Albuterol Sulfate Inhalation Solution

Manufacturer
The Ritedose Corporation
Effective date
2022-12-22
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:43:38

Label at a glance#

ProductAlbuterol Sulfate Inhalation Solution
Active ingredientALBUTEROL SULFATE
Label structure4 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

NDC 76204-010-55

Albuterol Sulfate Inhalation Solution

0.63 mg* / 3 mL

*Each unit does vial contains 0.63 mg of albuterol equivalent to 0.75 mg albuterol sulfate.

For Inhalation Only

Sterile Unit-Dose Vials

Carton contains: 5 pouches of 5 x 3 mL vials each

RDP Albuterol Sulfate Inhalation Solution, 0.63 mg/3 mL, 25 Count Cards Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

25ct-cards-carton25ct-cards-carton

RDP Albuterol Sulfate Inhalation Solution, 0.63 mg/3 mL, 30 Count Singles Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30ct-singles-carton30ct-singles-carton

Mylan Albuterol Sulfate Inhalation Solution, 0.63 mg/3 mL, 25 Count Cards carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

viatris-25ct-cards-cartonviatris-25ct-cards-carton

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65302-06065302-060-01, 65302-060-05
65302-06465302-064-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214531-001ALBUTEROL SULFATEALBUTEROL SULFATEEQ 0.021% BASESOLUTION / INHALATIONANRS2021-12-28
A214531-002ALBUTEROL SULFATEALBUTEROL SULFATEEQ 0.042% BASESOLUTION / INHALATIONAN2021-12-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A214531-001AN
A214531-002AN

