Albuterol Sulfate

Product NDC
0487-9901
11-digit product format
004879901
Labeler code
0487
Product ID
0487-9901_30dbae21-c906-0624-e063-6394a90a299c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Nephron Pharmaceuticals Corporation
Application
ANDA075664
Marketing category
ANDA
Marketing start
2001-06-26
Substance
ALBUTEROL SULFATE
Active strength
2.5 mg/.5mL
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 Sulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALBUTEROL SULFATE2.5 mg/.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii021SEF3731
Rxcui245314

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
0487-9901-02Albuterol Sulfate1 in 1 BAGSOLUTION17
0487-9901-02Albuterol Sulfate30 in 1 BOXSOLUTION307
0487-9901-30Albuterol Sulfate30 in 1 CARTONSOLUTION307
0487-9901-30Albuterol Sulfate1 in 1 POUCHSOLUTION17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0487-9901-02EA - Each0487-9901bc0f25c0-359d-4f7b-90b7-c5c6c1b8722c12012-07-24
0487-9901-30EA - Each0487-9901f8b1f2e3-2853-4f48-8a8a-5241865ad74212012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0487-9901ALBUTEROL SULFATE SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]7Current NDC, Legacy NDC, 4 package rows20250409_ecc00500-58b8-491f-80df-dc6c89a08cae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245314albuterol 0.5 % Inhalation SolutionPSNecc00500-58b8-491f-80df-dc6c89a08cae7
245314albuterol 5 MG/ML Inhalation SolutionSCDecc00500-58b8-491f-80df-dc6c89a08cae7
245314albuterol (as albuterol sulfate) 5 MG/ML Inhalation SolutionSYecc00500-58b8-491f-80df-dc6c89a08cae7
245314albuterol 0.5 % Concentrate for Inhalation SolutionSYecc00500-58b8-491f-80df-dc6c89a08cae7
245314albuterol 1 MG/ML (concentrate 0.5 % ) Inhalation SolutionSYecc00500-58b8-491f-80df-dc6c89a08cae7
245314albuterol 1 MG/ML (concentrate 5 MG/ML) Inhalation SolutionSYecc00500-58b8-491f-80df-dc6c89a08cae7
245314albuterol 2.5 MG per 0.5 ML Concentrate for Inhalation SolutionSYecc00500-58b8-491f-80df-dc6c89a08cae7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0487-9901-020048799010230 BAG in 1 BOX (0487-9901-02) / 1 POUCH in 1 BAG / 1 VIAL, SINGLE-DOSE in 1 POUCH / .5 mL in 1 VIAL, SINGLE-DOSE30 bag2001-06-260000-00-00NoNoCurrent
0487-9901-300048799013030 POUCH in 1 CARTON (0487-9901-30) / 1 VIAL, SINGLE-DOSE in 1 POUCH / .5 mL in 1 VIAL, SINGLE-DOSE30 pouch2001-06-260000-00-00NoNoCurrent