Gentamicin Sulfate

Product NDC: 0409-1207
Requested package NDC: 0409-1207-25
11-digit product format: 004091207
Labeler code: 0409
Product ID: 0409-1207_317c0976-12f8-4263-bcb5-66583d1a1cae
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: GENTAMICIN SULFATE
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Hospira, Inc.
Application: ANDA062420
Marketing category: ANDA
Marketing start: 2005-08-29
Substance: GENTAMICIN SULFATE
Active strength: 40 mg/mL
Pharmacologic classes: Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0409-1207	0409-1207-25	D	Discontinued by firm		excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0409-1207	0409-1207-25	D	Discontinued by firm		excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A062420-001	GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP		1983-08-15
A062420-002	GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP		1983-08-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A062420-001	AP
A062420-002	AP

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A062420-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062420-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062420-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062420-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062420-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062420-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062420-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062420-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062420-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062420-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062420-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062420-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062420-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062420-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062420-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062420-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062420-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062420-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062420-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062420-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062420-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062420-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062420-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062420-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062420-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062420-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062420-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062420-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062420-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062420-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062420-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062420-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062420-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062420-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062420-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062420-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062420-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062420-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062420-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062420-002	AP	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Gentamicin Sulfate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GENTAMICIN SULFATE	40 mg/mL

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1870650	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
977180b3-a222-4282-d485-4a3217674305	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3b7b3a7a-635f-32a3-0c6c-7ad028e3de91	Product name	2	20250107
43025f0d-698c-68da-cec9-ea4261a7ef7a	Product name	2	20250107
d3946667-8212-d1f2-67e1-5643a329bb56	Product name	2	20200403
4ce5dce5-e8a7-e4f6-0059-b527e4307477	Product name	2	20190501
48b05f5d-d2fc-45ab-76e8-3cb5bd44890d	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0409-1207-03	Gentamicin Sulfate	25 in 1 TRAY	INJECTION, SOLUTION	25		22
0409-1207-13	Gentamicin Sulfate	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	2		22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0409-1207-03	ML - Milliliter	0409-1207	b5d0f1ef-7c73-4fea-b4c9-9da361f74424	1	2012-07-24
0409-1207-13	ML - Milliliter	0409-1207	878db672-5c41-42ef-bba3-a1c57bc826c7	1	2018-02-20
0409-1207-15	ML - Milliliter	0409-1207	5582700a-cbe2-45e1-aec9-99f5c34a7dca	1	2019-04-11
0409-1207-25	ML - Milliliter	0409-1207	3e0f5a91-ba57-48c1-9414-b94a3427b02d	1	2016-03-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GENTAMICIN SULFATE	ACTIVE INGREDIENT	8X7386QRLV	GENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]	13
GENTAMICIN	ACTIVE MOIETY	T6Z9V48IKG	GENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]	13
EDETATE DISODIUM ANHYDROUS	INACTIVE INGREDIENT	8NLQ36F6MM	GENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]	13
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	GENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]	13
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	GENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]	13
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	GENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]	13
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	GENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]	13
SULFURIC ACID	INACTIVE INGREDIENT	O40UQP6WCF	GENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]	13
Gentamicin Sulfate	ACTIVE INGREDIENT	8X7386QRLV	GENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [CARDINAL HEALTH]	4
Gentamicin	ACTIVE MOIETY	T6Z9V48IKG	GENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [CARDINAL HEALTH]	4
EDETATE DISODIUM ANHYDROUS	INACTIVE INGREDIENT	8NLQ36F6MM	GENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [CARDINAL HEALTH]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	GENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [CARDINAL HEALTH]	4
NITROGEN	INACTIVE INGREDIENT	N762921K75	GENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [CARDINAL HEALTH]	4
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	GENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [CARDINAL HEALTH]	4
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	GENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [CARDINAL HEALTH]	4
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	GENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [CARDINAL HEALTH]	4
SULFURIC ACID	INACTIVE INGREDIENT	O40UQP6WCF	GENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [CARDINAL HEALTH]	4
Gentamicin Sulfate	ACTIVE INGREDIENT	8X7386QRLV	GENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [GENERAL INJECTABLES & VACCINES, INC]	1
GENTAMICIN SULFATE	ACTIVE INGREDIENT	8X7386QRLV	GENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]	1
Gentamicin	ACTIVE MOIETY	T6Z9V48IKG	GENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [GENERAL INJECTABLES & VACCINES, INC]	1
GENTAMICIN	ACTIVE MOIETY	T6Z9V48IKG	GENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]	1
EDETATE DISODIUM ANHYDROUS	INACTIVE INGREDIENT	8NLQ36F6MM	GENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	GENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	GENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	GENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]	1
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	GENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]	1
SULFURIC ACID	INACTIVE INGREDIENT	O40UQP6WCF	GENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0409-1207	GENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]	21	Current NDC, Legacy NDC, 2 package rows	20241218_977180b3-a222-4282-d485-4a3217674305.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gentamicin Sulfate	GENTAMICIN SULFATE	Hospira, Inc.	977180b3-a222-4282-d485-4a3217674305	2026-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062420 application number: ANDA062420 ndc (product): 0409-1207
Gentamicin Sulfate	GENTAMICIN SULFATE	Cardinal Health 107, LLC	5113bfad-42ca-4bb8-9343-0b08c6cd03f0	2026-05-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062420 application number: ANDA062420
Gentamicin Sulfate	GENTAMICIN SULFATE	Henry Schein, Inc.	913a36c3-50d6-429a-a8dd-a03126d2ca08	2025-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062420 application number: ANDA062420
Gentamicin Sulfate	GENTAMICIN SULFATE	Medical Purchasing Solutions, LLC	3532bb39-a1a6-9d67-e063-6294a90abc0c	2025-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062420 application number: ANDA062420
GENTAMICIN SULFATE	GENTAMICIN SULFATE	HF Acquisition Co LLC, DBA HealthFirst	e9fbe619-2afe-f1d7-e053-2a95a90aab29	2024-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062420 application number: ANDA062420
Gentamicin Sulfate	GENTAMICIN SULFATE	Medical Purchasing Solutions, LLC	a8b15217-cccb-2260-e053-2995a90a709d	2023-05-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062420 application number: ANDA062420

