Home NDC 70771-1511 Albuterol
Product NDC 70771-1511
11-digit product format 707711511
Labeler code 70771
Product ID 70771-1511_f4ea29a0-b1df-4ca8-9438-1f0300eb6d9d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Albuterol
Dosage form TABLET
Route ORAL
Labeler Zydus Lifesciences Limited
Application ANDA208884
Marketing category ANDA
Marketing start 2020-10-23
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 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 70771-1511-1 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 70771-1511-1 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 70771-1511-1 1332a3947898…d4bfe170f9cd…
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 A208884-001 ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2020-10-22 A208884-002 ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB RS 2020-10-22
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 2 · 72 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 A208884-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2020-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208884-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 2020-10-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208884-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2020-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208884-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 2020-10-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208884-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2020-10-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208884-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 2020-10-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208884-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2020-10-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208884-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 2020-10-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208884-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2020-10-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208884-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 2020-10-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208884-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2020-10-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208884-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 2020-10-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208884-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2020-10-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208884-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 2020-10-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208884-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2020-10-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208884-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 2020-10-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208884-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2020-10-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208884-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 2020-10-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208884-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2020-10-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208884-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 2020-10-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208884-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2020-10-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208884-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 2020-10-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208884-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2020-10-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208884-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 2020-10-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208884-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2020-10-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208884-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 2020-10-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208884-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2020-10-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A208884-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 2020-10-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208884-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2020-10-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208884-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 2020-10-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208884-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2020-10-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A208884-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 2020-10-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208884-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2020-10-22 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A208884-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 2020-10-22 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A208884-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2020-10-22 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A208884-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 2020-10-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208884-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2020-10-22 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A208884-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 2020-10-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208884-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL AB 2020-10-22 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208884-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL AB 2020-10-22 87673890dc5c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 72 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Albuterol
Listing expiration 2026-12-31 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70771-1511-1 Albuterol 100 in 1 BOTTLE TABLET 100 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70771-1511 ALBUTEROL TABLET [ZYDUS LIFESCIENCES LIMITED] 4 Current NDC, Legacy NDC, 1 package rows 20241127_a4709eea-e4a2-46e2-850f-1e6afca01893.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 · 2 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 70771-1511-1 70771151101 100 TABLET in 1 BOTTLE (70771-1511-1) 100 tablet 2020-10-23 0000-00-00 No No Current