Home NDC 0338-0507 Gentamicin Sulfate in Sodium Chloride
Product NDC 0338-0507
11-digit product format 003380507
Labeler code 0338
Product ID 0338-0507_aacff3ac-5df9-4872-b074-78930c9c9b79
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 60 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 42 .
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 · 420 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 2026-08-18 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…2025-08-23 18:47 UTC 2025-08 A062373-001 GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER EQ 0.8MG BASE/ML INJECTABLE / INJECTION 1982-09-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A062373-002 GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER EQ 80MG BASE/100ML INJECTABLE / INJECTION AP 1982-09-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A062373-003 GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER EQ 40MG BASE/100ML INJECTABLE / INJECTION 1982-09-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A062373-004 GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER EQ 60MG BASE/100ML INJECTABLE / INJECTION 1982-09-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A062373-005 GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER EQ 100MG BASE/100ML INJECTABLE / INJECTION AP 1982-09-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A062373-006 GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER EQ 120MG BASE/100ML INJECTABLE / INJECTION RS 1982-09-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A062373-007 GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER EQ 1.2MG BASE/ML INJECTABLE / INJECTION AP 1982-09-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A062373-008 GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER EQ 1.6MG BASE/ML INJECTABLE / INJECTION AP 1982-09-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A062373-009 GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER EQ 2MG BASE/ML INJECTABLE / INJECTION RS 1982-09-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A062373-010 GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER EQ 2.4MG BASE/ML INJECTABLE / INJECTION 1982-09-07 6a471c1ec25d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 152 observed states.
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 60 mg/50mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8X7386QRLV Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197736 Internal RxNorm lookup 242816 Internal RxNorm lookup 310473 Internal RxNorm lookup 310477 Internal RxNorm lookup 1870631 Internal RxNorm lookup 1870633 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0338-0507-41 Gentamicin Sulfate in Sodium Chloride 50 mL in 1 BAG INJECTION, SOLUTION 50 20 0338-0507-48 Gentamicin Sulfate in Sodium Chloride 100 mL in 1 BAG INJECTION, SOLUTION 100 20
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0338-0507 GENTAMICIN SULFATE IN SODIUM CHLORIDE (GENTAMICIN SULFATE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] 19 Current NDC, Legacy NDC, 2 package rows 20250214_449c9a41-d61e-49fd-b5e3-d76f74b92acf.zip
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.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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 0338-0507-41 00338050741 50 mL in 1 BAG (0338-0507-41) 50 ml 1982-09-07 0000-00-00 No No Current 0338-0507-48 00338050748 100 mL in 1 BAG (0338-0507-48) 100 ml 1982-09-07 0000-00-00 No No Current