Home NDC 69238-1344 Albuterol
Product NDC 69238-1344
11-digit product format 692381344
Labeler code 69238
Product ID 69238-1344_efcb5cab-b9c0-4ef9-84fc-5f321c13a0ed
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Albuterol
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA208804
Marketing category ANDA
Marketing start 2018-05-24
Substance ALBUTEROL SULFATE
Active strength 2 mg/1
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208804-001 ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2018-05-21 A208804-002 ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 2018-05-21
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 A208804-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2018-05-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208804-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 2018-05-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208804-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2018-05-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208804-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 2018-05-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208804-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2018-05-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208804-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 2018-05-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208804-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2018-05-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208804-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 2018-05-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208804-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2018-05-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208804-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 2018-05-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208804-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2018-05-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208804-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 2018-05-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208804-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2018-05-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208804-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 2018-05-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208804-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2018-05-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208804-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 2018-05-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208804-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2018-05-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208804-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 2018-05-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208804-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2018-05-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208804-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 2018-05-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208804-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2018-05-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208804-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 2018-05-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208804-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2018-05-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208804-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 2018-05-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208804-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2018-05-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208804-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 2018-05-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208804-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2018-05-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A208804-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 2018-05-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208804-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2018-05-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208804-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 2018-05-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208804-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2018-05-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A208804-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 2018-05-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208804-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2018-05-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A208804-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 2018-05-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208804-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2018-05-21 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A208804-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 2018-05-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208804-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2018-05-21 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A208804-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 2018-05-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208804-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2018-05-21 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A208804-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 2018-05-21 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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALBUTEROL SULFATE 2 mg/1
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197316 Internal RxNorm lookup 197318 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 69238-1344-1 Albuterol 100 in 1 BOTTLE TABLET 100 7 69238-1344-5 Albuterol 500 in 1 BOTTLE TABLET 500 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69238-1344 ALBUTEROL TABLET [AMNEAL PHARMACEUTICALS NY LLC] 6 Current NDC, Legacy NDC, 2 package rows 20241220_230d66fc-f62c-42a6-adb3-0a0f879c8ad4.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 Marketing end Sample Exclude flag Status 69238-1344-1 69238134401 100 TABLET in 1 BOTTLE (69238-1344-1) 100 tablet 2018-05-24 No No Current 69238-1344-5 69238134405 500 TABLET in 1 BOTTLE (69238-1344-5) 500 tablet 2018-05-24 0000-00-00 No No Current