FDA.reportPublic FDA data

Albuterol Sulfate

Product NDC
0487-9501
11-digit product format
004879501
Labeler code
0487
Product ID
0487-9501_43071d13-87b9-6cff-e063-6394a90aff2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Nephron Pharmaceuticals Corporation
Application
ANDA074880
Marketing category
ANDA
Marketing start
1997-09-17
Substance
ALBUTEROL SULFATE
Active strength
2.5 mg/3mL
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/3mL

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
0487-9501-01Albuterol Sulfate30 in 1 CARTONSOLUTION309
0487-9501-01Albuterol Sulfate1 in 1 POUCHSOLUTION19
0487-9501-03Albuterol Sulfate1 in 1 CARTONSOLUTION19
0487-9501-03Albuterol Sulfate30 in 1 POUCHSOLUTION309
0487-9501-25Albuterol Sulfate1 in 1 CARTONSOLUTION19
0487-9501-25Albuterol Sulfate25 in 1 POUCHSOLUTION259
0487-9501-60Albuterol Sulfate30 in 1 POUCHSOLUTION309
0487-9501-60Albuterol Sulfate2 in 1 CARTONSOLUTION29

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0487-9501-01ML - Milliliter0487-9501637bb1de-e4ec-4ab4-93da-5b0a8c4af48812012-07-24
0487-9501-02ML - Milliliter0487-9501c7e81d26-15a2-483b-9d32-be58adb9084e12012-07-24
0487-9501-03ML - Milliliter0487-950148929ec7-83a2-4d17-ae80-b7e74d22874a12012-07-24
0487-9501-25ML - Milliliter0487-9501b2ce19d3-f0b8-495a-9ee5-f15b8886d55312012-07-24
0487-9501-60ML - Milliliter0487-950125e2619c-5774-4ce7-a8cd-cbed5d27bfb312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALBUTEROL SULFATEACTIVE INGREDIENT021SEF3731ALBUTEROL SULFATE SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]2
ALBUTEROL SULFATEACTIVE INGREDIENT021SEF3731ALBUTEROL SULFATE SOLUTION [REBEL DISTRIBUTORS CORP.]2
ALBUTEROLACTIVE MOIETYQF8SVZ843EALBUTEROL SULFATE SOLUTION [REBEL DISTRIBUTORS CORP.]2
ALBUTEROLACTIVE MOIETYQF8SVZ843EALBUTEROL SULFATE SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XALBUTEROL SULFATE SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XALBUTEROL SULFATE SOLUTION [REBEL DISTRIBUTORS CORP.]2
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFALBUTEROL SULFATE SOLUTION [REBEL DISTRIBUTORS CORP.]2
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFALBUTEROL SULFATE SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]2
WATERINACTIVE INGREDIENT059QF0KO0RALBUTEROL SULFATE SOLUTION [REBEL DISTRIBUTORS CORP.]2
WATERINACTIVE INGREDIENT059QF0KO0RALBUTEROL SULFATE SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]2
ALBUTEROL SULFATEACTIVE INGREDIENT021SEF3731ALBUTEROL SULFATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
ALBUTEROL SULFATEACTIVE INGREDIENT021SEF3731ALBUTEROL SULFATE SOLUTION [PROFICIENT RX LP]1
ALBUTEROLACTIVE MOIETYQF8SVZ843EALBUTEROL SULFATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
ALBUTEROLACTIVE MOIETYQF8SVZ843EALBUTEROL SULFATE SOLUTION [PROFICIENT RX LP]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XALBUTEROL SULFATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XALBUTEROL SULFATE SOLUTION [PROFICIENT RX LP]1
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFALBUTEROL SULFATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFALBUTEROL SULFATE SOLUTION [PROFICIENT RX LP]1
