Neomycin and Polymyxin B Sulfates

Product NDC
39822-1201
Requested package NDC
39822-1201-2
11-digit product format
398221201
Labeler code
39822
Product ID
39822-1201_4d508cf6-f6a4-be9f-e063-6394a90af91e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Neomycin and Polymyxin B Sulfates
Dosage form
SOLUTION
Route
IRRIGATION
Labeler
XGen Pharmaceuticals DJB, Inc.
Application
ANDA065106
Marketing category
ANDA
Marketing start
2006-01-19
Substance
NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
40; 200000 mg/mL; [USP'U]/mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage39822-120139822-1201-2DDiscontinued by firm2026-08-10

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
A065106-001NEOMYCIN AND POLYMYXIN B SULFATENEOMYCIN SULFATE; POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLSOLUTION / IRRIGATIONRS2006-01-31

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 UTC2026-02A065106-001NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLSOLUTION / IRRIGATIONRS2006-01-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065106-001NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLSOLUTION / IRRIGATIONAT2006-01-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065106-001NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLSOLUTION / IRRIGATIONAT2006-01-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065106-001NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLSOLUTION / IRRIGATIONAT2006-01-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065106-001NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLSOLUTION / IRRIGATIONAT2006-01-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065106-001NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLSOLUTION / IRRIGATIONAT2006-01-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065106-001NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLSOLUTION / IRRIGATIONAT2006-01-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065106-001NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLSOLUTION / IRRIGATIONAT2006-01-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065106-001NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLSOLUTION / IRRIGATIONAT2006-01-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065106-001NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLSOLUTION / IRRIGATIONAT2006-01-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065106-001NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLSOLUTION / IRRIGATIONAT2006-01-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065106-001NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLSOLUTION / IRRIGATIONAT2006-01-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065106-001NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLSOLUTION / IRRIGATIONAT2006-01-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065106-001NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLSOLUTION / IRRIGATIONAT2006-01-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065106-001NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLSOLUTION / IRRIGATIONAT2006-01-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065106-001NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLSOLUTION / IRRIGATIONAT2006-01-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065106-001NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLSOLUTION / IRRIGATIONAT2006-01-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065106-001NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLSOLUTION / IRRIGATIONAT2006-01-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065106-001NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLSOLUTION / IRRIGATIONAT2006-01-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065106-001NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLSOLUTION / IRRIGATIONAT2006-01-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065106-001NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLSOLUTION / IRRIGATIONAT2006-01-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A065106-001NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLSOLUTION / IRRIGATIONAT2006-01-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065106-001NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLSOLUTION / IRRIGATIONAT2006-01-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065106-001NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLSOLUTION / IRRIGATIONAT2006-01-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065106-001NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLSOLUTION / IRRIGATIONAT2006-01-313f01610625f2…
2019-09-15 20:21 UTC2019-09A065106-001NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLSOLUTION / IRRIGATIONAT2006-01-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A065106-001NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLSOLUTION / IRRIGATIONAT2006-01-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065106-001NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLSOLUTION / IRRIGATIONAT2006-01-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065106-001NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLSOLUTION / IRRIGATIONAT2006-01-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065106-001NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLSOLUTION / IRRIGATIONAT2006-01-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065106-001NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLSOLUTION / IRRIGATIONAT2006-01-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065106-001NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLSOLUTION / IRRIGATIONAT2006-01-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065106-001NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLSOLUTION / IRRIGATIONAT2006-01-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065106-001NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLSOLUTION / IRRIGATIONAT2006-01-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A065106-001NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLSOLUTION / IRRIGATIONAT2006-01-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A065106-001NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLSOLUTION / IRRIGATIONAT2006-01-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065106-001NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLSOLUTION / IRRIGATIONAT2006-01-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065106-001NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLSOLUTION / IRRIGATIONAT2006-01-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065106-001NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLSOLUTION / IRRIGATIONAT2006-01-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065106-001NEOMYCIN AND POLYMYXIN B SULFATEEQ 40MG BASE/ML;200,000 UNITS/MLSOLUTION / IRRIGATIONAT2006-01-31cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065106-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065106-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065106-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065106-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065106-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065106-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065106-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065106-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065106-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065106-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065106-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065106-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065106-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065106-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065106-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065106-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065106-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065106-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065106-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065106-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A065106-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065106-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065106-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065106-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A065106-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065106-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065106-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065106-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065106-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065106-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065106-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065106-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065106-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065106-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065106-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065106-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065106-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065106-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065106-001AT1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Neomycin and Polymyxin B Sulfates
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEOMYCIN SULFATE40 mg/mL
POLYMYXIN B SULFATE200000 [USP'U]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
057Y626693Internal UNII lookup
19371312D4Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
314124Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a2f47d77-efd3-4c84-a364-08fb6d9978ebAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
39822-1201-1Neomycin and Polymyxin B Sulfates1 mL in 1 AMPULESOLUTION118
39822-1201-2Neomycin and Polymyxin B Sulfates10 in 1 CARTONSOLUTION1018
39822-1201-5Neomycin and Polymyxin B Sulfates50 in 1 CARTONSOLUTION5018
39822-1201-5Neomycin and Polymyxin B Sulfates1 mL in 1 AMPULESOLUTION118

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
39822-1201-1ML - Milliliter39822-12015bc9d18c-836d-4684-ad92-17227aa725dd12012-07-24
39822-1201-2ML - Milliliter39822-120127d81ee6-315d-4f74-bd1c-781426bd1ca412012-07-24
39822-1201-5ML - Milliliter39822-1201ba3b45db-d677-4015-9431-0c0bf776cf8e12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
39822-1201NEOMYCIN AND POLYMYXIN B SULFATES SOLUTION [XGEN PHARMACEUTICALS DJB, INC.]16Current NDC, Legacy NDC, 4 package rows20231219_a2f47d77-efd3-4c84-a364-08fb6d9978eb.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 and Polymyxin B SulfatesNEOMYCIN AND POLYMYXIN B SULFATESXGen Pharmaceuticals DJB, Inc.a2f47d77-efd3-4c84-a364-08fb6d9978eb2026-03-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065106
application number: ANDA065106
ndc (package): 39822-1201-2
ndc (product): 39822-1201
ndc11 (package): 39822120102

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314124neomycin sulfate 40 MG / polymyxin B sulfate 200,000 UNT per mL Irrigation SolutionPSNa2f47d77-efd3-4c84-a364-08fb6d9978eb18
314124neomycin 40 MG/ML / polymyxin B 200000 UNT/ML Irrigation SolutionSCDa2f47d77-efd3-4c84-a364-08fb6d9978eb18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
39822-1201-23982212010210 AMPULE in 1 CARTON (39822-1201-2) > 1 mL in 1 AMPULE (39822-1201-1) 10 ampule2006-01-190000-00-00NoNoCurrent