Albuterol Tablets, USP

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-11-25
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 21:18:12

Label at a glance#

ProductAlbuterol

Active ingredientALBUTEROL SULFATE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1511-1 in bottle of 100 tablets

Albuterol tablets USP, 2 mg

Rx only

100 Tablets

NDC 70771-1512-1 in bottle of 100 tablets

Albuterol tablets USP, 4 mg

Rx only

100 Tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
197316	albuterol 2 MG Oral Tablet	PSN	4
197318	albuterol 4 MG Oral Tablet	PSN	4
197316	albuterol 2 MG Oral Tablet	SCD	4
197318	albuterol 4 MG Oral Tablet	SCD	4
197316	albuterol 2 MG (as albuterol sulfate 2.4 MG) Oral Tablet	SY	4
197318	albuterol 4 MG (as albuterol sulfate 4.8 MG) Oral Tablet	SY	4

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
ALBUTEROL Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
26005090-31a1-441d-920b-db3101a55d53	Product name	3	20250221
1c39b897-7219-42a1-9f3a-ec86cfd7b04b	Product name	3	20250218
0a278166-c8aa-41b6-b4a5-6ac332bde76a	Product name	1	20230718
c76bcd0f-25eb-471e-b970-1956c95c26c5	Product name	1	20230425
36390b75-5438-47d3-af60-732a654e9025	Product name	2	20220110
387afa72-0c5a-0d6b-ee2c-60c3506659e8	Product name	6	20210518
1b8ea3ec-88bd-98ea-c961-00ae340b5b14	Product name	2	20200220
3aa5a017-61e9-0c89-adef-13e7964d22f0	Product name	3	20171208
c3c27a99-b8bc-4955-841c-26555f58ee7e	Product name	1	20150421
bc98cf6f-a973-7162-5e30-0e7dd8c56bc3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70771-1511-1	2024-07-02	C162847	48780-1	1030e364-fa38-111a-e063-dadaa90a10e2	Albuterol Tablets, USP
70771-1512-1	2024-07-02	C162847	48780-1	1030e364-fa38-111a-e063-dadaa90a10e2	Albuterol Tablets, USP
70771-1512-5	2024-07-02	C162847	48780-1	1030e364-fa38-111a-e063-dadaa90a10e2	Albuterol Tablets, USP
70771-1511-1	2024-01-30	C162847	48780-1	1030e364-fa38-111a-e063-dadaa90a10e2	Albuterol Tablets, USP
70771-1512-1	2024-01-30	C162847	48780-1	1030e364-fa38-111a-e063-dadaa90a10e2	Albuterol Tablets, USP
70771-1512-5	2024-01-30	C162847	48780-1	1030e364-fa38-111a-e063-dadaa90a10e2	Albuterol Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70771-1511-1	Albuterol	100 in 1 BOTTLE	TABLET	100	4
70771-1512-1	Albuterol	100 in 1 BOTTLE	TABLET	100	4
70771-1512-5	Albuterol	500 in 1 BOTTLE	TABLET	500	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
70771-1512	ALBUTEROL TABLET [ZYDUS LIFESCIENCES LIMITED]	4	Current NDC, Legacy NDC, 2 package rows	20241127_a4709eea-e4a2-46e2-850f-1e6afca01893.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Albuterol
ALBUTEROL SULFATE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE K30
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1511	70771-1511-1
70771-1512	70771-1512-1, 70771-1512-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALBUTEROL SULFATE	021SEF3731	ACTIM
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POVIDONE K30	U725QWY32X	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
STARCH, CORN	O8232NY3SJ	IACT
ALBUTEROL SULFATE	021SEF3731	ACTIM
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POVIDONE K30	U725QWY32X	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
STARCH, CORN	O8232NY3SJ	IACT

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-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.

Application-product, TE code table
Application-product	TE code
A208884-001	AB
A208884-002	AB

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 · 76 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
2026-09-14 22:38:34	2026-08	A208884-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB		2020-10-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208884-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	RS	2020-10-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208884-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB		2020-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208884-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	RS	2020-10-22	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A208884-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208884-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208884-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208884-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208884-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208884-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208884-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208884-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208884-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208884-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208884-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208884-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208884-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208884-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208884-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208884-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208884-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208884-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208884-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208884-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208884-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208884-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208884-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208884-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208884-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208884-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208884-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208884-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208884-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208884-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208884-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208884-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208884-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208884-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208884-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208884-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208884-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208884-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208884-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208884-002	AB	1	`bb7c543d1eb4…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Albuterol	ALBUTEROL	Zydus Lifesciences Limited	a4709eea-e4a2-46e2-850f-1e6afca01893	2024-11-25		Exact identifier ndc (package): 70771-1511-1 ndc (package): 70771-1512-1 ndc (package): 70771-1512-5 ndc (product): 70771-1511 ndc (product): 70771-1512 ndc11 (package): 70771151101 ndc11 (package): 70771151201 ndc11 (package): 70771151205 spl id: f4ea29a0-b1df-4ca8-9438-1f0300eb6d9d spl set id: a4709eea-e4a2-46e2-850f-1e6afca01893

Reported adverse events (FAERS/openFDA)#

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