Application 074880

Type: ANDA
Sponsor: NEPHRON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALBUTEROL SULFATE	ALBUTEROL SULFATE	SOLUTION;INHALATION	EQ 0.083% BASE	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A074880-001	ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074880-001	AN

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 · 41 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	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074880-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	RS	1997-09-17	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074880-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074880-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074880-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074880-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074880-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074880-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074880-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074880-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074880-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074880-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074880-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074880-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074880-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074880-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074880-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074880-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074880-001	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074880-001	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074880-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074880-001	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074880-001	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074880-001	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074880-001	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074880-001	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074880-001	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074880-001	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074880-001	AN	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074880-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074880-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074880-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074880-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074880-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074880-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074880-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074880-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074880-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074880-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074880-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074880-001	AN	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074880-001	AN	1	`cb3db0bc1861…`

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Albuterol Sulfate	ALBUTEROL SULFATE	Rising Pharma Holdings, Inc.	32377c09-da6d-331c-e063-6294a90a7a46	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074880 application number: ANDA074880
Albuterol Sulfate	ALBUTEROL SULFATE	Sportpharm LLC	a33e20e0-3936-450d-a9d9-3ff51c6f26c5	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074880 application number: ANDA074880
Albuterol Sulfate	ALBUTEROL SULFATE	Nephron Pharmaceuticals Corporation	574824f3-51cc-4b94-9c10-e3204d8b19f8	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074880 application number: ANDA074880 ndc (product): 0487-9501
Albuterol Sulfate	ALBUTEROL SULFATE	ASCLEMED USA INC.	8ea40065-4f59-434f-9ea1-7ef006fde66e	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074880 application number: ANDA074880
Albuterol Sulfate	ALBUTEROL SULFATE	Asclemed USA, Inc.	056e145b-87aa-4009-a7ab-2ac0bd086eb0	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074880 application number: ANDA074880 ndc (product): 76420-087
Albuterol Sulfate	ALBUTEROL SULFATE	NuCare Pharmaceuticals,Inc.	813d49be-3651-6759-e053-2991aa0a6a9f	2025-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074880 application number: ANDA074880 ndc (product): 68071-4754
Albuterol Sulfate	ALBUTEROL SULFATE	NuCare Pharmaceuticals,Inc.	749992b4-69e0-0cc8-e053-2991aa0aeb25	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074880 application number: ANDA074880 ndc (product): 68071-4543
ALBUTEROL SULFATE	ALBUTEROL SULFATE	HF Acquisition Co LLC, DBA HealthFirst	9d4ef83f-8ca0-811e-e053-2995a90a6d0d	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074880 application number: ANDA074880 ndc (product): 51662-1499
Albuterol Sulfate	ALBUTEROL SULFATE	Chartwell RX, LLC	922bf33b-4d55-4c35-9f68-72efbb17c14f	2024-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074880 application number: ANDA074880
Albuterol Sulfate	ALBUTEROL SULFATE	A-S Medication Solutions	8f52f15f-3fb7-4b00-a19f-8721c5ac55db	2023-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074880 application number: ANDA074880
Albuterol Sulfate	ALBUTEROL SULFATE	Proficient Rx LP	d3d2ab1e-8f91-4a4d-aa6b-5a57f59ad56b	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074880 application number: ANDA074880 ndc (product): 63187-204
Albuterol Sulfate	ALBUTEROL SULFATE	Asclemed USA, Inc.	8153d82c-b5c5-4aa2-bce5-b69cf2d23f5d	2020-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074880 application number: ANDA074880 ndc (product): 76420-087

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0487-9501	Albuterol Sulfate	Albuterol Sulfate	Nephron SC Inc.	ANDA	Current
0487-9501	Albuterol Sulfate	Albuterol Sulfate	Nephron Pharmaceuticals Corporation	ANDA	Current
21695-332	Albuterol Sulfate	Albuterol Sulfate	Rebel Distributors Corp.	ANDA	Current
51662-1499	ALBUTEROL SULFATE	ALBUTEROL SULFATE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1499	ALBUTEROL SULFATE	ALBUTEROL SULFATE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
55154-4359	Albuterol Sulfate	Albuterol Sulfate	Cardinal Health 107, LLC	ANDA	Current
55154-4359	Albuterol Sulfate	Albuterol Sulfate	Cardinal Health, Inc.	ANDA	Current
63187-204	Albuterol Sulfate	Albuterol Sulfate	Proficient Rx LP	ANDA	Current
63187-204	Albuterol Sulfate	Albuterol Sulfate	Proficient Rx LP	ANDA	Current
63187-204	Albuterol Sulfate	Albuterol Sulfate	Proficient Rx LP	ANDA	Current
63187-204	Albuterol Sulfate	Albuterol Sulfate	Proficient Rx LP	ANDA	Current
66267-746	Albuterol Sulfate	Albuterol Sulfate	Nucare Pharmaceuticals, Inc.	ANDA	Current
66267-746	Albuterol Sulfate	Albuterol Sulfate	Nucare Pharmaceuticals, Inc.	ANDA	Current
68071-4048	Albuterol Sulfate	Albuterol Sulfate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4048	Albuterol Sulfate	Albuterol Sulfate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4543	Albuterol Sulfate	Albuterol Sulfate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4543	Albuterol Sulfate	Albuterol Sulfate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4543	Albuterol Sulfate	Albuterol Sulfate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4754	Albuterol Sulfate	Albuterol Sulfate	NuCare Pharmaceuticals,In	ANDA	Current
68071-4754	Albuterol Sulfate	Albuterol Sulfate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4754	Albuterol Sulfate	Albuterol Sulfate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-0134	Albuterol Sulfate	Albuterol Sulfate	Preferred Pharmaceuticals, Inc	ANDA	Current
68788-7702	Albuterol Sulfate	Albuterol Sulfate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7702	Albuterol Sulfate	Albuterol Sulfate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7702	Albuterol Sulfate	Albuterol Sulfate	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-2413	Albuterol Sulfate	Albuterol Sulfate	REMEDYREPACK INC.	ANDA	Current
70518-2413	Albuterol Sulfate	Albuterol Sulfate	REMEDYREPACK INC.	ANDA	Current
70518-2413	Albuterol Sulfate	Albuterol Sulfate	REMEDYREPACK INC.	ANDA	Current
70518-2413	Albuterol Sulfate	Albuterol Sulfate	REMEDYREPACK INC.	ANDA	Current
70518-2613	Albuterol Sulfate	Albuterol Sulfate	REMEDYREPACK INC.	ANDA	Current
70518-2613	Albuterol Sulfate	Albuterol Sulfate	REMEDYREPACK INC.	ANDA	Current
70518-2613	Albuterol Sulfate	Albuterol Sulfate	REMEDYREPACK INC.	ANDA	Current
76420-087	Albuterol Sulfate	Albuterol Sulfate	Asclemed USA, Inc.	ANDA	Current