444f-861c-a4339a8b232012023-02-06
70756-612-70ML - Milliliter70756-612966f0d2d-ebca-44e3-a8b2-568a5af5597212023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-612ARFORMOTEROL TARTRATE SOLUTION [LIFESTAR PHARMA LLC]4Current NDC, Legacy NDC, 6 package rows20230318_e9eb1ac7-57aa-4ef8-aac3-14def5b883d0.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
arformoterol tartrateARFORMOTEROL TARTRATELifestar Pharma LLCe9eb1ac7-57aa-4ef8-aac3-14def5b883d02026-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216128
application number: ANDA216128
ndc (product): 70756-612
arformoterol tartrateARFORMOTEROL TARTRATENorthStar RxLLC6a498c49-042f-481f-bc5c-a2fc00dc56682025-12-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216128
application number: ANDA216128

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
668956arformoterol tartrate 15 MCG in 2 ML Inhalation SolutionPSNe9eb1ac7-57aa-4ef8-aac3-14def5b883d07
668956arformoterol 0.0075 MG/ML Inhalation SolutionSCDe9eb1ac7-57aa-4ef8-aac3-14def5b883d07
668956arformoterol 0.0075 MG/ML (arformoterol tartrate 0.011 MG/ML) Inhalation SolutionSYe9eb1ac7-57aa-4ef8-aac3-14def5b883d07
668956arformoterol 15 MCG per 2 ML Inhalation SolutionSYe9eb1ac7-57aa-4ef8-aac3-14def5b883d07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70756-612-12707560612122 mL in 1 VIAL2 mlHistorical
70756-612-44707560612444 in 1 POUCHHistorical
70756-612-607075606126060 POUCH in 1 CARTON (70756-612-60) / 4 VIAL in 1 POUCH (70756-612-44) / 2 mL in 1 VIAL60 pouch2022-11-150000-00-00NoNoCurrent
70756-612-707075606127030 POUCH in 1 CARTON (70756-612-70) / 1 VIAL in 1 POUCH (70756-612-12) / 2 mL in 1 VIAL30 pouch2022-11-150000-00-00NoNoCurrent