Gentamicin Sulfate in Sodium Chloride

Product NDC
0338-0507
11-digit product format
003380507
Labeler code
0338
Product ID
0338-0507_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
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 44.

Orange Book products#

Current product rows page 1 of 1 · 10 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A062373-001GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEEQ 0.8MG BASE/MLINJECTABLE / INJECTION1982-09-07
A062373-002GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEEQ 80MG BASE/100MLINJECTABLE / INJECTION1982-09-07
A062373-003GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEEQ 40MG BASE/100MLINJECTABLE / INJECTION1982-09-07
A062373-004GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEEQ 60MG BASE/100MLINJECTABLE / INJECTION1982-09-07
A062373-005GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEEQ 100MG BASE/100MLINJECTABLE / INJECTION1982-09-07
A062373-006GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEEQ 120MG BASE/100MLINJECTABLE / INJECTIONRS1982-09-07
A062373-007GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEEQ 1.2MG BASE/MLINJECTABLE / INJECTION1982-09-07
A062373-008GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEEQ 1.6MG BASE/MLINJECTABLE / INJECTION1982-09-07
A062373-009GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEEQ 2MG BASE/MLINJECTABLE / INJECTIONRS1982-09-07
A062373-010GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGENTAMICIN SULFATEEQ 2.4MG BASE/MLINJECTABLE / INJECTION1982-09-07

