FDA.reportPublic FDA data

Albuterol

Product NDC
64980-443
11-digit product format
649800443
Labeler code
64980
Product ID
64980-443_f3d2f709-6e2e-4c25-8069-52661dc76e2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
albuterol
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA207046
Marketing category
ANDA
Marketing start
2018-06-29
Substance
ALBUTEROL SULFATE
Active strength
4 mg/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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALBUTEROL SULFATE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii021SEF3731
Rxcui197316, 197318

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
64980-443-01Albuterol100 in 1 BOTTLETABLET1004
64980-443-50Albuterol500 in 1 BOTTLETABLET5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-443-01EA - Each64980-44342b690eb-5ac5-4927-b883-c3c053d9c6e712018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-443ALBUTEROL TABLET [RISING PHARMA HOLDINGS, INC.]4Current NDC, Legacy NDC, 2 package rows20250326_40f3cdbc-c9ee-4a3c-8061-a44b9a1d035c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197318albuterol 4 MG Oral TabletPSN601a18ed-d66e-498f-a804-f1a3330827d4102
197318albuterol 4 MG Oral TabletSCD601a18ed-d66e-498f-a804-f1a3330827d4102
197318albuterol 4 MG (as albuterol sulfate 4.8 MG) Oral TabletSY601a18ed-d66e-498f-a804-f1a3330827d4102
197316albuterol 2 MG Oral TabletPSN40f3cdbc-c9ee-4a3c-8061-a44b9a1d035c4
197318albuterol 4 MG Oral TabletPSN40f3cdbc-c9ee-4a3c-8061-a44b9a1d035c4
197316albuterol 2 MG Oral TabletSCD40f3cdbc-c9ee-4a3c-8061-a44b9a1d035c4
197318albuterol 4 MG Oral TabletSCD40f3cdbc-c9ee-4a3c-8061-a44b9a1d035c4
197316albuterol 2 MG (as albuterol sulfate 2.4 MG) Oral TabletSY40f3cdbc-c9ee-4a3c-8061-a44b9a1d035c4
197318albuterol 4 MG (as albuterol sulfate 4.8 MG) Oral TabletSY40f3cdbc-c9ee-4a3c-8061-a44b9a1d035c4
197316albuterol 2 MG Oral TabletPSN895dff1c-d21c-4470-b021-a5b68364c1ec3
197318albuterol 4 MG Oral TabletPSN895dff1c-d21c-4470-b021-a5b68364c1ec3
197316albuterol 2 MG Oral TabletSCD895dff1c-d21c-4470-b021-a5b68364c1ec3
197318albuterol 4 MG Oral TabletSCD895dff1c-d21c-4470-b021-a5b68364c1ec3
197316albuterol 2 MG (as albuterol sulfate 2.4 MG) Oral TabletSY895dff1c-d21c-4470-b021-a5b68364c1ec3
197318albuterol 4 MG (as albuterol sulfate 4.8 MG) Oral TabletSY895dff1c-d21c-4470-b021-a5b68364c1ec3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64980-443-0164980044301100 TABLET in 1 BOTTLE (64980-443-01) 100 tablet2018-06-290000-00-00NoNoCurrent
64980-443-5064980044350500 TABLET in 1 BOTTLE (64980-443-50) 500 tablet2018-06-290000-00-00NoNoCurrent