Home NDC 62135-671 Albuterol Sulfate
Product NDC 62135-671
11-digit product format 621350671
Labeler code 62135
Product ID 62135-671_fe7cbf82-9f32-327e-e053-6294a90aebc8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Albuterol Sulfate
Dosage form TABLET
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA072151
Marketing category ANDA
Marketing start 1989-12-05
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 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 A072151-001 ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 1989-12-05 A072151-002 ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL 1989-12-05
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 A072151-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 1989-12-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A072151-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL 1989-12-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072151-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 1989-12-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072151-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL 1989-12-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072151-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 1989-12-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A072151-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL 1989-12-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072151-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 1989-12-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072151-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL 1989-12-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072151-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 1989-12-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072151-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL 1989-12-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072151-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 1989-12-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072151-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL 1989-12-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072151-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 1989-12-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072151-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL 1989-12-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072151-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 1989-12-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072151-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL 1989-12-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072151-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 1989-12-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072151-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL 1989-12-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072151-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 1989-12-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A072151-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL 1989-12-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072151-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 1989-12-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072151-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL 1989-12-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072151-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 1989-12-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072151-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL 1989-12-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072151-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 1989-12-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072151-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL 1989-12-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072151-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 1989-12-05 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A072151-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL 1989-12-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072151-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 1989-12-05 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072151-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL 1989-12-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072151-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 1989-12-05 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A072151-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL 1989-12-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072151-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 1989-12-05 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A072151-002 ALBUTEROL SULFATE EQ 4MG BASE TABLET / ORAL 1989-12-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072151-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 1989-12-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072151-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 1989-12-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072151-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 1989-12-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072151-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 1989-12-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072151-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 1989-12-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072151-001 ALBUTEROL SULFATE EQ 2MG BASE TABLET / ORAL 1989-12-05 8869cabd3fbd…
Additional Listing Data#
Finished product Yes
Brand name base Albuterol Sulfate
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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62135-671-90 Albuterol Sulfate 90 in 1 BOTTLE TABLET 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-671 ALBUTEROL SULFATE TABLET [CHARTWELL RX, LLC] 1 Current NDC, 1 package rows 20230620_81cdae6f-99d7-468b-9ab8-fecb1d42298d.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 62135-671-90 62135067190 90 TABLET in 1 BOTTLE (62135-671-90) 90 tablet 2023-06-14 No No Current