Levalbuterol tartrate HFA inhalation
- Product NDC
- 59368-410
- 11-digit product format
- 593680410
- Labeler code
- 59368
- Product ID
- 59368-410_37c9bb3a-2206-194d-e063-6394a90a145c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levalbuterol tartrate
- Dosage form
- AEROSOL, METERED
- Route
- ORAL
- Labeler
- Praxis, LLC
- Application
- NDA021730
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2016-10-03
- Substance
- LEVALBUTEROL TARTRATE
- Active strength
- 45 ug/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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021730-001 | XOPENEX HFA | LEVALBUTEROL TARTRATE | EQ 0.045MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2005-03-11 |
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.
| 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 | N021730-001 | XOPENEX HFA | EQ 0.045MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2005-03-11 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021730-001 | XOPENEX HFA | EQ 0.045MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2005-03-11 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021730-001 | XOPENEX HFA | EQ 0.045MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2005-03-11 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021730-001 | XOPENEX HFA | EQ 0.045MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2005-03-11 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021730-001 | XOPENEX HFA | EQ 0.045MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2005-03-11 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021730-001 | XOPENEX HFA | EQ 0.045MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2005-03-11 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021730-001 | XOPENEX HFA | EQ 0.045MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2005-03-11 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021730-001 | XOPENEX HFA | EQ 0.045MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2005-03-11 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021730-001 | XOPENEX HFA | EQ 0.045MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2005-03-11 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021730-001 | XOPENEX HFA | EQ 0.045MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2005-03-11 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021730-001 | XOPENEX HFA | EQ 0.045MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2005-03-11 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021730-001 | XOPENEX HFA | EQ 0.045MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2005-03-11 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021730-001 | XOPENEX HFA | EQ 0.045MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2005-03-11 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021730-001 | XOPENEX HFA | EQ 0.045MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2005-03-11 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021730-001 | XOPENEX HFA | EQ 0.045MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2005-03-11 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021730-001 | XOPENEX HFA | EQ 0.045MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2005-03-11 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021730-001 | XOPENEX HFA | EQ 0.045MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2005-03-11 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021730-001 | XOPENEX HFA | EQ 0.045MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2005-03-11 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N021730-001 | XOPENEX HFA | EQ 0.045MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2005-03-11 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N021730-001 | XOPENEX HFA | EQ 0.045MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2005-03-11 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021730-001 | XOPENEX HFA | EQ 0.045MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2005-03-11 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N021730-001 | XOPENEX HFA | EQ 0.045MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2005-03-11 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N021730-001 | XOPENEX HFA | EQ 0.045MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2005-03-11 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N021730-001 | XOPENEX HFA | EQ 0.045MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2005-03-11 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021730-001 | XOPENEX HFA | EQ 0.045MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2005-03-11 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021730-001 | XOPENEX HFA | EQ 0.045MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2005-03-11 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N021730-001 | XOPENEX HFA | EQ 0.045MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2005-03-11 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021730-001 | XOPENEX HFA | EQ 0.045MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2005-03-11 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N021730-001 | XOPENEX HFA | EQ 0.045MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2005-03-11 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N021730-001 | XOPENEX HFA | EQ 0.045MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2005-03-11 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021730-001 | XOPENEX HFA | EQ 0.045MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2005-03-11 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021730-001 | XOPENEX HFA | EQ 0.045MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2005-03-11 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021730-001 | XOPENEX HFA | EQ 0.045MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2005-03-11 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021730-001 | XOPENEX HFA | EQ 0.045MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2005-03-11 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N021730-001 | XOPENEX HFA | EQ 0.045MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2005-03-11 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N021730-001 | XOPENEX HFA | EQ 0.045MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2005-03-11 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021730-001 | XOPENEX HFA | EQ 0.045MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2005-03-11 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N021730-001 | XOPENEX HFA | EQ 0.045MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2005-03-11 