Neomycin Sulfate

Product NDC: 39822-0310
11-digit product format: 398220310
Labeler code: 39822
Product ID: 39822-0310_d810b504-2761-e94f-e053-2a95a90ae498
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Neomycin Sulfate
Dosage form: TABLET
Route: ORAL
Labeler: XGen Pharmaceuticals DJB, Inc.
Application: ANDA065220
Marketing category: ANDA
Marketing start: 2010-03-12
Marketing end: 0000-00-00
Substance: NEOMYCIN SULFATE
Active strength: 500 mg/1
Pharmacologic classes: Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	39822-0310		D	Discontinued by firm		2026-08-10
excluded package	package	39822-0310	39822-0310-5	D	Discontinued by firm		2026-08-10

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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	39822-0310		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	39822-0310	39822-0310-5	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065220-001	NEOMYCIN SULFATE	NEOMYCIN SULFATE	500MG	TABLET / ORAL	AA		2006-07-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065220-001	AA

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 2 · 41 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	A065220-001	NEOMYCIN SULFATE	500MG	TABLET / ORAL	AA	2006-07-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065220-001	NEOMYCIN SULFATE	500MG	TABLET / ORAL	AA	2006-07-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065220-001	NEOMYCIN SULFATE	500MG	TABLET / ORAL	AA	2006-07-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065220-001	NEOMYCIN SULFATE	500MG	TABLET / ORAL	AA	2006-07-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065220-001	NEOMYCIN SULFATE	500MG	TABLET / ORAL	AA	2006-07-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065220-001	NEOMYCIN SULFATE	500MG	TABLET / ORAL	AA	2006-07-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065220-001	NEOMYCIN SULFATE	500MG	TABLET / ORAL	AA	2006-07-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065220-001	NEOMYCIN SULFATE	500MG	TABLET / ORAL	AA	2006-07-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065220-001	NEOMYCIN SULFATE	500MG	TABLET / ORAL	AA	2006-07-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065220-001	NEOMYCIN SULFATE	500MG	TABLET / ORAL	AA	2006-07-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065220-001	NEOMYCIN SULFATE	500MG	TABLET / ORAL	AA	2006-07-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065220-001	NEOMYCIN SULFATE	500MG	TABLET / ORAL	AA	2006-07-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065220-001	NEOMYCIN SULFATE	500MG	TABLET / ORAL	AA	2006-07-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065220-001	NEOMYCIN SULFATE	500MG	TABLET / ORAL	AA	2006-07-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065220-001	NEOMYCIN SULFATE	500MG	TABLET / ORAL	AA	2006-07-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065220-001	NEOMYCIN SULFATE	500MG	TABLET / ORAL	AA	2006-07-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065220-001	NEOMYCIN SULFATE	500MG	TABLET / ORAL	AA	2006-07-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065220-001	NEOMYCIN SULFATE	500MG	TABLET / ORAL	AA	2006-07-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065220-001	NEOMYCIN SULFATE	500MG	TABLET / ORAL	AA	2006-07-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065220-001	NEOMYCIN SULFATE	500MG	TABLET / ORAL	AA	2006-07-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065220-001	NEOMYCIN SULFATE	500MG	TABLET / ORAL	AA	2006-07-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065220-001	NEOMYCIN SULFATE	500MG	TABLET / ORAL	AA	2006-07-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065220-001	NEOMYCIN SULFATE	500MG	TABLET / ORAL	AA	2006-07-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065220-001	NEOMYCIN SULFATE	500MG	TABLET / ORAL	AA	2006-07-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065220-001	NEOMYCIN SULFATE	500MG	TABLET / ORAL	AA	2006-07-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065220-001	NEOMYCIN SULFATE	500MG	TABLET / ORAL	AA	2006-07-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065220-001	NEOMYCIN SULFATE	500MG	TABLET / ORAL	AA	2006-07-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065220-001	NEOMYCIN SULFATE	500MG	TABLET / ORAL	AA	2006-07-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065220-001	NEOMYCIN SULFATE	500MG	TABLET / ORAL	AA	2006-07-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065220-001	NEOMYCIN SULFATE	500MG	TABLET / ORAL	AA	2006-07-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065220-001	NEOMYCIN SULFATE	500MG	TABLET / ORAL	AA	2006-07-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065220-001	NEOMYCIN SULFATE	500MG	TABLET / ORAL	AA	2006-07-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065220-001	NEOMYCIN SULFATE	500MG	TABLET / ORAL	AA	2006-07-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065220-001	NEOMYCIN SULFATE	500MG	TABLET / ORAL	AA	2006-07-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065220-001	NEOMYCIN SULFATE	500MG	TABLET / ORAL	AA	2006-07-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065220-001	NEOMYCIN SULFATE	500MG	TABLET / ORAL	AA	2006-07-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065220-001	NEOMYCIN SULFATE	500MG	TABLET / ORAL	AA	2006-07-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065220-001	NEOMYCIN SULFATE	500MG	TABLET / ORAL	AA	2006-07-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065220-001	NEOMYCIN SULFATE	500MG	TABLET / ORAL	AA	2006-07-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065220-001	NEOMYCIN SULFATE	500MG	TABLET / ORAL	AA	2006-07-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A065220-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065220-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065220-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065220-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065220-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065220-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065220-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065220-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065220-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065220-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065220-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065220-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065220-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065220-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065220-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065220-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065220-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065220-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065220-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065220-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065220-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065220-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065220-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065220-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065220-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065220-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065220-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065220-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065220-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065220-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065220-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065220-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065220-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065220-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065220-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065220-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065220-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065220-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065220-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065220-001	AA	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
39822-0310-5	EA - Each	39822-0310	2f55a80c-1254-46c9-ac72-473510d1fb21	1	2012-07-24
39822-0310-7	EA - Each	39822-0310	30818f52-db21-4034-9c9f-6d978ea25833	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NEOMYCIN SULFATE	ACTIVE INGREDIENT	057Y626693	NEOMYCIN SULFATE TABLET [X-GEN PHARMACEUTICALS, INC.]	7
NEOMYCIN	ACTIVE MOIETY	I16QD7X297	NEOMYCIN SULFATE TABLET [X-GEN PHARMACEUTICALS, INC.]	7
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	NEOMYCIN SULFATE TABLET [X-GEN PHARMACEUTICALS, INC.]	7
POVIDONE K29/32	INACTIVE INGREDIENT	390RMW2PEQ	NEOMYCIN SULFATE TABLET [X-GEN PHARMACEUTICALS, INC.]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
39822-0310	NEOMYCIN SULFATE TABLET [XGEN PHARMACEUTICALS DJB, INC.]	12	Legacy NDC	20240529_a35a558c-7d96-43fb-917b-475189772edd.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Neomycin Sulfate	NEOMYCIN SULFATE	Solaris Pharma Corporation	f430c5d9-ae82-3314-e053-2a95a90af04c	2025-10-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065220 application number: ANDA065220

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
057Y626693	NEOMYCIN SULFATE	1405-10-3	NEOMYCIN SULFATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
39822-0310-5	39822031005	100 BLISTER PACK in 1 BOX, UNIT-DOSE (39822-0310-5) > 1 TABLET in 1 BLISTER PACK (39822-0310-7)	100 blister pack	2010-03-12	0000-00-00	No	No	Current