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 · 440 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A062373-001GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 0.8MG BASE/MLINJECTABLE / INJECTION1982-09-07c2088c7a36db…
2026-10-15 13:18:302026-09A062373-002GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 80MG BASE/100MLINJECTABLE / INJECTION1982-09-07c2088c7a36db…
2026-10-15 13:18:302026-09A062373-003GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 40MG BASE/100MLINJECTABLE / INJECTION1982-09-07c2088c7a36db…
2026-10-15 13:18:302026-09A062373-004GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 60MG BASE/100MLINJECTABLE / INJECTION1982-09-07c2088c7a36db…
2026-10-15 13:18:302026-09A062373-005GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 100MG BASE/100MLINJECTABLE / INJECTION1982-09-07c2088c7a36db…
2026-10-15 13:18:302026-09A062373-006GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 120MG BASE/100MLINJECTABLE / INJECTIONRS1982-09-07c2088c7a36db…
2026-10-15 13:18:302026-09A062373-007GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 1.2MG BASE/MLINJECTABLE / INJECTION1982-09-07c2088c7a36db…
2026-10-15 13:18:302026-09A062373-008GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 1.6MG BASE/MLINJECTABLE / INJECTION1982-09-07c2088c7a36db…
2026-10-15 13:18:302026-09A062373-009GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 2MG BASE/MLINJECTABLE / INJECTIONRS1982-09-07c2088c7a36db…
2026-10-15 13:18:302026-09A062373-010GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 2.4MG BASE/MLINJECTABLE / INJECTION1982-09-07c2088c7a36db…
2026-09-14 22:38:342026-08A062373-001GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 0.8MG BASE/MLINJECTABLE / INJECTION1982-09-0784e616aacf4f…
2026-09-14 22:38:342026-08A062373-002GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 80MG BASE/100MLINJECTABLE / INJECTION1982-09-0784e616aacf4f…
2026-09-14 22:38:342026-08A062373-003GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 40MG BASE/100MLINJECTABLE / INJECTION1982-09-0784e616aacf4f…
2026-09-14 22:38:342026-08A062373-004GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 60MG BASE/100MLINJECTABLE / INJECTION1982-09-0784e616aacf4f…
2026-09-14 22:38:342026-08A062373-005GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 100MG BASE/100MLINJECTABLE / INJECTION1982-09-0784e616aacf4f…
2026-09-14 22:38:342026-08A062373-006GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 120MG BASE/100MLINJECTABLE / INJECTIONRS1982-09-0784e616aacf4f…
2026-09-14 22:38:342026-08A062373-007GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 1.2MG BASE/MLINJECTABLE / INJECTION1982-09-0784e616aacf4f…
2026-09-14 22:38:342026-08A062373-008GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 1.6MG BASE/MLINJECTABLE / INJECTION1982-09-0784e616aacf4f…
2026-09-14 22:38:342026-08A062373-009GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 2MG BASE/MLINJECTABLE / INJECTIONRS1982-09-0784e616aacf4f…
2026-09-14 22:38:342026-08A062373-010GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 2.4MG BASE/MLINJECTABLE / INJECTION1982-09-0784e616aacf4f…
2026-08-18 06:07:402026-07A062373-001GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 0.8MG BASE/MLINJECTABLE / INJECTION1982-09-07caaa826d4ba7…
2026-08-18 06:07:402026-07A062373-002GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 80MG BASE/100MLINJECTABLE / INJECTION1982-09-07caaa826d4ba7…
2026-08-18 06:07:402026-07A062373-003GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 40MG BASE/100MLINJECTABLE / INJECTION1982-09-07caaa826d4ba7…
2026-08-18 06:07:402026-07A062373-004GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 60MG BASE/100MLINJECTABLE / INJECTION1982-09-07caaa826d4ba7…
2026-08-18 06:07:402026-07A062373-005GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 100MG BASE/100MLINJECTABLE / INJECTION1982-09-07caaa826d4ba7…
2026-08-18 06:07:402026-07A062373-006GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 120MG BASE/100MLINJECTABLE / INJECTIONRS1982-09-07caaa826d4ba7…
2026-08-18 06:07:402026-07A062373-007GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 1.2MG BASE/MLINJECTABLE / INJECTION1982-09-07caaa826d4ba7…
2026-08-18 06:07:402026-07A062373-008GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 1.6MG BASE/MLINJECTABLE / INJECTION1982-09-07caaa826d4ba7…
2026-08-18 06:07:402026-07A062373-009GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 2MG BASE/MLINJECTABLE / INJECTIONRS1982-09-07caaa826d4ba7…
2026-08-18 06:07:402026-07A062373-010GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 2.4MG BASE/MLINJECTABLE / INJECTION1982-09-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A062373-001GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 0.8MG BASE/MLINJECTABLE / INJECTION1982-09-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062373-002GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 80MG BASE/100MLINJECTABLE / INJECTION1982-09-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062373-003GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 40MG BASE/100MLINJECTABLE / INJECTION1982-09-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062373-004GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 60MG BASE/100MLINJECTABLE / INJECTION1982-09-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062373-005GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 100MG BASE/100MLINJECTABLE / INJECTION1982-09-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062373-006GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 120MG BASE/100MLINJECTABLE / INJECTIONRS1982-09-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062373-007GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 1.2MG BASE/MLINJECTABLE / INJECTION1982-09-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062373-008GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 1.6MG BASE/MLINJECTABLE / INJECTION1982-09-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062373-009GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 2MG BASE/MLINJECTABLE / INJECTIONRS1982-09-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062373-010GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINEREQ 2.4MG BASE/MLINJECTABLE / INJECTION1982-09-07011fe1cb6892…

Observed Orange Book normalized TE history#

Normalized TE history page 4 of 4 · 152 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A062373-002AP1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A062373-005AP1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A062373-007AP1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A062373-008AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A062373-002AP13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A062373-005AP13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A062373-007AP13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A062373-008AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A062373-002AP1053a50430f4f…
2023-05-13 08:27 UTC2023-05A062373-005AP1053a50430f4f…
2023-05-13 08:27 UTC2023-05A062373-007AP1053a50430f4f…
2023-05-13 08:27 UTC2023-05A062373-008AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A062373-002AP13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A062373-005AP13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A062373-007AP13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A062373-008AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A062373-002AP13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A062373-005AP13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A062373-007AP13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A062373-008AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A062373-002AP1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A062373-005AP1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A062373-007AP1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A062373-008AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A062373-002AP1e64feba35796…
2022-09-29 23:25 UTC2022-09A062373-005AP1e64feba35796…
2022-09-29 23:25 UTC2022-09A062373-007AP1e64feba35796…
2022-09-29 23:25 UTC2022-09A062373-008AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A062373-002AP1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A062373-005AP1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A062373-007AP1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A062373-008AP1cb3db0bc1861…

