Arformoterol Tartrate Inhalation

Product NDC
70436-151
Requested package NDC
70436-151-57
11-digit product format
704360151
Labeler code
70436
Product ID
70436-151_3bd6ebed-0405-445a-8613-ae20b2e70703
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Arformoterol Tartrate Inhalation
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Slate Run Pharmaceuticals
Application
ANDA213762
Marketing category
ANDA
Marketing start
2021-06-22
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 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
A213762-001ARFORMOTEROL TARTRATEARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2021-06-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213762-001AN

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
2026-02-19 14:30 UTC2026-02A213762-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2021-06-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213762-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2021-06-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A213762-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2021-06-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213762-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2021-06-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213762-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2021-06-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213762-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2021-06-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213762-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2021-06-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213762-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2021-06-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213762-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2021-06-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213762-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2021-06-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213762-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2021-06-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213762-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2021-06-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213762-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2021-06-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213762-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2021-06-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213762-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2021-06-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213762-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2021-06-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213762-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2021-06-224b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213762-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2021-06-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213762-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2021-06-22782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213762-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2021-06-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213762-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2021-06-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213762-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2021-06-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213762-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2021-06-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213762-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2021-06-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213762-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2021-06-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213762-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2021-06-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A213762-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2021-06-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A213762-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2021-06-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213762-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2021-06-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A213762-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2021-06-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A213762-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2021-06-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A213762-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2021-06-22cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213762-001ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION / INHALATIONAN2021-06-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A213762-001AN1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213762-001AN131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213762-001AN16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213762-001AN1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213762-001AN1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213762-001AN103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213762-001AN12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213762-001AN15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213762-001AN1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213762-001AN1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213762-001AN179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213762-001AN1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213762-001AN11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213762-001AN18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213762-001AN15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213762-001AN15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213762-001AN14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213762-001AN1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213762-001AN1782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213762-001AN16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213762-001AN11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213762-001AN1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213762-001AN1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213762-001AN19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213762-001AN1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213762-001AN13f0d92c62455…
2023-05-13 08:27 UTC2023-05A213762-001AN1053a50430f4f…
2023-01-26 05:58 UTC2023-01A213762-001AN13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213762-001AN13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A213762-001AN1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A213762-001AN1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A213762-001AN1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213762-001AN1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Arformoterol Tartrate Inhalation
Listing expiration
2026-12-31

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
7d639762-091b-471e-9355-c2f4737676a2Available 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
70436-151-19Arformoterol Tartrate Inhalation1 in 1 POUCHSOLUTION14
70436-151-19Arformoterol Tartrate Inhalation2 mL in 1 VIALSOLUTION24
70436-151-20Arformoterol Tartrate Inhalation4 in 1 POUCHSOLUTION44
70436-151-20Arformoterol Tartrate Inhalation2 mL in 1 VIALSOLUTION24
70436-151-57Arformoterol Tartrate Inhalation30 in 1 CARTONSOLUTION304
70436-151-58Arformoterol Tartrate Inhalation15 in 1 CARTONSOLUTION154

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70436-151-19ML - Milliliter70436-151a241f59e-95a6-4717-8000-bfcabc83fb5912021-07-15
70436-151-20ML - Milliliter70436-1512d91895f-1c6f-432e-9b96-be944954704812021-07-15
70436-151-57ML - Milliliter70436-15115c2222e-6bb8-4f63-8b67-5439d08cd1da12021-07-15
70436-151-58ML - Milliliter70436-15174131405-0f95-4f38-91aa-f32ac46b49e712021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70436-151ARFORMOTEROL TARTRATE INHALATION SOLUTION [SLATE RUN PHARMACEUTICALS]4Current NDC, Legacy NDC, 6 package rows20230127_7d639762-091b-471e-9355-c2f4737676a2.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Arformoterol Tartrate InhalationARFORMOTEROL TARTRATE INHALATIONSlate Run Pharmaceuticals7d639762-091b-471e-9355-c2f4737676a22023-01-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213762
application number: ANDA213762
ndc (package): 70436-151-57
ndc (product): 70436-151
ndc11 (package): 70436015157

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
668956arformoterol tartrate 15 MCG in 2 ML Inhalation SolutionPSN7d639762-091b-471e-9355-c2f4737676a24
668956arformoterol 0.0075 MG/ML Inhalation SolutionSCD7d639762-091b-471e-9355-c2f4737676a24
668956arformoterol 0.0075 MG/ML (arformoterol tartrate 0.011 MG/ML) Inhalation SolutionSY7d639762-091b-471e-9355-c2f4737676a24
668956arformoterol 15 MCG per 2 ML Inhalation SolutionSY7d639762-091b-471e-9355-c2f4737676a24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70436-151-577043601515730 POUCH in 1 CARTON (70436-151-57) / 1 VIAL in 1 POUCH (70436-151-19) / 2 mL in 1 VIAL30 pouch2021-06-220000-00-00NoNoCurrent