FDA.reportPublic FDA data

Albuterol Sulfate

Product NDC
47335-703
11-digit product format
473350703
Labeler code
47335
Product ID
47335-703_e48295e4-b6c1-434a-aa5f-25d900f1f16a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
albuterol sulfate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA207857
Marketing category
ANDA
Marketing start
2021-06-11
Substance
ALBUTEROL SULFATE
Active strength
.83 mg/mL
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Albuterol Sulfate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALBUTEROL SULFATE.83 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii021SEF3731
Rxcui630208

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
26005090-31a1-441d-920b-db3101a55d53Product name320250221
1c39b897-7219-42a1-9f3a-ec86cfd7b04bProduct name320250218
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
0a278166-c8aa-41b6-b4a5-6ac332bde76aProduct name120230718
c76bcd0f-25eb-471e-b970-1956c95c26c5Product name120230425
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
36390b75-5438-47d3-af60-732a654e9025Product name220220110
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
387afa72-0c5a-0d6b-ee2c-60c3506659e8Product name620210518
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
1b8ea3ec-88bd-98ea-c961-00ae340b5b14Product name220200220
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
3aa5a017-61e9-0c89-adef-13e7964d22f0Product name320171208
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c3c27a99-b8bc-4955-841c-26555f58ee7eProduct name120150421
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
bc98cf6f-a973-7162-5e30-0e7dd8c56bc3Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47335-703-49Albuterol Sulfate5 in 1 CARTONSOLUTION56
47335-703-49Albuterol Sulfate5 in 1 POUCHSOLUTION56
47335-703-52Albuterol Sulfate6 in 1 CARTONSOLUTION66
47335-703-52Albuterol Sulfate5 in 1 POUCHSOLUTION56
47335-703-54Albuterol Sulfate5 in 1 POUCHSOLUTION56
47335-703-54Albuterol Sulfate12 in 1 CARTONSOLUTION126

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-703ALBUTEROL SULFATE SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]5Current NDC, Legacy NDC, 6 package rows20231212_bb538b7d-e390-419a-9404-a57c1db4a447.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
630208albuterol sulfate 0.083 % Inhalation SolutionPSN0f9bf2c8-55c0-4b4d-97de-d6c7220c38626
630208albuterol sulfate 0.083 % Inhalation SolutionPSNbb538b7d-e390-419a-9404-a57c1db4a4476
630208albuterol 0.83 MG/ML Inhalation SolutionSCD0f9bf2c8-55c0-4b4d-97de-d6c7220c38626
630208albuterol 0.83 MG/ML Inhalation SolutionSCDbb538b7d-e390-419a-9404-a57c1db4a4476
630208albuterol 0.083 % Inhalation SolutionSY0f9bf2c8-55c0-4b4d-97de-d6c7220c38626
630208albuterol 0.083 % Inhalation SolutionSYbb538b7d-e390-419a-9404-a57c1db4a4476
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSYbb538b7d-e390-419a-9404-a57c1db4a4476
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSY0f9bf2c8-55c0-4b4d-97de-d6c7220c38626
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSYbb538b7d-e390-419a-9404-a57c1db4a4476
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSY0f9bf2c8-55c0-4b4d-97de-d6c7220c38626
630208albuterol sulfate 0.083 % Inhalation SolutionPSN5de6a189-a8b7-4b33-b162-add6b6e4b2753
630208albuterol sulfate 0.083 % Inhalation SolutionPSNa6545fbe-b0a6-41ae-8bb6-91af38410f563
630208albuterol 0.83 MG/ML Inhalation SolutionSCDa6545fbe-b0a6-41ae-8bb6-91af38410f563
630208albuterol 0.83 MG/ML Inhalation SolutionSCD5de6a189-a8b7-4b33-b162-add6b6e4b2753
630208albuterol 0.083 % Inhalation SolutionSY5de6a189-a8b7-4b33-b162-add6b6e4b2753
630208albuterol 0.083 % Inhalation SolutionSYa6545fbe-b0a6-41ae-8bb6-91af38410f563
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSY5de6a189-a8b7-4b33-b162-add6b6e4b2753
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSYa6545fbe-b0a6-41ae-8bb6-91af38410f563
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSYa6545fbe-b0a6-41ae-8bb6-91af38410f563
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSY5de6a189-a8b7-4b33-b162-add6b6e4b2753
630208albuterol sulfate 0.083 % Inhalation SolutionPSNda44f13e-99d5-6d7a-e053-2a95a90aae651
630208albuterol sulfate 0.083 % Inhalation SolutionPSNddbb0c14-b27f-4be9-e053-2a95a90afc041
630208albuterol 0.83 MG/ML Inhalation SolutionSCDda44f13e-99d5-6d7a-e053-2a95a90aae651
630208albuterol 0.83 MG/ML Inhalation SolutionSCDddbb0c14-b27f-4be9-e053-2a95a90afc041
630208albuterol 0.083 % Inhalation SolutionSYda44f13e-99d5-6d7a-e053-2a95a90aae651
630208albuterol 0.083 % Inhalation SolutionSYddbb0c14-b27f-4be9-e053-2a95a90afc041
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSYda44f13e-99d5-6d7a-e053-2a95a90aae651
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSYddbb0c14-b27f-4be9-e053-2a95a90afc041
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSYda44f13e-99d5-6d7a-e053-2a95a90aae651
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSYddbb0c14-b27f-4be9-e053-2a95a90afc041

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47335-703-49473350703495 POUCH in 1 CARTON (47335-703-49) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL5 pouch2021-06-110000-00-00NoNoCurrent
47335-703-52473350703526 POUCH in 1 CARTON (47335-703-52) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL6 pouch2021-06-110000-00-00NoNoCurrent
47335-703-544733507035412 POUCH in 1 CARTON (47335-703-54) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL12 pouch2021-06-110000-00-00NoNoCurrent