Home NDC 76204-027 Albuterol Sulfate Inhalation Solution, 0.5%
Product NDC 76204-027
11-digit product format 762040027
Labeler code 76204
Product ID 76204-027_4e7f86ab-55bc-c123-e063-6394a90abd8d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Albuterol Sulfate
Dosage form SOLUTION
Route RESPIRATORY (INHALATION)
Labeler Ritedose Pharmaceuticals, LLC
Application ANDA218386
Marketing category ANDA
Marketing start 2025-03-24
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218386-001 ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 0.5% BASE SOLUTION / INHALATION AN 2025-03-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218386-001 AN
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A218386-001 ALBUTEROL SULFATE EQ 0.5% BASE SOLUTION / INHALATION AN 2025-03-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218386-001 ALBUTEROL SULFATE EQ 0.5% BASE SOLUTION / INHALATION AN 2025-03-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218386-001 ALBUTEROL SULFATE EQ 0.5% BASE SOLUTION / INHALATION AN 2025-03-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218386-001 ALBUTEROL SULFATE EQ 0.5% BASE SOLUTION / INHALATION AN 2025-03-12 fd3edfee7708…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218386-001 ALBUTEROL SULFATE EQ 0.5% BASE SOLUTION / INHALATION AN 2025-03-12 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Albuterol Sulfate Inhalation Solution, 0.5%
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALBUTEROL SULFATE 2.5 mg/.5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 021SEF3731 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 245314 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76204-027-01 Albuterol Sulfate Inhalation Solution, 0.5% 30 in 1 CARTON SOLUTION 30 4 76204-027-11 Albuterol Sulfate Inhalation Solution, 0.5% 1 in 1 POUCH SOLUTION 1 4 76204-027-11 Albuterol Sulfate Inhalation Solution, 0.5% 0.5 mL in 1 VIAL SOLUTION 0.5 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76204-027 ALBUTEROL SULFATE INHALATION SOLUTION, 0.5% (ALBUTEROL SULFATE) SOLUTION [RITEDOSE PHARMACEUTICALS, LLC] 2 Current NDC, 3 package rows 20250326_fdb4ac5a-bf0d-4896-89f7-1828c081b79e.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 76204-027-01 76204002701 30 POUCH in 1 CARTON (76204-027-01) / 1 VIAL in 1 POUCH (76204-027-11) / .5 mL in 1 VIAL 30 pouch 2025-03-24 No No Current 76204-027-11 76204002711 1 in 1 POUCH Historical