Application 080205
- Type
- ANDA
- Sponsor
- HOSPIRA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | INJECTABLE;INJECTION | 2MEQ/ML | No | Yes |
| 003 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | INJECTABLE;INJECTION | 1MEQ/ML | No | No |
| 004 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | INJECTABLE;INJECTION | 2.4MEQ/ML | No | No |
| 005 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | INJECTABLE;INJECTION | 3.2MEQ/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A080205-001 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 2MEQ/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | |
| A080205-003 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 1MEQ/ML | INJECTABLE / INJECTION | Approved before 1982 | ||
| A080205-004 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 2.4MEQ/ML | INJECTABLE / INJECTION | Approved before 1982 | ||
| A080205-005 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 3.2MEQ/ML | INJECTABLE / INJECTION | Approved before 1982 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A080205-001 | AP |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A080205-001 | POTASSIUM CHLORIDE | 2MEQ/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A080205-003 | POTASSIUM CHLORIDE | 1MEQ/ML | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A080205-004 | POTASSIUM CHLORIDE | 2.4MEQ/ML | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A080205-005 | POTASSIUM CHLORIDE | 3.2MEQ/ML | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A080205-001 | POTASSIUM CHLORIDE | 2MEQ/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A080205-003 | POTASSIUM CHLORIDE | 1MEQ/ML | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A080205-004 | POTASSIUM CHLORIDE | 2.4MEQ/ML | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A080205-005 | POTASSIUM CHLORIDE | 3.2MEQ/ML | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A080205-001 | POTASSIUM CHLORIDE | 2MEQ/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A080205-003 | POTASSIUM CHLORIDE | 1MEQ/ML | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A080205-004 | POTASSIUM CHLORIDE | 2.4MEQ/ML | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A080205-005 | POTASSIUM CHLORIDE | 3.2MEQ/ML | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A080205-001 | POTASSIUM CHLORIDE | 2MEQ/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A080205-003 | POTASSIUM CHLORIDE | 1MEQ/ML | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A080205-004 | POTASSIUM CHLORIDE | 2.4MEQ/ML | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A080205-005 | POTASSIUM CHLORIDE | 3.2MEQ/ML | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A080205-001 | POTASSIUM CHLORIDE | 2MEQ/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A080205-003 | POTASSIUM CHLORIDE | 1MEQ/ML | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A080205-004 | POTASSIUM CHLORIDE | 2.4MEQ/ML | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A080205-005 | POTASSIUM CHLORIDE | 3.2MEQ/ML | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A080205-001 | POTASSIUM CHLORIDE | 2MEQ/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A080205-003 | POTASSIUM CHLORIDE | 1MEQ/ML | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A080205-004 | POTASSIUM CHLORIDE | 2.4MEQ/ML | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A080205-005 | POTASSIUM CHLORIDE | 3.2MEQ/ML | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A080205-001 | POTASSIUM CHLORIDE | 2MEQ/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A080205-003 | POTASSIUM CHLORIDE | 1MEQ/ML | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A080205-004 | POTASSIUM CHLORIDE | 2.4MEQ/ML | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A080205-005 | POTASSIUM CHLORIDE | 3.2MEQ/ML | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A080205-001 | POTASSIUM CHLORIDE | 2MEQ/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A080205-003 | POTASSIUM CHLORIDE | 1MEQ/ML | INJECTABLE / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A080205-004 | POTASSIUM CHLORIDE | 2.4MEQ/ML | INJECTABLE / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A080205-005 | POTASSIUM CHLORIDE | 3.2MEQ/ML | INJECTABLE / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A080205-001 | POTASSIUM CHLORIDE | 2MEQ/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A080205-003 | POTASSIUM CHLORIDE | 1MEQ/ML | INJECTABLE / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A080205-004 | POTASSIUM CHLORIDE | 2.4MEQ/ML | INJECTABLE / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A080205-005 | POTASSIUM CHLORIDE | 3.2MEQ/ML | INJECTABLE / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A080205-001 | POTASSIUM CHLORIDE | 2MEQ/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A080205-003 | POTASSIUM CHLORIDE | 1MEQ/ML | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A080205-004 | POTASSIUM CHLORIDE | 2.4MEQ/ML | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A080205-005 | POTASSIUM CHLORIDE | 3.2MEQ/ML | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-09-29 23:25 UTC | 2022-09 | A080205-001 | AP | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A080205-001 | AP | 1 | cb3db0bc1861… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A080205-001 | AP | 1 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Hospira, Inc. | 559a0a8c-a8fe-40a5-b196-21f9308780ab | 2026-07-01 | Warnings, Adverse reactions | 080205 ANDA080205 0409-6653 0409-6635 0409-6651 |
| Potassium Chloride | POTASSIUM CHLORIDE | Henry Schein, Inc. | 8367a2ae-dfd9-4515-838c-529920291ca0 | 2025-11-07 | Warnings, Adverse reactions | 080205 ANDA080205 0404-9937 |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 9508355e-e1ed-412b-e053-2a95a90aac8e | 2025-01-08 | Warnings, Adverse reactions | 080205 ANDA080205 51662-1387 |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 951ffdc3-d54f-d5e1-e053-2a95a90a79e6 | 2025-01-08 | Warnings, Adverse reactions | 080205 ANDA080205 51662-1421 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0404-9937 | Potassium Chloride | Potassium Chloride | Henry Schein, Inc. | ANDA | Current |
| 0404-9937 | Potassium Chloride | Potassium Chloride | Henry Schein, Inc. | ANDA | Current |
| 0409-6635 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Hospira, Inc. | ANDA | Current |
| 0409-6635 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Hospira, Inc. | ANDA | Current |
| 0409-6635 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Hospira, Inc. | ANDA | Current |
| 0409-6635 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Hospira, Inc. | ANDA | Current |
| 0409-6651 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Hospira, Inc. | ANDA | Current |
| 0409-6651 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Hospira, Inc. | ANDA | Current |
| 0409-6651 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Hospira, Inc. | ANDA | Current |
| 0409-6651 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Hospira, Inc. | ANDA | Current |
| 0409-6653 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Hospira, Inc. | ANDA | Current |
| 0409-6653 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Hospira, Inc. | ANDA | Current |
| 0409-6653 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Hospira, Inc. | ANDA | Current |
| 0409-6653 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Hospira, Inc. | ANDA | Current |
| 51662-1387 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1387 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1421 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1421 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 52584-651 | Potassium Chloride | Potassium Chloride | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-651 | Potassium Chloride | Potassium Chloride | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-651 | Potassium Chloride | Potassium Chloride | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-651 | Potassium Chloride | Potassium Chloride | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-651 | Potassium Chloride | Potassium Chloride | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-653 | Potassium Chloride | Potassium Chloride | General Injectables & Vaccines, Inc | ANDA | Current |
| 52584-653 | Potassium Chloride | Potassium Chloride | General Injectables & Vaccines, Inc | ANDA | Current |
| 52584-653 | Potassium Chloride | Potassium Chloride | General Injectables & Vaccines, Inc | ANDA | Current |
| 55154-2367 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Cardinal Health | ANDA | Current |
| 55154-6999 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Cardinal Health | ANDA | Current |