Home NDC 64980-644 Albuterol Sulfate
Product NDC 64980-644
11-digit product format 649800644
Labeler code 64980
Product ID 64980-644_3301695d-8226-0f9b-e063-6394a90a9582
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Albuterol Sulfate
Dosage form SOLUTION
Route RESPIRATORY (INHALATION)
Labeler Rising Pharma Holdings, Inc
Application ANDA076355
Marketing category ANDA
Marketing start 2025-04-14
Substance ALBUTEROL SULFATE
Active strength 1.25 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076355-001 ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN RS 2004-06-28 A076355-002 ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN 2010-03-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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.
Product history page 1 of 3 · 82 observed 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 A076355-001 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN RS 2004-06-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076355-002 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN 2010-03-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076355-001 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN RS 2004-06-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076355-002 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN 2010-03-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076355-001 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN RS 2004-06-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076355-002 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN 2010-03-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076355-001 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN RS 2004-06-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076355-002 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN 2010-03-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076355-001 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN RS 2004-06-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076355-002 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN 2010-03-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076355-001 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN RS 2004-06-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076355-002 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN 2010-03-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076355-001 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN RS 2004-06-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076355-002 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN 2010-03-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076355-001 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN RS 2004-06-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076355-002 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN 2010-03-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076355-001 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN RS 2004-06-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076355-002 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN 2010-03-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076355-001 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN RS 2004-06-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076355-002 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN 2010-03-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076355-001 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN RS 2004-06-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076355-002 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN 2010-03-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076355-001 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN RS 2004-06-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076355-002 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN 2010-03-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076355-001 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN RS 2004-06-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076355-002 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN 2010-03-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076355-001 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN RS 2004-06-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A076355-002 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN 2010-03-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076355-001 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN 2004-06-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076355-002 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN 2010-03-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076355-001 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN 2004-06-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A076355-002 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN 2010-03-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076355-001 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN 2004-06-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A076355-002 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN 2010-03-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076355-001 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN 2004-06-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A076355-002 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN 2010-03-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076355-001 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN 2004-06-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A076355-002 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN 2010-03-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076355-001 ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION / INHALATION AN 2004-06-28 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A076355-002 ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION / INHALATION AN 2010-03-31 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Albuterol Sulfate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALBUTEROL SULFATE 1.25 mg/3mL
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 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 64980-644-02 Albuterol Sulfate 25 in 1 CARTON SOLUTION 25 2 64980-644-02 Albuterol Sulfate 1 in 1 POUCH SOLUTION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64980-644 ALBUTEROL SULFATE SOLUTION [RISING PHARMA HOLDINGS, INC] 2 Current NDC, 2 package rows 20250419_32474c0e-af35-69d1-e063-6394a90a53c6.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 · 3 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 64980-644-02 64980064402 25 POUCH in 1 CARTON (64980-644-02) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE 25 pouch 2025-04-30 No No Current