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
IngredientStrength
GENTAMICIN SULFATE60 mg/50mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3b7b3a7a-635f-32a3-0c6c-7ad028e3de91Product name220250107
43025f0d-698c-68da-cec9-ea4261a7ef7aProduct name220250107
d3946667-8212-d1f2-67e1-5643a329bb56Product name220200403
4ce5dce5-e8a7-e4f6-0059-b527e4307477Product name220190501
48b05f5d-d2fc-45ab-76e8-3cb5bd44890dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0338-0507-41Gentamicin Sulfate in Sodium Chloride50 mL in 1 BAGINJECTION, SOLUTION5020
0338-0507-48Gentamicin Sulfate in Sodium Chloride100 mL in 1 BAGINJECTION, SOLUTION10020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-0507-41ML - Milliliter0338-05072b1cfbe1-a313-4b6e-9dfe-3905d111127812012-07-24
0338-0507-48ML - Milliliter0338-05070d07c5fb-fde8-49c4-93f0-3c892d89b53712012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-0507GENTAMICIN SULFATE IN SODIUM CHLORIDE (GENTAMICIN SULFATE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]19Current NDC, Legacy NDC, 2 package rows20250214_449c9a41-d61e-49fd-b5e3-d76f74b92acf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242816gentamicin sulfate 100 MG in 100 ML InjectionPSN449c9a41-d61e-49fd-b5e3-d76f74b92acf20
197736gentamicin sulfate 100 MG in 50 ML InjectionPSN449c9a41-d61e-49fd-b5e3-d76f74b92acf20
1870631gentamicin sulfate 120 MG in 100 ML InjectionPSN449c9a41-d61e-49fd-b5e3-d76f74b92acf20
1870633gentamicin sulfate 60 MG in 50 ML InjectionPSN449c9a41-d61e-49fd-b5e3-d76f74b92acf20
310473gentamicin sulfate 80 MG in 100 ML InjectionPSN449c9a41-d61e-49fd-b5e3-d76f74b92acf20
310477gentamicin sulfate 80 MG in 50 ML InjectionPSN449c9a41-d61e-49fd-b5e3-d76f74b92acf20
310473100 ML gentamicin 0.8 MG/ML InjectionSCD449c9a41-d61e-49fd-b5e3-d76f74b92acf20
242816100 ML gentamicin 1 MG/ML InjectionSCD449c9a41-d61e-49fd-b5e3-d76f74b92acf20
1870631100 ML gentamicin 1.2 MG/ML InjectionSCD449c9a41-d61e-49fd-b5e3-d76f74b92acf20
187063350 ML gentamicin 1.2 MG/ML InjectionSCD449c9a41-d61e-49fd-b5e3-d76f74b92acf20
31047750 ML gentamicin 1.6 MG/ML InjectionSCD449c9a41-d61e-49fd-b5e3-d76f74b92acf20
19773650 ML gentamicin 2 MG/ML InjectionSCD449c9a41-d61e-49fd-b5e3-d76f74b92acf20
242816gentamicin (as gentamicin sulfate) 100 MG per 100 ML InjectionSY449c9a41-d61e-49fd-b5e3-d76f74b92acf20
197736gentamicin (as gentamicin sulfate) 100 MG per 50 ML InjectionSY449c9a41-d61e-49fd-b5e3-d76f74b92acf20
1870631gentamicin (as gentamicin sulfate) 120 MG per 100 ML InjectionSY449c9a41-d61e-49fd-b5e3-d76f74b92acf20
1870633gentamicin (as gentamicin sulfate) 60 MG per 50 ML InjectionSY449c9a41-d61e-49fd-b5e3-d76f74b92acf20
310473gentamicin (as gentamicin sulfate) 80 MG per 100 ML InjectionSY449c9a41-d61e-49fd-b5e3-d76f74b92acf20
310477gentamicin (as gentamicin sulfate) 80 MG per 50 ML InjectionSY449c9a41-d61e-49fd-b5e3-d76f74b92acf20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0338-0507-410033805074150 mL in 1 BAG (0338-0507-41) 50 ml1982-09-070000-00-00NoNoCurrent
0338-0507-4800338050748100 mL in 1 BAG (0338-0507-48) 100 ml1982-09-070000-00-00NoNoCurrent