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 · 68 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A214531-001ALBUTEROL SULFATEEQ 0.021% BASESOLUTION / INHALATIONANRS2021-12-2884e616aacf4f…
2026-09-14 22:38:342026-08A214531-002ALBUTEROL SULFATEEQ 0.042% BASESOLUTION / INHALATIONAN2021-12-2884e616aacf4f…
2026-08-18 06:07:402026-07A214531-001ALBUTEROL SULFATEEQ 0.021% BASESOLUTION / INHALATIONANRS2021-12-28caaa826d4ba7…
2026-08-18 06:07:402026-07A214531-002ALBUTEROL SULFATEEQ 0.042% BASESOLUTION / INHALATIONAN2021-12-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214531-001ALBUTEROL SULFATEEQ 0.021% BASESOLUTION / INHALATIONANRS2021-12-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214531-002ALBUTEROL SULFATEEQ 0.042% BASESOLUTION / INHALATIONAN2021-12-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214531-001ALBUTEROL SULFATEEQ 0.021% BASESOLUTION / INHALATIONANRS2021-12-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214531-002ALBUTEROL SULFATEEQ 0.042% BASESOLUTION / INHALATIONAN2021-12-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A214531-001ALBUTEROL SULFATEEQ 0.021% BASESOLUTION / INHALATIONANRS2021-12-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214531-002ALBUTEROL SULFATEEQ 0.042% BASESOLUTION / INHALATIONAN2021-12-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214531-001ALBUTEROL SULFATEEQ 0.021% BASESOLUTION / INHALATIONANRS2021-12-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214531-002ALBUTEROL SULFATEEQ 0.042% BASESOLUTION / INHALATIONAN2021-12-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214531-001ALBUTEROL SULFATEEQ 0.021% BASESOLUTION / INHALATIONANRS2021-12-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214531-002ALBUTEROL SULFATEEQ 0.042% BASESOLUTION / INHALATIONAN2021-12-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214531-001ALBUTEROL SULFATEEQ 0.021% BASESOLUTION / INHALATIONANRS2021-12-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214531-002ALBUTEROL SULFATEEQ 0.042% BASESOLUTION / INHALATIONAN2021-12-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214531-001ALBUTEROL SULFATEEQ 0.021% BASESOLUTION / INHALATIONANRS2021-12-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214531-002ALBUTEROL SULFATEEQ 0.042% BASESOLUTION / INHALATIONAN2021-12-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214531-001ALBUTEROL SULFATEEQ 0.021% BASESOLUTION / INHALATIONANRS2021-12-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214531-002ALBUTEROL SULFATEEQ 0.042% BASESOLUTION / INHALATIONAN2021-12-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214531-001ALBUTEROL SULFATEEQ 0.021% BASESOLUTION / INHALATIONANRS2021-12-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214531-002ALBUTEROL SULFATEEQ 0.042% BASESOLUTION / INHALATIONAN2021-12-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214531-001ALBUTEROL SULFATEEQ 0.021% BASESOLUTION / INHALATIONANRS2021-12-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A214531-002ALBUTEROL SULFATEEQ 0.042% BASESOLUTION / INHALATIONAN2021-12-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214531-001ALBUTEROL SULFATEEQ 0.021% BASESOLUTION / INHALATIONANRS2021-12-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214531-002ALBUTEROL SULFATEEQ 0.042% BASESOLUTION / INHALATIONAN2021-12-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214531-001ALBUTEROL SULFATEEQ 0.021% BASESOLUTION / INHALATIONANRS2021-12-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214531-002ALBUTEROL SULFATEEQ 0.042% BASESOLUTION / INHALATIONAN2021-12-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214531-001ALBUTEROL SULFATEEQ 0.021% BASESOLUTION / INHALATIONANRS2021-12-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214531-002ALBUTEROL SULFATEEQ 0.042% BASESOLUTION / INHALATIONAN2021-12-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214531-001ALBUTEROL SULFATEEQ 0.021% BASESOLUTION / INHALATIONANRS2021-12-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A214531-002ALBUTEROL SULFATEEQ 0.042% BASESOLUTION / INHALATIONAN2021-12-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214531-001ALBUTEROL SULFATEEQ 0.021% BASESOLUTION / INHALATIONAN2021-12-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214531-002ALBUTEROL SULFATEEQ 0.042% BASESOLUTION / INHALATIONAN2021-12-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214531-001ALBUTEROL SULFATEEQ 0.021% BASESOLUTION / INHALATIONAN2021-12-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A214531-002ALBUTEROL SULFATEEQ 0.042% BASESOLUTION / INHALATIONAN2021-12-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214531-001ALBUTEROL SULFATEEQ 0.021% BASESOLUTION / INHALATIONAN2021-12-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A214531-002ALBUTEROL SULFATEEQ 0.042% BASESOLUTION / INHALATIONAN2021-12-284b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A214531-001ALBUTEROL SULFATEEQ 0.021% BASESOLUTION / INHALATIONAN2021-12-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A214531-002ALBUTEROL SULFATEEQ 0.042% BASESOLUTION / INHALATIONAN2021-12-28bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A214531-001AN184e616aacf4f…
2026-09-14 22:38:342026-08A214531-002AN184e616aacf4f…
2026-08-18 06:07:402026-07A214531-001AN1caaa826d4ba7…
2026-08-18 06:07:402026-07A214531-002AN1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214531-001AN1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214531-002AN1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214531-001AN131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214531-002AN131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214531-001AN16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214531-002AN16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214531-001AN1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214531-002AN1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214531-001AN1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214531-002AN1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214531-001AN103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214531-002AN103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214531-001AN12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214531-002AN12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214531-001AN15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214531-002AN15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214531-001AN1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214531-002AN1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214531-001AN1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214531-002AN1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214531-001AN179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214531-002AN179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214531-001AN1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214531-002AN1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214531-001AN11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214531-002AN11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214531-001AN18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A214531-002AN18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214531-001AN15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214531-002AN15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214531-001AN15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A214531-002AN15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214531-001AN14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A214531-002AN14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A214531-001AN1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A214531-002AN1bb7c543d1eb4…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f06cec73-d56c-eb04-e053-2a95a90a4d50f06cec73-d56b-eb04-e053-2a95a90a4d502022-12-22Exact identifier
spl id: f06cec73-d56c-eb04-e053-2a95a90a4d50
spl set id: f06cec73-d56b-eb04-e053-2a95a90a4d50

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.