FDA.reportPublic FDA data

Albuterol

Product NDC
71205-899
11-digit product format
712050899
Labeler code
71205
Product ID
71205-899_f5ac6375-7f17-4d27-b13a-b44e73281838
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
albuterol
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
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
71205-899-00Albuterol100 in 1 BOTTLETABLET1003
71205-899-11Albuterol1000 in 1 BOTTLETABLET10003
71205-899-30Albuterol30 in 1 BOTTLETABLET303
71205-899-55Albuterol500 in 1 BOTTLETABLET5003
71205-899-60Albuterol60 in 1 BOTTLETABLET603
71205-899-90Albuterol90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-899-00EA - Each71205-899e9d5f56c-94f3-4940-a95a-f2cc2acbcb9312021-09-07
71205-899-11EA - Each71205-899025ab19a-27a3-4b78-9c8e-8746295a872812021-09-07
71205-899-30EA - Each71205-8998838347e-bc0b-46f0-901d-2265728cd5b912021-09-07
71205-899-55EA - Each71205-8994d5a85c5-f9ba-4c41-8332-89feebf3fb5312021-09-07
71205-899-60EA - Each71205-899f0208939-8029-48ab-9de1-f50b6c073f6d12021-09-07
71205-899-90EA - Each71205-8995e63ca06-49da-4af0-aaa3-75a75a2f8c2f12021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-899ALBUTEROL TABLET [PROFICIENT RX LP]3Current NDC, Legacy NDC, 6 package rows20220415_895dff1c-d21c-4470-b021-a5b68364c1ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
71205-899-0071205089900100 TABLET in 1 BOTTLE (71205-899-00) 100 tablet2021-07-300000-00-00NoNoCurrent
71205-899-11712050899111000 TABLET in 1 BOTTLE (71205-899-11) 1000 tablet2021-07-300000-00-00NoNoCurrent
71205-899-307120508993030 TABLET in 1 BOTTLE (71205-899-30) 30 tablet2021-07-300000-00-00NoNoCurrent
71205-899-5571205089955500 TABLET in 1 BOTTLE (71205-899-55) 500 tablet2021-07-300000-00-00NoNoCurrent
71205-899-607120508996060 TABLET in 1 BOTTLE (71205-899-60) 60 tablet2021-07-300000-00-00NoNoCurrent
71205-899-907120508999090 TABLET in 1 BOTTLE (71205-899-90) 90 tablet2021-07-300000-00-00NoNoCurrent