Albuterol Sulfate
- Product NDC
- 68788-7702
- 11-digit product format
- 687887702
- Labeler code
- 68788
- Product ID
- 68788-7702_21ccea42-fab8-4674-8e14-d012f78494b7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Albuterol Sulfate
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA074880
- Marketing category
- ANDA
- Marketing start
- 2020-05-01
- Marketing end
- 0000-00-00
- Substance
- ALBUTEROL SULFATE
- Active strength
- 3 mg/3mL
- Pharmacologic classes
- Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 68788-7702 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 68788-7702 | 68788-7702-2 | D | Discontinued by firm | 2026-08-03 |
Orange Book products#
| 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#
| 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.
| 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#
| 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… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68788-7702-2 | ML - Milliliter | 68788-7702 | e626504f-36c2-43c1-b422-5a36b32440d6 | 1 | 2020-08-06 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68788-7702 | ALBUTEROL SULFATE SOLUTION [PREFERRED PHARMACEUTICALS, INC.] | 6 | Legacy NDC | 20250105_c0ea723f-a899-4cdc-99f5-1d43fe86afc8.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.
| 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 | 074880 ANDA074880 |
| Albuterol Sulfate | ALBUTEROL SULFATE | Sportpharm LLC | a33e20e0-3936-450d-a9d9-3ff51c6f26c5 | 2026-04-24 | Warnings, Adverse reactions | 074880 ANDA074880 |
| Albuterol Sulfate | ALBUTEROL SULFATE | Nephron Pharmaceuticals Corporation | 574824f3-51cc-4b94-9c10-e3204d8b19f8 | 2025-11-07 | Warnings, Adverse reactions | 074880 ANDA074880 |
| Albuterol Sulfate | ALBUTEROL SULFATE | ASCLEMED USA INC. | 8ea40065-4f59-434f-9ea1-7ef006fde66e | 2025-11-07 | Warnings, Adverse reactions | 074880 ANDA074880 |
| Albuterol Sulfate | ALBUTEROL SULFATE | Asclemed USA, Inc. | 056e145b-87aa-4009-a7ab-2ac0bd086eb0 | 2025-11-06 | Warnings, Adverse reactions | 074880 ANDA074880 |
| Albuterol Sulfate | ALBUTEROL SULFATE | NuCare Pharmaceuticals,Inc. | 813d49be-3651-6759-e053-2991aa0a6a9f | 2025-02-06 | Warnings, Adverse reactions | 074880 ANDA074880 |
| Albuterol Sulfate | ALBUTEROL SULFATE | NuCare Pharmaceuticals,Inc. | 749992b4-69e0-0cc8-e053-2991aa0aeb25 | 2025-01-08 | Warnings, Adverse reactions | 074880 ANDA074880 |
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | HF Acquisition Co LLC, DBA HealthFirst | 9d4ef83f-8ca0-811e-e053-2995a90a6d0d | 2025-01-08 | Warnings, Adverse reactions | 074880 ANDA074880 |
| Albuterol Sulfate | ALBUTEROL SULFATE | Chartwell RX, LLC | 922bf33b-4d55-4c35-9f68-72efbb17c14f | 2024-02-21 | Warnings, Adverse reactions | 074880 ANDA074880 |
| Albuterol Sulfate | ALBUTEROL SULFATE | A-S Medication Solutions | 8f52f15f-3fb7-4b00-a19f-8721c5ac55db | 2023-07-24 | Warnings, Adverse reactions | 074880 ANDA074880 |
| Albuterol Sulfate | ALBUTEROL SULFATE | Proficient Rx LP | d3d2ab1e-8f91-4a4d-aa6b-5a57f59ad56b | 2022-11-01 | Warnings, Adverse reactions | 074880 ANDA074880 |
| Albuterol Sulfate | ALBUTEROL SULFATE | Asclemed USA, Inc. | 8153d82c-b5c5-4aa2-bce5-b69cf2d23f5d | 2020-10-16 | Warnings, Adverse reactions | 074880 ANDA074880 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68788-7702-2 | 68788770202 | 1 POUCH in 1 CARTON (68788-7702-2) > 25 VIAL, SINGLE-DOSE in 1 POUCH > 3 mL in 1 VIAL, SINGLE-DOSE | 1 pouch | 2020-05-01 | 0000-00-00 | No | No | Current |