Albuterol Sulfate

Product NDC
68071-2656
11-digit product format
680712656
Labeler code
68071
Product ID
68071-2656_da44f13e-99d6-6d7a-e053-2a95a90aae65
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
albuterol sulfate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA207857
Marketing category
ANDA
Marketing start
2021-06-11
Marketing end
0000-00-00
Substance
ALBUTEROL SULFATE
Active strength
1 mg/mL
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2656-2Albuterol Sulfate5 in 1 POUCHSOLUTION51
68071-2656-2Albuterol Sulfate5 in 1 CARTONSOLUTION51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2656ALBUTEROL SULFATE SOLUTION [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 2 package rows20220316_da44f13e-99d5-6d7a-e053-2a95a90aae65.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
630208albuterol sulfate 0.083 % Inhalation SolutionPSNda44f13e-99d5-6d7a-e053-2a95a90aae651
630208albuterol 0.83 MG/ML Inhalation SolutionSCDda44f13e-99d5-6d7a-e053-2a95a90aae651
630208albuterol 0.083 % Inhalation SolutionSYda44f13e-99d5-6d7a-e053-2a95a90aae651
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSYda44f13e-99d5-6d7a-e053-2a95a90aae651
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSYda44f13e-99d5-6d7a-e053-2a95a90aae651

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2656-2680712656025 POUCH in 1 CARTON (68071-2656-2) > 5 VIAL in 1 POUCH > 3 mL in 1 VIAL5 pouch2022-03-150000-00-00NoNoCurrent