Gadobutrol
- Product NDC
- 65219-281
- 11-digit product format
- 652190281
- Labeler code
- 65219
- Product ID
- 65219-281_490c8c3e-3195-40af-8f34-40d8df2719c3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gadobutrol
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA215061
- Marketing category
- ANDA
- Marketing start
- 2023-04-14
- Substance
- GADOBUTROL
- Active strength
- 604.72 mg/mL
- Pharmacologic classes
- Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215061-001 | GADOBUTROL | 1.20944GM/2ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215061-002 | GADOBUTROL | 4.5354GM/7.5ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215061-003 | GADOBUTROL | 6.0472GM/10ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215061-004 | GADOBUTROL | 9.0708GM/15ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215061-001 | GADOBUTROL | 1.20944GM/2ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215061-002 | GADOBUTROL | 4.5354GM/7.5ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215061-003 | GADOBUTROL | 6.0472GM/10ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215061-004 | GADOBUTROL | 9.0708GM/15ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A215061-001 | GADOBUTROL | 1.20944GM/2ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A215061-002 | GADOBUTROL | 4.5354GM/7.5ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A215061-003 | GADOBUTROL | 6.0472GM/10ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A215061-004 | GADOBUTROL | 9.0708GM/15ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 8072bd15b7f6… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215061-001 | GADOBUTROL | 1.20944GM/2ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215061-002 | GADOBUTROL | 4.5354GM/7.5ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215061-003 | GADOBUTROL | 6.0472GM/10ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215061-004 | GADOBUTROL | 9.0708GM/15ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A215061-001 | GADOBUTROL | 1.20944GM/2ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | A215061-002 | GADOBUTROL | 4.5354GM/7.5ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | A215061-003 | GADOBUTROL | 6.0472GM/10ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | A215061-004 | GADOBUTROL | 9.0708GM/15ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A215061-001 | GADOBUTROL | 1.20944GM/2ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | A215061-002 | GADOBUTROL | 4.5354GM/7.5ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | A215061-003 | GADOBUTROL | 6.0472GM/10ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | A215061-004 | GADOBUTROL | 9.0708GM/15ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215061-001 | GADOBUTROL | 1.20944GM/2ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215061-002 | GADOBUTROL | 4.5354GM/7.5ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215061-003 | GADOBUTROL | 6.0472GM/10ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215061-004 | GADOBUTROL | 9.0708GM/15ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A215061-001 | GADOBUTROL | 1.20944GM/2ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A215061-002 | GADOBUTROL | 4.5354GM/7.5ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A215061-003 | GADOBUTROL | 6.0472GM/10ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A215061-004 | GADOBUTROL | 9.0708GM/15ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A215061-001 | GADOBUTROL | 1.20944GM/2ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A215061-002 | GADOBUTROL | 4.5354GM/7.5ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A215061-003 | GADOBUTROL | 6.0472GM/10ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A215061-004 | GADOBUTROL | 9.0708GM/15ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A215061-001 | GADOBUTROL | 1.20944GM/2ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 3f0d92c62455… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A215061-002 | GADOBUTROL | 4.5354GM/7.5ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 3f0d92c62455… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A215061-003 | GADOBUTROL | 6.0472GM/10ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 3f0d92c62455… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A215061-004 | GADOBUTROL | 9.0708GM/15ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 3f0d92c62455… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215061-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215061-002 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215061-003 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215061-004 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215061-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215061-002 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215061-003 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215061-004 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A215061-001 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A215061-002 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A215061-003 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A215061-004 | AP | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215061-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215061-002 | AP | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215061-003 | AP | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215061-004 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A215061-001 | AP | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A215061-002 | AP | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A215061-003 | AP | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A215061-004 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A215061-001 | AP | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A215061-002 | AP | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A215061-003 | AP | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A215061-004 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215061-001 | AP | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215061-002 | AP | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215061-003 | AP | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215061-004 | AP | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A215061-001 | AP | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A215061-002 | AP | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A215061-003 | AP | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A215061-004 | AP | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A215061-001 | AP | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A215061-002 | AP | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A215061-003 | AP | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A215061-004 | AP | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A215061-001 | AP | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A215061-002 | AP | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A215061-003 | AP | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A215061-004 | AP | 1 | 3f0d92c62455… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Gadobutrol
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| GADOBUTROL | 604.72 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1BJ477IO2L | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 007696d0-4b62-4937-9640-4ad619504df4 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 77dc03a4-fbfc-e6a3-fe95-285bbae40d75 | Product name | 2 | 20250814 |
| 5b2d15dc-225b-aca9-f9ef-b38666fe1e57 | Product name | 4 | 20250620 |
| c34d3757-8380-f2a9-d77b-04fccc1c986e | Product name | 4 | 20250226 |
| 3c386306-c48a-413e-bb69-70cb268496f3 | Product name | 1 | 20210727 |
| 3c495eba-e7eb-cf97-a376-25ae31b0cc54 | Product name | 1 | 20140508 |
| 51162ac0-9a99-d9a1-b417-523615d04171 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65219-281-00 | Gadobutrol | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 2 | 3 | |
| 65219-281-02 | Gadobutrol | 3 in 1 CARTON | INJECTION | 3 | 3 | |
| 65219-281-02 | Gadobutrol | 5 in 1 BOX | INJECTION | 5 | 3 | |
| 65219-281-03 | Gadobutrol | 7.5 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 7.5 | 3 | |
| 65219-281-05 | Gadobutrol | 15 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 15 | 3 | |
| 65219-281-07 | Gadobutrol | 10 in 1 CARTON | INJECTION | 10 | 3 | |
| 65219-281-07 | Gadobutrol | 2 in 1 BOX | INJECTION | 2 | 3 | |
| 65219-281-08 | Gadobutrol | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 | 3 | |
| 65219-281-10 | Gadobutrol | 10 in 1 CARTON | INJECTION | 10 | 3 | |
| 65219-281-10 | Gadobutrol | 2 in 1 BOX | INJECTION | 2 | 3 | |
| 65219-281-15 | Gadobutrol | 10 in 1 CARTON | INJECTION | 10 | 3 | |
| 65219-281-15 | Gadobutrol | 2 in 1 BOX | INJECTION | 2 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65219-281-00 | ML - Milliliter | 65219-281 | 273c0413-88f9-4927-970f-5828015629a2 | 1 | 2023-08-08 |
| 65219-281-02 | ML - Milliliter | 65219-281 | 940a2b60-1fab-41ce-82d4-15220f389691 | 1 | 2023-08-08 |
| 65219-281-03 | ML - Milliliter | 65219-281 | a4279d8f-cf98-4527-b747-9e196c1844a4 | 1 | 2023-08-08 |
| 65219-281-05 | ML - Milliliter | 65219-281 | 17da6f10-18c3-4d3d-bbae-3f715f703eb1 | 1 | 2023-08-08 |
| 65219-281-07 | ML - Milliliter | 65219-281 | b7d8a359-61db-4ded-a1e2-3c40eea22a5d | 1 | 2023-08-08 |
| 65219-281-08 | ML - Milliliter | 65219-281 | 1d458f43-36a1-4389-b635-1a91762ba078 | 1 | 2023-08-08 |
| 65219-281-10 | ML - Milliliter | 65219-281 | 99027c20-79d7-4c70-bfa9-78ad46fc19ca | 1 | 2023-08-08 |
| 65219-281-15 | ML - Milliliter | 65219-281 | 8980610e-44fb-43a8-8815-31a9866d08f0 | 1 | 2023-08-08 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Gadobutrol | GADOBUTROL | Fresenius Kabi USA, LLC | 007696d0-4b62-4937-9640-4ad619504df4 | 2025-07-15 | Boxed warning, Warnings, Adverse reactions | 215061 ANDA215061 65219-281 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 65219-281-00 | 65219028100 | 2 mL in 1 VIAL, SINGLE-DOSE | 2 ml | Historical | |||
| 65219-281-02 | 65219028102 | 5 CARTON in 1 BOX (65219-281-02) / 3 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE (65219-281-00) | 5 carton | 2023-04-14 | No | No | Current |
| 65219-281-03 | 65219028103 | 7.5 mL in 1 VIAL, SINGLE-DOSE | 7.5 ml | Historical | |||
| 65219-281-05 | 65219028105 | 15 mL in 1 VIAL, SINGLE-DOSE | 15 ml | Historical | |||
| 65219-281-07 | 65219028107 | 2 CARTON in 1 BOX (65219-281-07) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 7.5 mL in 1 VIAL, SINGLE-DOSE (65219-281-03) | 2 carton | 2023-04-14 | No | No | Current |
| 65219-281-08 | 65219028108 | 10 mL in 1 VIAL, SINGLE-DOSE | 10 ml | Historical | |||
| 65219-281-10 | 65219028110 | 2 CARTON in 1 BOX (65219-281-10) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE (65219-281-08) | 2 carton | 2023-04-14 | No | No | Current |
| 65219-281-15 | 65219028115 | 2 CARTON in 1 BOX (65219-281-15) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-DOSE (65219-281-05) | 2 carton | 2023-04-14 | No | No | Current |