ALBUTEROL SULFATE

Product NDC: 72162-2064
Requested package NDC: 72162-2064-2
11-digit product format: 721622064
Labeler code: 72162
Product ID: 72162-2064_04fd53e4-2877-4738-b62b-527b3770ba4c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ALBUTEROL SULFATE
Dosage form: SYRUP
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA212197
Marketing category: ANDA
Marketing start: 2019-09-06
Substance: ALBUTEROL SULFATE
Active strength: 2 mg/5mL
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 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212197-001	ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA		2019-09-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212197-001	AA

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A212197-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	2019-09-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212197-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	2019-09-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212197-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	2019-09-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212197-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	2019-09-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212197-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	2019-09-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212197-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	2019-09-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212197-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	2019-09-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212197-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	2019-09-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212197-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	2019-09-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212197-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	2019-09-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212197-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	2019-09-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212197-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	2019-09-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212197-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	2019-09-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212197-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	2019-09-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212197-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	2019-09-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212197-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	2019-09-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212197-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	2019-09-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212197-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	2019-09-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212197-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	2019-09-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212197-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	2019-09-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212197-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	2019-09-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212197-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	2019-09-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212197-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	2019-09-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212197-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	2019-09-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212197-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	2019-09-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212197-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	2019-09-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212197-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	2019-09-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A212197-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	2019-09-06	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212197-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	2019-09-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212197-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	2019-09-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212197-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	2019-09-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212197-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	2019-09-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212197-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	2019-09-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212197-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	2019-09-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212197-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	2019-09-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212197-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	2019-09-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212197-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	2019-09-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212197-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	2019-09-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212197-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	2019-09-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212197-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	2019-09-06	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A212197-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212197-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212197-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212197-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212197-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212197-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212197-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212197-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212197-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212197-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212197-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212197-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212197-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212197-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212197-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212197-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212197-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212197-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212197-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212197-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212197-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212197-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212197-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212197-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212197-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212197-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212197-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A212197-001	AA	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212197-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212197-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212197-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212197-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212197-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212197-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212197-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212197-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212197-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212197-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212197-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212197-001	AA	1	`e64feba35796…`

Reported adverse events (FAERS/openFDA)#

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

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/5mL

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
755497	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
45e07bdd-78f9-4055-9de3-646e67de7eaf	Available on FDA.report

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
36390b75-5438-47d3-af60-732a654e9025	Product name	2	20220110
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
387afa72-0c5a-0d6b-ee2c-60c3506659e8	Product name	6	20210518
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
1b8ea3ec-88bd-98ea-c961-00ae340b5b14	Product name	2	20200220
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
3aa5a017-61e9-0c89-adef-13e7964d22f0	Product name	3	20171208
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
c3c27a99-b8bc-4955-841c-26555f58ee7e	Product name	1	20150421
bc98cf6f-a973-7162-5e30-0e7dd8c56bc3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72162-2064-2	ALBUTEROL SULFATE	473 mL in 1 BOTTLE	SYRUP	473		101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72162-2064-2	ML - Milliliter	72162-2064	ac7027fd-34b7-4dea-8052-d176c9811d58	1	2023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72162-2064	ALBUTEROL SULFATE SYRUP [BRYANT RANCH PREPACK]	101	Current NDC, 1 package rows	20240816_45e07bdd-78f9-4055-9de3-646e67de7eaf.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ALBUTEROL SULFATE	ALBUTEROL SULFATE	Bryant Ranch Prepack	378461f2-7271-44a3-9da3-b39970b65d3a	2025-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212197 application number: ANDA212197
ALBUTEROL SULFATE	ALBUTEROL SULFATE	QUAGEN PHARMACEUTICALS LLC	99a490cc-e41d-436b-9cf3-8facb7ac714f	2025-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212197 application number: ANDA212197
ALBUTEROL SULFATE	ALBUTEROL SULFATE	Preferred Pharmaceuticals, Inc.	4aafc2dd-744d-4726-828f-70355aee6f70	2025-01-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212197 application number: ANDA212197
ALBUTEROL SULFATE	ALBUTEROL SULFATE	Bryant Ranch Prepack	45e07bdd-78f9-4055-9de3-646e67de7eaf	2024-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212197 application number: ANDA212197 ndc (package): 72162-2064-2 ndc (product): 72162-2064 ndc11 (package): 72162206402

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
021SEF3731	ALBUTEROL SULFATE	51022-70-9	ALBUTEROL SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
755497	albuterol sulfate 2 MG in 5 mL Oral Solution	PSN	45e07bdd-78f9-4055-9de3-646e67de7eaf	101
755497	albuterol 0.4 MG/ML Oral Solution	SCD	45e07bdd-78f9-4055-9de3-646e67de7eaf	101
755497	albuterol (as albuterol sulfate) 2 MG per 5 ML Syrup	SY	45e07bdd-78f9-4055-9de3-646e67de7eaf	101
755497	albuterol 2 MG per 5 ML Syrup	SY	45e07bdd-78f9-4055-9de3-646e67de7eaf	101

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72162-2064-2	72162206402	473 mL in 1 BOTTLE (72162-2064-2)	473 ml	2023-08-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Albuterol Sulfate Syrup, 2 mg/5 mL Rx only	Bryant Ranch Prepack	2024-08-15	HUMAN PRESCRIPTION DRUG LABEL	101