FDA.reportPublic FDA data

Albuterol Sulfate Inhalation

Product NDC
69238-1291
11-digit product format
692381291
Labeler code
69238
Product ID
69238-1291_881ca107-7a62-40e0-8936-89bc2d16cfa6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
INHALANT
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA211600
Marketing category
ANDA
Marketing start
2025-12-03
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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A211600-001ALBUTEROL SULFATEALBUTEROL SULFATEEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB22025-12-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211600-001AB2

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
2026-09-14 22:38:342026-08A211600-001ALBUTEROL SULFATEEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB22025-12-0184e616aacf4f…
2026-08-18 06:07:402026-07A211600-001ALBUTEROL SULFATEEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB22025-12-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211600-001ALBUTEROL SULFATEEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB22025-12-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211600-001ALBUTEROL SULFATEEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB22025-12-0131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211600-001ALBUTEROL SULFATEEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB22025-12-01a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A211600-001AB2184e616aacf4f…
2026-08-18 06:07:402026-07A211600-001AB21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211600-001AB21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211600-001AB2131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211600-001AB21a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Albuterol Sulfate Inhalation
Listing expiration
2026-12-31

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
2123072Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2e449282-ee58-4e36-b983-85c4e6f0864dAvailable 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
69238-1291-1Albuterol Sulfate Inhalation200 in 1 CANISTERINHALANT20014
69238-1291-1Albuterol Sulfate Inhalation1 in 1 CARTONINHALANT114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1291-1GM - Gram69238-12918a3ba9a8-c126-4416-bb59-a6378ca38fc512026-04-20

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
Albuterol Sulfate InhalationALBUTEROL SULFATEAmneal Pharmaceuticals NY LLC2e449282-ee58-4e36-b983-85c4e6f0864d2024-12-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211600
application number: ANDA211600
ndc (product): 69238-1291

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2123072albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProAirPSN2e449282-ee58-4e36-b983-85c4e6f0864d14
2123072NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCD2e449282-ee58-4e36-b983-85c4e6f0864d14
2123072albuterol 90 MCG/ACTUAT Metered Dose Inhaler, 200 Actuations, generic for ProAirSY2e449282-ee58-4e36-b983-85c4e6f0864d14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69238-1291-1692381291011 CANISTER in 1 CARTON (69238-1291-1) / 200 INHALANT in 1 CANISTER1 canister2025-12-03NoNoCurrent