Albuterol

Product NDC
70710-1061
11-digit product format
707101061
Labeler code
70710
Product ID
70710-1061_1d5b3219-efd5-4842-9b6e-2ea1874d0d4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA208884
Marketing category
ANDA
Marketing start
2020-10-23
Substance
ALBUTEROL SULFATE
Active strength
2 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 SULFATE2 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
70710-1061-1Albuterol100 in 1 BOTTLETABLET1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1061-1EA - Each70710-1061e6655b9b-6e8b-427d-9b46-1252ac18e89a12021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1061ALBUTEROL TABLET [ZYDUS PHARMACEUTICALS USA INC.]3Current NDC, Legacy NDC, 1 package rows20230901_c3fa0068-fd12-45de-818e-e929fb45ba05.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197316albuterol 2 MG Oral TabletPSNc3fa0068-fd12-45de-818e-e929fb45ba053
197318albuterol 4 MG Oral TabletPSNc3fa0068-fd12-45de-818e-e929fb45ba053
197316albuterol 2 MG Oral TabletSCDc3fa0068-fd12-45de-818e-e929fb45ba053
197318albuterol 4 MG Oral TabletSCDc3fa0068-fd12-45de-818e-e929fb45ba053
197316albuterol 2 MG (as albuterol sulfate 2.4 MG) Oral TabletSYc3fa0068-fd12-45de-818e-e929fb45ba053
197318albuterol 4 MG (as albuterol sulfate 4.8 MG) Oral TabletSYc3fa0068-fd12-45de-818e-e929fb45ba053

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70710-1061-170710106101100 TABLET in 1 BOTTLE (70710-1061-1) 100 tablet2020-10-230000-00-00NoNoCurrent