SPL UNCLASSIFIED SECTION
Tobramycin Inhalation solution, for oral inhalation use
Tobramycin Inhalation solution, for oral inhalation use
- Manufacturer
- Holopack Verpackungstechnik GmbH
- Effective date
- 2021-08-26
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:37:03
Label at a glance#
ProductTobramycin
Active ingredientTOBRAMYCIN
Label structure2 sections
Label contents#
Full prescribing information#
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Tobramycin Inhalation Solution,
USP 300 mg/5 mL
NDC Code ASCEND: 67877-678-70
NDC Code Holopack: 60940-027-01
Store in a refrigerator at 2° to 8°C (36° to 46°F).
Mfd. By:
Holopack Verpackungstechnik GmbH
Bahnhofstr., 74429 Sulzbach-Laufen
Germany
Holopack Material No.: 011-01568
EXP 06/2024 Lot EXAMPLE02 QTY16
(17) 240630(10)EXAMPLE02(30)16
(01)50367877678707(21)0123456789AB
Products#
Every source-derived product name is available through these pages.
- Tobramycin
- SODIUM CHLORIDE
- SODIUM HYDROXIDE
- SULFURIC ACID
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 60940-027 | 60940-027-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| SULFURIC ACID | O40UQP6WCF | IACT |
| WATER | 059QF0KO0R | IACT |
| TOBRAMYCIN | VZ8RRZ51VK | ACTIB |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A212848-001 | TOBRAMYCIN | TOBRAMYCIN | 300MG/5ML | SOLUTION / INHALATION | AN | 2021-04-01 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A212848-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A212848-001 | TOBRAMYCIN | 300MG/5ML | SOLUTION / INHALATION | AN | 2021-04-01 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A212848-001 | TOBRAMYCIN | 300MG/5ML | SOLUTION / INHALATION | AN | 2021-04-01 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212848-001 | TOBRAMYCIN | 300MG/5ML | SOLUTION / INHALATION | AN | 2021-04-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212848-001 | TOBRAMYCIN | 300MG/5ML | SOLUTION / INHALATION | AN | 2021-04-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212848-001 | TOBRAMYCIN | 300MG/5ML | SOLUTION / INHALATION | AN | 2021-04-01 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212848-001 | TOBRAMYCIN | 300MG/5ML | SOLUTION / INHALATION | AN | 2021-04-01 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212848-001 | TOBRAMYCIN | 300MG/5ML | SOLUTION / INHALATION | AN | 2021-04-01 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212848-001 | TOBRAMYCIN | 300MG/5ML | SOLUTION / INHALATION | AN | 2021-04-01 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212848-001 | TOBRAMYCIN | 300MG/5ML | SOLUTION / INHALATION | AN | 2021-04-01 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212848-001 | TOBRAMYCIN | 300MG/5ML | SOLUTION / INHALATION | AN | 2021-04-01 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212848-001 | TOBRAMYCIN | 300MG/5ML | SOLUTION / INHALATION | AN | 2021-04-01 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A212848-001 | TOBRAMYCIN | 300MG/5ML | SOLUTION / INHALATION | AN | 2021-04-01 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212848-001 | TOBRAMYCIN | 300MG/5ML | SOLUTION / INHALATION | AN | 2021-04-01 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212848-001 | TOBRAMYCIN | 300MG/5ML | SOLUTION / INHALATION | AN | 2021-04-01 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212848-001 | TOBRAMYCIN | 300MG/5ML | SOLUTION / INHALATION | AN | 2021-04-01 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A212848-001 | TOBRAMYCIN | 300MG/5ML | SOLUTION / INHALATION | AN | 2021-04-01 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212848-001 | TOBRAMYCIN | 300MG/5ML | SOLUTION / INHALATION | AN | 2021-04-01 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A212848-001 | TOBRAMYCIN | 300MG/5ML | SOLUTION / INHALATION | AN | 2021-04-01 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A212848-001 | TOBRAMYCIN | 300MG/5ML | SOLUTION / INHALATION | AN | 2021-04-01 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | A212848-001 | TOBRAMYCIN | 300MG/5ML | SOLUTION / INHALATION | AN | 2021-04-01 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A212848-001 | TOBRAMYCIN | 300MG/5ML | SOLUTION / INHALATION | AN | 2021-04-01 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A212848-001 | TOBRAMYCIN | 300MG/5ML | SOLUTION / INHALATION | AN | 2021-04-01 | 87673890dc5c… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A212848-001 | TOBRAMYCIN | 300MG/5ML | SOLUTION / INHALATION | AN | 2021-04-01 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A212848-001 | TOBRAMYCIN | 300MG/5ML | SOLUTION / INHALATION | AN | 2021-04-01 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A212848-001 | TOBRAMYCIN | 300MG/5ML | SOLUTION / INHALATION | AN | 2021-04-01 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A212848-001 | TOBRAMYCIN | 300MG/5ML | SOLUTION / INHALATION | AN | 2021-04-01 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A212848-001 | TOBRAMYCIN | 300MG/5ML | SOLUTION / INHALATION | AN | 2021-04-01 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A212848-001 | TOBRAMYCIN | 300MG/5ML | SOLUTION / INHALATION | AN | 2021-04-01 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A212848-001 | TOBRAMYCIN | 300MG/5ML | SOLUTION / INHALATION | AN | 2021-04-01 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A212848-001 | TOBRAMYCIN | 300MG/5ML | SOLUTION / INHALATION | AN | 2021-04-01 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A212848-001 | TOBRAMYCIN | 300MG/5ML | SOLUTION / INHALATION | AN | 2021-04-01 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A212848-001 | TOBRAMYCIN | 300MG/5ML | SOLUTION / INHALATION | AN | 2021-04-01 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A212848-001 | TOBRAMYCIN | 300MG/5ML | SOLUTION / INHALATION | AN | 2021-04-01 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A212848-001 | TOBRAMYCIN | 300MG/5ML | SOLUTION / INHALATION | AN | 2021-04-01 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A212848-001 | TOBRAMYCIN | 300MG/5ML | SOLUTION / INHALATION | AN | 2021-04-01 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212848-001 | TOBRAMYCIN | 300MG/5ML | SOLUTION / INHALATION | AN | 2021-04-01 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A212848-001 | AN | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A212848-001 | AN | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A212848-001 | AN | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212848-001 | AN | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A212848-001 | AN | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212848-001 | AN | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212848-001 | AN | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212848-001 | AN | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212848-001 | AN | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212848-001 | AN | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212848-001 | AN | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A212848-001 | AN | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212848-001 | AN | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212848-001 | AN | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212848-001 | AN | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A212848-001 | AN | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212848-001 | AN | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A212848-001 | AN | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A212848-001 | AN | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A212848-001 | AN | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A212848-001 | AN | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A212848-001 | AN | 1 | 87673890dc5c… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A212848-001 | AN | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A212848-001 | AN | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A212848-001 | AN | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A212848-001 | AN | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A212848-001 | AN | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A212848-001 | AN | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A212848-001 | AN | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A212848-001 | AN | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A212848-001 | AN | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A212848-001 | AN | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A212848-001 | AN | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A212848-001 | AN | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A212848-001 | AN | 1 | cb3db0bc1861… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212848-001 | AN | 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 |
|---|---|---|---|---|---|---|
| ca7de493-36d2-0934-e053-2995a90a95ab | ca7de493-36d1-0934-e053-2995a90a95ab | 2021-08-26 | ca7de493-36d2-0934-e053-2995a90a95ab ca7de493-36d1-0934-e053-2995a90a95ab |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.