FDA.reportPublic FDA data

Albuterol

Product NDC
69097-021
11-digit product format
690970021
Labeler code
69097
Product ID
69097-021_7d4c1e96-c05f-4ffc-80b6-988986a061bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
Cipla USA Inc.
Application
ANDA219409
Marketing category
ANDA
Marketing start
2026-04-22
Substance
ALBUTEROL SULFATE
Active strength
90 ug/1
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
A219409-001ALBUTEROL SULFATEALBUTEROL SULFATEEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB32026-04-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A219409-001AB3

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
A219409-001CGT2026-12-19

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 06:07:402026-07A219409-001ALBUTEROL SULFATEEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB32026-04-22caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219409-001ALBUTEROL SULFATEEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB32026-04-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A219409-001AB31caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219409-001AB31a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-18 06:07:402026-07A219409-001CGT2026-12-19caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219409-001CGT2026-12-19a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALBUTEROL SULFATE90 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
021SEF3731Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2123076Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fd0389e0-3713-42e0-8ef2-3bb97676fdedAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
26005090-31a1-441d-920b-db3101a55d53Product name320250221
1c39b897-7219-42a1-9f3a-ec86cfd7b04bProduct name320250218
0a278166-c8aa-41b6-b4a5-6ac332bde76aProduct name120230718
c76bcd0f-25eb-471e-b970-1956c95c26c5Product name120230425
36390b75-5438-47d3-af60-732a654e9025Product name220220110
387afa72-0c5a-0d6b-ee2c-60c3506659e8Product name620210518
1b8ea3ec-88bd-98ea-c961-00ae340b5b14Product name220200220
3aa5a017-61e9-0c89-adef-13e7964d22f0Product name320171208
c3c27a99-b8bc-4955-841c-26555f58ee7eProduct name120150421
bc98cf6f-a973-7162-5e30-0e7dd8c56bc3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69097-021-60Albuterol1 in 1 CARTONAEROSOL, METERED12
69097-021-60Albuterol200 in 1 INHALERAEROSOL, METERED2002

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
AlbuterolALBUTEROL SULFATECipla USA Inc.fd0389e0-3713-42e0-8ef2-3bb97676fded2026-01-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219409
application number: ANDA219409
ndc (product): 69097-021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2123076albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuation, generic for VentolinPSNfd0389e0-3713-42e0-8ef2-3bb97676fded2
2123076NDA020983 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCDfd0389e0-3713-42e0-8ef2-3bb97676fded2
2123076albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuation, generic for VentolinSYfd0389e0-3713-42e0-8ef2-3bb97676fded2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69097-021-60690970021601 INHALER in 1 CARTON (69097-021-60) / 200 AEROSOL, METERED in 1 INHALER1 inhaler2026-04-22NoNoCurrent