WATERINACTIVE INGREDIENT059QF0KO0RALBUTEROL SULFATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RALBUTEROL SULFATE SOLUTION [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0487-9501ALBUTEROL SULFATE SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]8Current NDC, Legacy NDC, 8 package rows20250411_574824f3-51cc-4b94-9c10-e3204d8b19f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
630208albuterol sulfate 0.083 % Inhalation SolutionPSN574824f3-51cc-4b94-9c10-e3204d8b19f89
630208albuterol 0.83 MG/ML Inhalation SolutionSCD574824f3-51cc-4b94-9c10-e3204d8b19f89
630208albuterol 0.083 % Inhalation SolutionSY574824f3-51cc-4b94-9c10-e3204d8b19f89
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSY574824f3-51cc-4b94-9c10-e3204d8b19f89
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSY574824f3-51cc-4b94-9c10-e3204d8b19f89
630208albuterol sulfate 0.083 % Inhalation SolutionPSN749992b4-69e0-0cc8-e053-2991aa0aeb256
630208albuterol 0.83 MG/ML Inhalation SolutionSCD749992b4-69e0-0cc8-e053-2991aa0aeb256
630208albuterol 0.083 % Inhalation SolutionSY749992b4-69e0-0cc8-e053-2991aa0aeb256
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSY749992b4-69e0-0cc8-e053-2991aa0aeb256
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSY749992b4-69e0-0cc8-e053-2991aa0aeb256
630208albuterol sulfate 0.083 % Inhalation SolutionPSN813d49be-3651-6759-e053-2991aa0a6a9f5
630208albuterol sulfate 0.083 % Inhalation SolutionPSNd3d2ab1e-8f91-4a4d-aa6b-5a57f59ad56b5
630208albuterol 0.83 MG/ML Inhalation SolutionSCD813d49be-3651-6759-e053-2991aa0a6a9f5
630208albuterol 0.83 MG/ML Inhalation SolutionSCDd3d2ab1e-8f91-4a4d-aa6b-5a57f59ad56b5
630208albuterol 0.083 % Inhalation SolutionSY813d49be-3651-6759-e053-2991aa0a6a9f5
630208albuterol 0.083 % Inhalation SolutionSYd3d2ab1e-8f91-4a4d-aa6b-5a57f59ad56b5
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSY813d49be-3651-6759-e053-2991aa0a6a9f5
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSYd3d2ab1e-8f91-4a4d-aa6b-5a57f59ad56b5
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSYd3d2ab1e-8f91-4a4d-aa6b-5a57f59ad56b5
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSY813d49be-3651-6759-e053-2991aa0a6a9f5
630208albuterol sulfate 0.083 % Inhalation SolutionPSN9d4ef83f-8ca0-811e-e053-2995a90a6d0d3
630208albuterol sulfate 0.083 % Inhalation SolutionPSN8f52f15f-3fb7-4b00-a19f-8721c5ac55db3
630208albuterol 0.83 MG/ML Inhalation SolutionSCD9d4ef83f-8ca0-811e-e053-2995a90a6d0d3
630208albuterol 0.83 MG/ML Inhalation SolutionSCD8f52f15f-3fb7-4b00-a19f-8721c5ac55db3
630208albuterol 0.083 % Inhalation SolutionSY9d4ef83f-8ca0-811e-e053-2995a90a6d0d3
630208albuterol 0.083 % Inhalation SolutionSY8f52f15f-3fb7-4b00-a19f-8721c5ac55db3
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSY8f52f15f-3fb7-4b00-a19f-8721c5ac55db3
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSY9d4ef83f-8ca0-811e-e053-2995a90a6d0d3
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSY9d4ef83f-8ca0-811e-e053-2995a90a6d0d3
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSY8f52f15f-3fb7-4b00-a19f-8721c5ac55db3
630208albuterol sulfate 0.083 % Inhalation SolutionPSN2e439746-9808-4102-a92f-bf6c3f1e35132
630208albuterol sulfate 0.083 % Inhalation SolutionPSNa33e20e0-3936-450d-a9d9-3ff51c6f26c52
630208albuterol sulfate 0.083 % Inhalation SolutionPSN17f5eea5-c6a3-914b-e063-6294a90a2e162
630208albuterol 0.83 MG/ML Inhalation SolutionSCD17f5eea5-c6a3-914b-e063-6294a90a2e162
630208albuterol 0.83 MG/ML Inhalation SolutionSCDa33e20e0-3936-450d-a9d9-3ff51c6f26c52
