FDA.reportPublic FDA data

Formoterol fumarate

Product NDC
70756-608
11-digit product format
707560608
Labeler code
70756
Product ID
70756-608_7b9fb2fd-635e-47d6-91f3-b1fca2b9dc2a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Formoterol fumarate dihydrate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Lifestar Pharma LLC
Application
ANDA215883
Marketing category
ANDA
Marketing start
2023-03-22
Substance
FORMOTEROL FUMARATE
Active strength
20 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 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
A215883-001FORMOTEROL FUMARATEFORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A215883-001AN

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 UTC2026-02A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-228072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-22053a50430f4f…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215883-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2023-03-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A215883-001AN1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215883-001AN131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215883-001AN16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215883-001AN1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215883-001AN1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215883-001AN103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215883-001AN12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215883-001AN15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215883-001AN1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215883-001AN1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215883-001AN179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215883-001AN1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215883-001AN11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215883-001AN18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215883-001AN16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215883-001AN11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215883-001AN1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215883-001AN1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215883-001AN19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A215883-001AN1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A215883-001AN13f0d92c62455…
2023-05-13 08:27 UTC2023-05A215883-001AN1053a50430f4f…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215883-001AN1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Formoterol fumarate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FORMOTEROL FUMARATE20 ug/2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
W34SHF8J2KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1246319Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
35538d89-a984-4335-acdf-85a893f51eeeAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0c06c4f4-ea2d-4e6a-a22a-0cf292716367Product name420250303
9ab9f611-cedd-47ea-a83c-0489c8c04fc6Product name120231006
a03aea00-1d8b-bfad-a82e-f52f68676f63Product name220221216
7d8c8d5a-f174-4e6b-97b1-6fd615c5df9aProduct name120210204
1cbe9071-502b-482d-9c24-839b43446576Product name120200123
58f15a44-d9d2-4d61-a39d-7f0223302a8fProduct name120190702
ce066c73-ca6f-49fc-83d4-d3cf6728e8a1Product name120160616

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70756-608-12Formoterol fumarate2 mL in 1 VIALSOLUTION210
70756-608-12Formoterol fumarate1 in 1 POUCHSOLUTION110
70756-608-44Formoterol fumarate2 mL in 1 VIALSOLUTION210
70756-608-44Formoterol fumarate4 in 1 POUCHSOLUTION410
70756-608-60Formoterol fumarate60 in 1 CARTONSOLUTION6010
70756-608-70Formoterol fumarate30 in 1 CARTONSOLUTION3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70756-608-12ML - Milliliter70756-6089fda2065-e352-45b8-9dea-15d7022c8d2712023-06-06
70756-608-44ML - Milliliter70756-6087ecdbee2-2036-447b-a95f-db792ccdb1e612026-05-22
70756-608-60ML - Milliliter70756-60869b6b8b2-edd2-47bc-821f-e509b7e0bc9c12023-05-05
70756-608-70ML - Milliliter70756-608eb2bb37d-7184-4db9-a953-e48522a5a82d12023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-608FORMOTEROL FUMARATE (FORMOTEROL FUMARATE DIHYDRATE) SOLUTION [LIFESTAR PHARMA LLC]9Current NDC, 6 package rows20250419_35538d89-a984-4335-acdf-85a893f51eee.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
Formoterol fumarateFORMOTEROL FUMARATE DIHYDRATENorthStar RxLLC4dbb9620-5731-40d9-8258-2977ecc781c42026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215883
application number: ANDA215883
Formoterol fumarateFORMOTEROL FUMARATE DIHYDRATELifestar Pharma LLC35538d89-a984-4335-acdf-85a893f51eee2026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215883
application number: ANDA215883
ndc (product): 70756-608

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1246319formoterol fumarate 20 MCG in 2 ML Inhalation SolutionPSN35538d89-a984-4335-acdf-85a893f51eee10
1246319formoterol fumarate 0.01 MG/ML Inhalation SolutionSCD35538d89-a984-4335-acdf-85a893f51eee10
1246319formoterol fumarate 20 MCG per 2 ML Inhalation SolutionSY35538d89-a984-4335-acdf-85a893f51eee10
1246319formoterol fumarate 20 MCG/2 ML Inhalation SolutionSY35538d89-a984-4335-acdf-85a893f51eee10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70756-608-12707560608122 mL in 1 VIAL2 mlHistorical
70756-608-44707560608442 mL in 1 VIAL2 mlHistorical
70756-608-607075606086060 POUCH in 1 CARTON (70756-608-60) / 4 VIAL in 1 POUCH (70756-608-44) / 2 mL in 1 VIAL60 pouch2023-03-22NoNoCurrent
70756-608-707075606087030 POUCH in 1 CARTON (70756-608-70) / 1 VIAL in 1 POUCH (70756-608-12) / 2 mL in 1 VIAL30 pouch2023-03-22NoNoCurrent