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8X7386QRLV	GENTAMICIN SULFATE	1405-41-0	GENTAMICIN SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1870650	gentamicin sulfate 80 MG in 2 ML Injection	PSN	977180b3-a222-4282-d485-4a3217674305	22
1870650	2 ML gentamicin 40 MG/ML Injection	SCD	977180b3-a222-4282-d485-4a3217674305	22
1870650	gentamicin (as gentamicin sulfate) 80 MG per 2 ML Injection	SY	977180b3-a222-4282-d485-4a3217674305	22
1870650	gentamicin sulfate 80 MG in 2 ML Injection	PSN	5113bfad-42ca-4bb8-9343-0b08c6cd03f0	14
1870650	2 ML gentamicin 40 MG/ML Injection	SCD	5113bfad-42ca-4bb8-9343-0b08c6cd03f0	14
1870650	gentamicin (as gentamicin sulfate) 80 MG per 2 ML Injection	SY	5113bfad-42ca-4bb8-9343-0b08c6cd03f0	14
1870650	gentamicin sulfate 80 MG in 2 ML Injection	PSN	913a36c3-50d6-429a-a8dd-a03126d2ca08	5
1870650	2 ML gentamicin 40 MG/ML Injection	SCD	913a36c3-50d6-429a-a8dd-a03126d2ca08	5
1870650	gentamicin (as gentamicin sulfate) 80 MG per 2 ML Injection	SY	913a36c3-50d6-429a-a8dd-a03126d2ca08	5
1870650	gentamicin sulfate 80 MG in 2 ML Injection	PSN	e9fbe619-2afe-f1d7-e053-2a95a90aab29	2
1870650	gentamicin sulfate 80 MG in 2 ML Injection	PSN	a8b15217-cccb-2260-e053-2995a90a709d	2
1870650	2 ML gentamicin 40 MG/ML Injection	SCD	e9fbe619-2afe-f1d7-e053-2a95a90aab29	2
1870650	2 ML gentamicin 40 MG/ML Injection	SCD	a8b15217-cccb-2260-e053-2995a90a709d	2
1870650	gentamicin (as gentamicin sulfate) 80 MG per 2 ML Injection	SY	e9fbe619-2afe-f1d7-e053-2a95a90aab29	2
1870650	gentamicin (as gentamicin sulfate) 80 MG per 2 ML Injection	SY	a8b15217-cccb-2260-e053-2995a90a709d	2
1870650	gentamicin sulfate 80 MG in 2 ML Injection	PSN	3532bb39-a1a6-9d67-e063-6294a90abc0c	1
1870650	2 ML gentamicin 40 MG/ML Injection	SCD	3532bb39-a1a6-9d67-e063-6294a90abc0c	1
1870650	gentamicin (as gentamicin sulfate) 80 MG per 2 ML Injection	SY	3532bb39-a1a6-9d67-e063-6294a90abc0c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0409-1207-25	00409120725	25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1207-25) > 2 mL in 1 VIAL, SINGLE-DOSE (0409-1207-15)	2015-12-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gentamicin Sulfate	Hospira, Inc.	2026-05-20	HUMAN PRESCRIPTION DRUG LABEL	22
Gentamicin Sulfate	Cardinal Health 107, LLC	2026-05-08	HUMAN PRESCRIPTION DRUG LABEL	14
Gentamicin Sulfate Injection, USP 80mg/2ml (40 mg/mL as Gentamicin)	Henry Schein, Inc.	2025-10-31	HUMAN PRESCRIPTION DRUG LABEL	5
Gentamicin Sulfate	Medical Purchasing Solutions, LLC	2025-05-15	HUMAN PRESCRIPTION DRUG LABEL	1
GENTAMICIN SULFATE INJECTION, USP 80mg/2mL (40mg/mL)	HF Acquisition Co LLC, DBA HealthFirst	2024-01-27	HUMAN PRESCRIPTION DRUG LABEL	2
Gentamicin Sulfate - Medical Purchasing Solutions, LLC	Medical Purchasing Solutions, LLC	2023-05-03	HUMAN PRESCRIPTION DRUG LABEL	2
Gentamicin Sulfate - Hospira, Inc. \| Lek d.d.	Hospira, Inc. \| Lek d.d.	2022-11-17	HUMAN PRESCRIPTION DRUG LABEL	9
Gentamicin Sulfate 80mg/2ml (40 mg/mL as Gentamicin)	General Injectables & Vaccines, Inc	2021-11-13	HUMAN PRESCRIPTION DRUG LABEL	6