Home NDC 0338-0511-41 Gentamicin Sulfate in Sodium Chloride
Product NDC 0338-0511
Requested package NDC 0338-0511-41
11-digit product format 003380511
Labeler code 0338
Product ID 0338-0511_9372a876-0913-4312-bf12-be6837cab74f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gentamicin Sulfate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Baxter Healthcare Corporation
Application ANDA062373
Marketing category ANDA
Marketing start 1982-09-07
Substance GENTAMICIN SULFATE
Active strength 100 mg/50mL
Pharmacologic classes Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 10 matching rows.
Application-product, Trade name, Ingredient table 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.
Product history page 1 of 11 · 430 observed states.
Captured, Edition, Application-product table 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# Normalized TE history page 1 of 4 · 152 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Gentamicin Sulfate in Sodium Chloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GENTAMICIN SULFATE 100 mg/50mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0338-0511-41 Gentamicin Sulfate in Sodium Chloride 50 mL in 1 BAG INJECTION, SOLUTION 50 20
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0338-0511 GENTAMICIN SULFATE IN SODIUM CHLORIDE (GENTAMICIN SULFATE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] 19 Current NDC, Legacy NDC, 1 package rows 20250214_449c9a41-d61e-49fd-b5e3-d76f74b92acf.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0338-0511-41 00338051141 50 mL in 1 BAG (0338-0511-41) 50 ml 1982-09-07 0000-00-00 No No Current