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N021730-001 | XOPENEX HFA | EQ 0.045MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2005-03-11 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N021730-001 | XOPENEX HFA | EQ 0.045MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2005-03-11 | cb3db0bc1861… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021730-001 | 7256310 | 2024-10-08 | U-636 | Drug substance, Drug product | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021730-001 | 7256310 | 2024-10-08 | U-636 | Drug substance, Drug product | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021730-001 | 7256310 | 2024-10-08 | U-636 | Drug substance, Drug product | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021730-001 | 7256310 | 2024-10-08 | U-636 | Drug substance, Drug product | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021730-001 | 7256310 | 2024-10-08 | U-636 | Drug substance, Drug product | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021730-001 | 7256310 | 2024-10-08 | U-636 | Drug substance, Drug product | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021730-001 | 7256310 | 2024-10-08 | U-636 | Drug substance, Drug product | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021730-001 | 7256310 | 2024-10-08 | U-636 | Drug substance, Drug product | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021730-001 | 7256310 | 2024-10-08 | U-636 | Drug substance, Drug product | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021730-001 | 8765153 | 2023-12-08 | Drug product | 2014-07-28 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021730-001 | 7256310 | 2024-10-08 | U-636 | Drug substance, Drug product | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021730-001 | 8765153 | 2023-12-08 | Drug product | 2014-07-28 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021730-001 | 7256310 | 2024-10-08 | U-636 | Drug substance, Drug product | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021730-001 | 8765153 | 2023-12-08 | Drug product | 2014-07-28 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021730-001 | 7256310 | 2024-10-08 | U-636 | Drug substance, Drug product | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021730-001 | 8765153 | 2023-12-08 | Drug product | 2014-07-28 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021730-001 | 7256310 | 2024-10-08 | U-636 | Drug substance, Drug product | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N021730-001 | 8765153 | 2023-12-08 | Drug product | 2014-07-28 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N021730-001 | 7256310 | 2024-10-08 | U-636 | Drug substance, Drug product | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N021730-001 | 8765153 | 2023-12-08 | Drug product | 2014-07-28 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N021730-001 | 7256310 | 2024-10-08 | U-636 | Drug substance, Drug product | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021730-001 | 8765153 | 2023-12-08 | Drug product | 2014-07-28 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021730-001 | 7256310 | 2024-10-08 | U-636 | Drug substance, Drug product | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N021730-001 | 8765153 | 2023-12-08 | Drug product | 2014-07-28 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | N021730-001 | 7256310 | 2024-10-08 | U-636 | Drug substance, Drug product | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N021730-001 | 8765153 | 2023-12-08 | Drug product | 2014-07-28 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N021730-001 | 7256310 | 2024-10-08 | U-636 | Drug substance, Drug product | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N021730-001 | 8765153 | 2023-12-08 | Drug product | 2014-07-28 | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | N021730-001 | 7256310 | 2024-10-08 | U-636 | Drug substance, Drug product | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021730-001 | 8765153 | 2023-12-08 | Drug product | 2014-07-28 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021730-001 | 7256310 | 2024-10-08 | U-636 | Drug substance, Drug product | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021730-001 | 8765153 | 2023-12-08 | Drug product | 2014-07-28 | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021730-001 | 7256310 | 2024-10-08 | U-636 | Drug substance, Drug product | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N021730-001 | 8765153 | 2023-12-08 | Drug product | 2014-07-28 | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N021730-001 | 7256310 | 2024-10-08 | U-636 | Drug substance, Drug product | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021730-001 | 7256310 | 2024-10-08 | U-636 | Drug substance, Drug product | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N021730-001 | 7256310 | 2024-10-08 | U-636 | Drug substance, Drug product | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N021730-001 | 8765153 | 2023-12-08 | Drug product | 2014-07-28 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | N021730-001 | 7256310 | 2024-10-08 | U-636 | Drug substance, Drug product | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021730-001 | 8765153 | 2023-12-08 | Drug product | 2014-07-28 | a72a2bbeb626… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 3b93cc5d-8105-47d8-8ae6-077d0f655880 | Product name | 3 | 20190213 |
| 415a13b7-458d-4b44-ab20-f56d8ef7ab9d | Product name | 2 | 20170426 |
| a511b237-73ca-80ef-2a42-a935d09028ad | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59368-410-01 | Levalbuterol tartrate HFA inhalation | 1 in 1 CARTON | AEROSOL, METERED | 1 | 1 | |
| 59368-410-01 | Levalbuterol tartrate HFA inhalation | 200 in 1 INHALER | AEROSOL, METERED | 200 | 1 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| XOPENEX HFA | LEVALBUTEROL TARTRATE | Lupin Pharmaceuticals, Inc. | 70a35706-d7a8-4a48-98c6-1cab1c42fe8d | 2025-06-02 | Warnings, Adverse reactions | 021730 NDA021730 |
| Levalbuterol tartrate HFA inhalation | LEVALBUTEROL TARTRATE | Actavis Pharma, Inc. | ac85703a-17a2-4f0b-87f4-78f1756d2f85 | 2023-07-01 | Warnings, Adverse reactions | 021730 NDA021730 |
| Levalbuterol tartrate HFA inhalation | LEVALBUTEROL TARTRATE | Proficient Rx LP | a469689a-e64e-4117-b94a-c8b730abda1a | 2022-12-01 | Warnings, Adverse reactions | 021730 NDA021730 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 59368-410-01 | 59368041001 | 1 INHALER in 1 CARTON (59368-410-01) / 200 AEROSOL, METERED in 1 INHALER | 1 inhaler | 2016-10-03 | No | No | Historical |