630208albuterol 0.83 MG/ML Inhalation SolutionSCD2e439746-9808-4102-a92f-bf6c3f1e35132
630208albuterol 0.083 % Inhalation SolutionSY17f5eea5-c6a3-914b-e063-6294a90a2e162
630208albuterol 0.083 % Inhalation SolutionSYa33e20e0-3936-450d-a9d9-3ff51c6f26c52
630208albuterol 0.083 % Inhalation SolutionSY2e439746-9808-4102-a92f-bf6c3f1e35132
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSY2e439746-9808-4102-a92f-bf6c3f1e35132
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSYa33e20e0-3936-450d-a9d9-3ff51c6f26c52
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSY17f5eea5-c6a3-914b-e063-6294a90a2e162
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSYa33e20e0-3936-450d-a9d9-3ff51c6f26c52
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSY17f5eea5-c6a3-914b-e063-6294a90a2e162
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSY2e439746-9808-4102-a92f-bf6c3f1e35132
630208albuterol sulfate 0.083 % Inhalation SolutionPSN8153d82c-b5c5-4aa2-bce5-b69cf2d23f5d1
630208albuterol sulfate 0.083 % Inhalation SolutionPSN8ea40065-4f59-434f-9ea1-7ef006fde66e1
630208albuterol sulfate 0.083 % Inhalation SolutionPSN056e145b-87aa-4009-a7ab-2ac0bd086eb01
630208albuterol sulfate 0.083 % Inhalation SolutionPSN2ec64742-5802-49f0-bbbe-95580730c0a71
630208albuterol 0.83 MG/ML Inhalation SolutionSCD8ea40065-4f59-434f-9ea1-7ef006fde66e1
630208albuterol 0.83 MG/ML Inhalation SolutionSCD056e145b-87aa-4009-a7ab-2ac0bd086eb01
630208albuterol 0.83 MG/ML Inhalation SolutionSCD2ec64742-5802-49f0-bbbe-95580730c0a71
630208albuterol 0.83 MG/ML Inhalation SolutionSCD8153d82c-b5c5-4aa2-bce5-b69cf2d23f5d1
630208albuterol 0.083 % Inhalation SolutionSY8ea40065-4f59-434f-9ea1-7ef006fde66e1
630208albuterol 0.083 % Inhalation SolutionSY8153d82c-b5c5-4aa2-bce5-b69cf2d23f5d1
630208albuterol 0.083 % Inhalation SolutionSY2ec64742-5802-49f0-bbbe-95580730c0a71
630208albuterol 0.083 % Inhalation SolutionSY056e145b-87aa-4009-a7ab-2ac0bd086eb01
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSY8ea40065-4f59-434f-9ea1-7ef006fde66e1
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSY8153d82c-b5c5-4aa2-bce5-b69cf2d23f5d1
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSY056e145b-87aa-4009-a7ab-2ac0bd086eb01
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSY2ec64742-5802-49f0-bbbe-95580730c0a71
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSY8ea40065-4f59-434f-9ea1-7ef006fde66e1
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSY8153d82c-b5c5-4aa2-bce5-b69cf2d23f5d1
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSY056e145b-87aa-4009-a7ab-2ac0bd086eb01
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSY2ec64742-5802-49f0-bbbe-95580730c0a71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0487-9501-010048795010130 POUCH in 1 CARTON (0487-9501-01) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE30 pouch1997-09-170000-00-00NoNoCurrent
0487-9501-03004879501031 POUCH in 1 CARTON (0487-9501-03) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE1 pouch1997-09-170000-00-00NoNoCurrent
0487-9501-25004879501251 POUCH in 1 CARTON (0487-9501-25) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE1 pouch1997-09-170000-00-00NoNoCurrent
0487-9501-60004879501602 POUCH in 1 CARTON (0487-9501-60) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE2 pouch1997-09-170000-00-00NoNoCurrent