Neomycin Sulfate

Product NDC
73473-901
11-digit product format
734730901
Labeler code
73473
Product ID
73473-901_40441079-4a76-b56f-e063-6394a90a5765
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Neomycin Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Solaris Pharma Corporation
Application
ANDA065220
Marketing category
ANDA
Marketing start
2023-06-01
Substance
NEOMYCIN SULFATE
Active strength
500 mg/1
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065220-001NEOMYCIN SULFATENEOMYCIN SULFATE500MGTABLET / ORALAA2006-07-28

Therapeutic equivalence codes#

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

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

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065220-001NEOMYCIN SULFATE500MGTABLET / ORALAA2006-07-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065220-001NEOMYCIN SULFATE500MGTABLET / ORALAA2006-07-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A065220-001NEOMYCIN SULFATE500MGTABLET / ORALAA2006-07-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065220-001NEOMYCIN SULFATE500MGTABLET / ORALAA2006-07-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065220-001NEOMYCIN SULFATE500MGTABLET / ORALAA2006-07-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065220-001NEOMYCIN SULFATE500MGTABLET / ORALAA2006-07-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065220-001NEOMYCIN SULFATE500MGTABLET / ORALAA2006-07-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065220-001NEOMYCIN SULFATE500MGTABLET / ORALAA2006-07-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065220-001NEOMYCIN SULFATE500MGTABLET / ORALAA2006-07-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065220-001NEOMYCIN SULFATE500MGTABLET / ORALAA2006-07-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065220-001NEOMYCIN SULFATE500MGTABLET / ORALAA2006-07-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065220-001NEOMYCIN SULFATE500MGTABLET / ORALAA2006-07-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065220-001NEOMYCIN SULFATE500MGTABLET / ORALAA2006-07-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065220-001NEOMYCIN SULFATE500MGTABLET / ORALAA2006-07-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065220-001NEOMYCIN SULFATE500MGTABLET / ORALAA2006-07-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065220-001NEOMYCIN SULFATE500MGTABLET / ORALAA2006-07-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065220-001NEOMYCIN SULFATE500MGTABLET / ORALAA2006-07-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065220-001NEOMYCIN SULFATE500MGTABLET / ORALAA2006-07-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065220-001NEOMYCIN SULFATE500MGTABLET / ORALAA2006-07-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065220-001NEOMYCIN SULFATE500MGTABLET / ORALAA2006-07-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065220-001NEOMYCIN SULFATE500MGTABLET / ORALAA2006-07-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A065220-001NEOMYCIN SULFATE500MGTABLET / ORALAA2006-07-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065220-001NEOMYCIN SULFATE500MGTABLET / ORALAA2006-07-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065220-001NEOMYCIN SULFATE500MGTABLET / ORALAA2006-07-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065220-001NEOMYCIN SULFATE500MGTABLET / ORALAA2006-07-283f01610625f2…
2019-09-15 20:21 UTC2019-09A065220-001NEOMYCIN SULFATE500MGTABLET / ORALAA2006-07-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A065220-001NEOMYCIN SULFATE500MGTABLET / ORALAA2006-07-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065220-001NEOMYCIN SULFATE500MGTABLET / ORALAA2006-07-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065220-001NEOMYCIN SULFATE500MGTABLET / ORALAA2006-07-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065220-001NEOMYCIN SULFATE500MGTABLET / ORALAA2006-07-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065220-001NEOMYCIN SULFATE500MGTABLET / ORALAA2006-07-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065220-001NEOMYCIN SULFATE500MGTABLET / ORALAA2006-07-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065220-001NEOMYCIN SULFATE500MGTABLET / ORALAA2006-07-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065220-001NEOMYCIN SULFATE500MGTABLET / ORALAA2006-07-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A065220-001NEOMYCIN SULFATE500MGTABLET / ORALAA2006-07-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A065220-001NEOMYCIN SULFATE500MGTABLET / ORALAA2006-07-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065220-001NEOMYCIN SULFATE500MGTABLET / ORALAA2006-07-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065220-001NEOMYCIN SULFATE500MGTABLET / ORALAA2006-07-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065220-001NEOMYCIN SULFATE500MGTABLET / ORALAA2006-07-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065220-001NEOMYCIN SULFATE500MGTABLET / ORALAA2006-07-28cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065220-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065220-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065220-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065220-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065220-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065220-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065220-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065220-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065220-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065220-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065220-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065220-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065220-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065220-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065220-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065220-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065220-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065220-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065220-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065220-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065220-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A065220-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065220-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065220-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065220-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A065220-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065220-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065220-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065220-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065220-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065220-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065220-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065220-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065220-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065220-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065220-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065220-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065220-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065220-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065220-001AA1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Neomycin Sulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEOMYCIN SULFATE500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
057Y626693Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
866042Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f430c5d9-ae82-3314-e053-2a95a90af04cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73473-901-05Neomycin Sulfate100 in 1 BOTTLE, PLASTICTABLET1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73473-901-05EA - Each73473-9010e3c64c1-8919-46c6-80cb-e295431f138012023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73473-901NEOMYCIN SULFATE TABLET [SOLARIS PHARMA CORPORATION]2Current NDC, 1 package rows20240608_f430c5d9-ae82-3314-e053-2a95a90af04c.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neomycin SulfateNEOMYCIN SULFATESolaris Pharma Corporationf430c5d9-ae82-3314-e053-2a95a90af04c2025-10-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065220
application number: ANDA065220
ndc (product): 73473-901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866042neomycin sulfate 500 MG Oral TabletPSNf430c5d9-ae82-3314-e053-2a95a90af04c3
866042neomycin sulfate 500 MG Oral TabletSCDf430c5d9-ae82-3314-e053-2a95a90af04c3
866042neomycin sulfate 500 MG (neomycin 350 MG) Oral TabletSYf430c5d9-ae82-3314-e053-2a95a90af04c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73473-901-0573473090105100 TABLET in 1 BOTTLE, PLASTIC (73473-901-05) 100 tablet2023-06-01NoNoCurrent