National Council for Prescription Drug Programs indexing - billing unit
- Manufacturer
- National Council for Prescription Drug Programs
- Effective date
- 2012-07-24
- Label type
- Indexing - Billing Unit
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-05 02:01:29
Label at a glance#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0338-0505-48 | ML - Milliliter | 0338-0505 | 6f877670-e256-49f2-97f8-83f84aa2bb8a | 1 | 2012-07-24 |
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0338-0505 | 0338-0505-48 |
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 |
|---|---|---|---|---|---|---|---|
| A062373-001 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 0.8MG BASE/ML | INJECTABLE / INJECTION | 1982-09-07 | ||
| A062373-002 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 80MG BASE/100ML | INJECTABLE / INJECTION | 1982-09-07 | ||
| A062373-003 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 40MG BASE/100ML | INJECTABLE / INJECTION | 1982-09-07 | ||
| A062373-004 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 60MG BASE/100ML | INJECTABLE / INJECTION | 1982-09-07 | ||
| A062373-005 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 100MG BASE/100ML | INJECTABLE / INJECTION | 1982-09-07 | ||
| A062373-006 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 120MG BASE/100ML | INJECTABLE / INJECTION | RS | 1982-09-07 | |
| A062373-007 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 1.2MG BASE/ML | INJECTABLE / INJECTION | 1982-09-07 | ||
| A062373-008 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 1.6MG BASE/ML | INJECTABLE / INJECTION | 1982-09-07 | ||
| A062373-009 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | RS | 1982-09-07 | |
| A062373-010 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | GENTAMICIN SULFATE | EQ 2.4MG BASE/ML | INJECTABLE / INJECTION | 1982-09-07 |
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 | A062373-001 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 0.8MG BASE/ML | INJECTABLE / INJECTION | 1982-09-07 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062373-002 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 80MG BASE/100ML | INJECTABLE / INJECTION | 1982-09-07 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062373-003 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 40MG BASE/100ML | INJECTABLE / INJECTION | 1982-09-07 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062373-004 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 60MG BASE/100ML | INJECTABLE / INJECTION | 1982-09-07 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062373-005 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 100MG BASE/100ML | INJECTABLE / INJECTION | 1982-09-07 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062373-006 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 120MG BASE/100ML | INJECTABLE / INJECTION | RS | 1982-09-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A062373-007 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 1.2MG BASE/ML | INJECTABLE / INJECTION | 1982-09-07 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062373-008 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 1.6MG BASE/ML | INJECTABLE / INJECTION | 1982-09-07 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062373-009 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 2MG BASE/ML | INJECTABLE / INJECTION | RS | 1982-09-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A062373-010 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 2.4MG BASE/ML | INJECTABLE / INJECTION | 1982-09-07 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062373-001 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 0.8MG BASE/ML | INJECTABLE / INJECTION | 1982-09-07 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062373-002 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 80MG BASE/100ML | INJECTABLE / INJECTION | 1982-09-07 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062373-003 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 40MG BASE/100ML | INJECTABLE / INJECTION | 1982-09-07 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062373-004 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 60MG BASE/100ML | INJECTABLE / INJECTION | 1982-09-07 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062373-005 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 100MG BASE/100ML | INJECTABLE / INJECTION | 1982-09-07 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062373-006 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 120MG BASE/100ML | INJECTABLE / INJECTION | RS | 1982-09-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A062373-007 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 1.2MG BASE/ML | INJECTABLE / INJECTION | 1982-09-07 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062373-008 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 1.6MG BASE/ML | INJECTABLE / INJECTION | 1982-09-07 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062373-009 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 2MG BASE/ML | INJECTABLE / INJECTION | RS | 1982-09-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A062373-010 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 2.4MG BASE/ML | INJECTABLE / INJECTION | 1982-09-07 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062373-001 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 0.8MG BASE/ML | INJECTABLE / INJECTION | 1982-09-07 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062373-002 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 80MG BASE/100ML | INJECTABLE / INJECTION | 1982-09-07 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062373-003 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 40MG BASE/100ML | INJECTABLE / INJECTION | 1982-09-07 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062373-004 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 60MG BASE/100ML | INJECTABLE / INJECTION | 1982-09-07 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062373-005 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 100MG BASE/100ML | INJECTABLE / INJECTION | 1982-09-07 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062373-006 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 120MG BASE/100ML | INJECTABLE / INJECTION | RS | 1982-09-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A062373-007 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 1.2MG BASE/ML | INJECTABLE / INJECTION | 1982-09-07 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062373-008 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 1.6MG BASE/ML | INJECTABLE / INJECTION | 1982-09-07 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062373-009 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 2MG BASE/ML | INJECTABLE / INJECTION | RS | 1982-09-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A062373-010 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 2.4MG BASE/ML | INJECTABLE / INJECTION | 1982-09-07 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062373-001 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 0.8MG BASE/ML | INJECTABLE / INJECTION | 1982-09-07 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062373-002 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 80MG BASE/100ML | INJECTABLE / INJECTION | 1982-09-07 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062373-003 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 40MG BASE/100ML | INJECTABLE / INJECTION | 1982-09-07 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062373-004 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 60MG BASE/100ML | INJECTABLE / INJECTION | 1982-09-07 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062373-005 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 100MG BASE/100ML | INJECTABLE / INJECTION | 1982-09-07 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062373-006 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 120MG BASE/100ML | INJECTABLE / INJECTION | RS | 1982-09-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062373-007 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 1.2MG BASE/ML | INJECTABLE / INJECTION | 1982-09-07 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062373-008 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 1.6MG BASE/ML | INJECTABLE / INJECTION | 1982-09-07 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062373-009 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 2MG BASE/ML | INJECTABLE / INJECTION | RS | 1982-09-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062373-010 | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 2.4MG BASE/ML | INJECTABLE / INJECTION | 1982-09-07 | 31067a03dcf5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-08-23 18:47 UTC | 2025-08 | A062373-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A062373-005 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A062373-007 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A062373-008 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062373-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062373-005 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062373-007 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062373-008 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062373-002 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062373-005 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062373-007 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062373-008 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062373-002 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062373-005 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062373-007 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062373-008 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062373-002 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062373-005 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062373-007 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062373-008 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062373-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062373-005 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062373-007 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062373-008 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062373-002 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062373-005 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062373-007 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062373-008 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A062373-002 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A062373-005 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A062373-007 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A062373-008 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062373-002 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062373-005 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062373-007 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062373-008 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062373-002 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062373-005 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062373-007 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062373-008 | AP | 1 | 301d65b070ca… |
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 |
|---|---|---|---|---|---|---|
| Gentamicin Sulfate in Sodium Chloride | GENTAMICIN SULFATE | Baxter Healthcare Corporation | 449c9a41-d61e-49fd-b5e3-d76f74b92acf | 2023-01-26 | Boxed warning, Warnings, Adverse reactions | 0338-0505-48 00338050548 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.