FDA.reportPublic FDA data

Formoterol Fumarate

Product NDC
62332-655
11-digit product format
623320655
Labeler code
62332
Product ID
62332-655_99e63a2d-5d11-43b4-ba83-1d64f3fc3914
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Formoterol Fumarate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA215078
Marketing category
ANDA
Marketing start
2021-11-22
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
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
A215078-001FORMOTEROL FUMARATEFORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2021-11-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A215078-001AN

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 UTC2026-02A215078-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2021-11-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215078-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2021-11-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A215078-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2021-11-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215078-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2021-11-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215078-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2021-11-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215078-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2021-11-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215078-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2021-11-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215078-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2021-11-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215078-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2021-11-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215078-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2021-11-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215078-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2021-11-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215078-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2021-11-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215078-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2021-11-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215078-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2021-11-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215078-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2021-11-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A215078-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2021-11-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A215078-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2021-11-224b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A215078-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2021-11-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A215078-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2021-11-22782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215078-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2021-11-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215078-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2021-11-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215078-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2021-11-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215078-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2021-11-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215078-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2021-11-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A215078-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2021-11-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A215078-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2021-11-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A215078-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2021-11-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A215078-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2021-11-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A215078-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2021-11-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A215078-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2021-11-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A215078-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2021-11-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A215078-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2021-11-22cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215078-001FORMOTEROL FUMARATE0.02MG/2MLSOLUTION / INHALATIONAN2021-11-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A215078-001AN1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215078-001AN131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215078-001AN16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215078-001AN1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215078-001AN1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215078-001AN103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215078-001AN12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215078-001AN15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215078-001AN1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215078-001AN1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215078-001AN179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215078-001AN1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215078-001AN11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215078-001AN18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215078-001AN15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A215078-001AN15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A215078-001AN14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A215078-001AN1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A215078-001AN1782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215078-001AN16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215078-001AN11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215078-001AN1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215078-001AN1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215078-001AN19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A215078-001AN1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A215078-001AN13f0d92c62455…
2023-05-13 08:27 UTC2023-05A215078-001AN1053a50430f4f…
2023-01-26 05:58 UTC2023-01A215078-001AN13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A215078-001AN13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A215078-001AN1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A215078-001AN1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A215078-001AN1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215078-001AN1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Formoterol Fumarate
Listing expiration
2026-12-31

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
07afdf7e-c480-4806-b469-a6a460522bc0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0c06c4f4-ea2d-4e6a-a22a-0cf292716367Product name420250303
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9ab9f611-cedd-47ea-a83c-0489c8c04fc6Product name120231006
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
a03aea00-1d8b-bfad-a82e-f52f68676f63Product name220221216
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
7d8c8d5a-f174-4e6b-97b1-6fd615c5df9aProduct name120210204
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
1cbe9071-502b-482d-9c24-839b43446576Product name120200123
58f15a44-d9d2-4d61-a39d-7f0223302a8fProduct name120190702
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ce066c73-ca6f-49fc-83d4-d3cf6728e8a1Product name120160616
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62332-655-01Formoterol Fumarate2 mL in 1 VIALSOLUTION212
62332-655-01Formoterol Fumarate1 in 1 POUCHSOLUTION112
62332-655-30Formoterol Fumarate30 in 1 CARTONSOLUTION3012
62332-655-60Formoterol Fumarate1 in 1 POUCHSOLUTION112
62332-655-60Formoterol Fumarate60 in 1 CARTONSOLUTION6012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-655-01ML - Milliliter62332-6558d83b796-16a2-4fcc-82e7-50d53b8dd28a12022-03-09
62332-655-30ML - Milliliter62332-655c44f1035-778c-4ce1-91b5-e5f9124e151412022-03-09
62332-655-60ML - Milliliter62332-65559f28dc4-24d8-44af-ad2e-2f6a66a0b15b12022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-655FORMOTEROL FUMARATE SOLUTION [ALEMBIC PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 5 package rows20250207_07afdf7e-c480-4806-b469-a6a460522bc0.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
Formoterol FumarateFORMOTEROL FUMARATEAlembic Pharmaceuticals Inc.07afdf7e-c480-4806-b469-a6a460522bc02025-12-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215078
application number: ANDA215078
ndc (product): 62332-655

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1246319formoterol fumarate 20 MCG in 2 ML Inhalation SolutionPSN07afdf7e-c480-4806-b469-a6a460522bc012
1246319formoterol fumarate 0.01 MG/ML Inhalation SolutionSCD07afdf7e-c480-4806-b469-a6a460522bc012
1246319formoterol fumarate 20 MCG per 2 ML Inhalation SolutionSY07afdf7e-c480-4806-b469-a6a460522bc012
1246319formoterol fumarate 20 MCG/2 ML Inhalation SolutionSY07afdf7e-c480-4806-b469-a6a460522bc012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-655-01623320655012 mL in 1 VIAL2 mlHistorical
62332-655-306233206553030 POUCH in 1 CARTON (62332-655-30) / 1 VIAL in 1 POUCH (62332-655-01) / 2 mL in 1 VIAL30 pouch2021-11-220000-00-00NoNoCurrent
62332-655-606233206556060 POUCH in 1 CARTON (62332-655-60) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL60 pouch2021-11-220000-00-00NoNoCurrent