Neomycin and Polymyxin B Sulfates and Bacitracin Zinc

Product NDC
24208-780
Requested package NDC
24208-780-55
11-digit product format
242080780
Labeler code
24208
Product ID
24208-780_2abff6dd-ac86-e766-e063-6394a90a9d70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Neomycin sulfate, Polymyxin B Sulfate and Bacitracin Zinc
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Bausch & Lomb Incorporated
Application
ANDA064064
Marketing category
ANDA
Marketing start
1995-10-30
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400; 3.5; 10000 [USP'U]/g; mg/g; [USP'U]/g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [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
A064064-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINCBACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-10-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A064064-001AT

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A064064-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-10-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A064064-001AT1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 Sulfates and Bacitracin ZincNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINCBausch & Lomb Incorporatedf3231f1c-665e-4efa-baa1-83bf296b2f8f2025-01-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064064
application number: ANDA064064
ndc (package): 24208-780-55
ndc (product): 24208-780
ndc11 (package): 24208078055

Additional Listing Data#

Finished product
Yes
Brand name base
Neomycin and Polymyxin B Sulfates and Bacitracin Zinc
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEOMYCIN SULFATE400 [USP'U]/g
POLYMYXIN B SULFATE3.5 mg/g
BACITRACIN ZINC10000 [USP'U]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
057Y626693Internal UNII lookup
19371312D4Internal UNII lookup
89Y4M234ESInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308493Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f3231f1c-665e-4efa-baa1-83bf296b2f8fAvailable 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
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24208-780-55Neomycin and Polymyxin B Sulfates and Bacitracin Zinc1 in 1 CARTONOINTMENT114
24208-780-55Neomycin and Polymyxin B Sulfates and Bacitracin Zinc3.5 g in 1 TUBEOINTMENT3.514

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24208-780-55GM - Gram24208-78064224556-80ef-4dbc-8727-e3cc191b591812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ESNEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [BAUSCH & LOMB INCORPORATED]4
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [BAUSCH & LOMB INCORPORATED]4
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [BAUSCH & LOMB INCORPORATED]4
BACITRACINACTIVE MOIETY58H6RWO52INEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [BAUSCH & LOMB INCORPORATED]4
NEOMYCINACTIVE MOIETYI16QD7X297NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [BAUSCH & LOMB INCORPORATED]4
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KNEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [BAUSCH & LOMB INCORPORATED]4
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPNEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [BAUSCH & LOMB INCORPORATED]4
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UNEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [BAUSCH & LOMB INCORPORATED]4
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ESNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC (NEOMYCIN, POLYMYXIN B AND BACITRACIN ZINC) OINTMENT [STAT RX USA LLC]1
Bacitracin ZincACTIVE INGREDIENT89Y4M234ESNEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [REBEL DISTRIBUTORS CORP]1
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ESNEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC (NEOMYCIN, POLYMYXIN B AND BACITRACIN ZINC) OINTMENT [STAT RX USA LLC]1
Neomycin SulfateACTIVE INGREDIENT057Y626693NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [REBEL DISTRIBUTORS CORP]1
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC (NEOMYCIN, POLYMYXIN B AND BACITRACIN ZINC) OINTMENT [STAT RX USA LLC]1
Polymyxin B SulfateACTIVE INGREDIENT19371312D4NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [REBEL DISTRIBUTORS CORP]1
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
BacitracinACTIVE MOIETY58H6RWO52INEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [REBEL DISTRIBUTORS CORP]1
BACITRACINACTIVE MOIETY58H6RWO52INEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC (NEOMYCIN, POLYMYXIN B AND BACITRACIN ZINC) OINTMENT [STAT RX USA LLC]1
BACITRACINACTIVE MOIETY58H6RWO52INEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
NeomycinACTIVE MOIETYI16QD7X297NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [REBEL DISTRIBUTORS CORP]1
NEOMYCINACTIVE MOIETYI16QD7X297NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
NEOMYCINACTIVE MOIETYI16QD7X297NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC (NEOMYCIN, POLYMYXIN B AND BACITRACIN ZINC) OINTMENT [STAT RX USA LLC]1
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KNEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC (NEOMYCIN, POLYMYXIN B AND BACITRACIN ZINC) OINTMENT [STAT RX USA LLC]1
polymyxin BACTIVE MOIETYJ2VZ07J96KNEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [REBEL DISTRIBUTORS CORP]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPNEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC (NEOMYCIN, POLYMYXIN B AND BACITRACIN ZINC) OINTMENT [STAT RX USA LLC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPNEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [REBEL DISTRIBUTORS CORP]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UNEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC (NEOMYCIN, POLYMYXIN B AND BACITRACIN ZINC) OINTMENT [STAT RX USA LLC]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UNEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-780NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [BAUSCH & LOMB INCORPORATED]14Current NDC, Legacy NDC, 2 package rows20250104_f3231f1c-665e-4efa-baa1-83bf296b2f8f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308493bacitracin zinc 400 UNT / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per GM Ophthalmic OintmentPSNf3231f1c-665e-4efa-baa1-83bf296b2f8f14
308493bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCDf3231f1c-665e-4efa-baa1-83bf296b2f8f14
308493bacitracin 0.4 UNT/MG / neomycin 0.35 % / polymyxin B 10 UNT/MG Ophthalmic OintmentSYf3231f1c-665e-4efa-baa1-83bf296b2f8f14
308493bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT per GM Ophthalmic OintmentSYf3231f1c-665e-4efa-baa1-83bf296b2f8f14
308493bacitracin zinc 400 UNT / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per GM Ophthalmic OintmentPSN65b71a14-dcb5-4123-b4c5-033c9e16a22a1
308493bacitracin zinc 400 UNT / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per GM Ophthalmic OintmentPSNafaeb6c5-3841-4695-b42d-0ecc3a73dfe81
308493bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCD65b71a14-dcb5-4123-b4c5-033c9e16a22a1
308493bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCDafaeb6c5-3841-4695-b42d-0ecc3a73dfe81
308493bacitracin 0.4 UNT/MG / neomycin 0.35 % / polymyxin B 10 UNT/MG Ophthalmic OintmentSY65b71a14-dcb5-4123-b4c5-033c9e16a22a1
308493bacitracin 0.4 UNT/MG / neomycin 0.35 % / polymyxin B 10 UNT/MG Ophthalmic OintmentSYafaeb6c5-3841-4695-b42d-0ecc3a73dfe81
308493bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT per GM Ophthalmic OintmentSY65b71a14-dcb5-4123-b4c5-033c9e16a22a1
308493bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT per GM Ophthalmic OintmentSYafaeb6c5-3841-4695-b42d-0ecc3a73dfe81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24208-780-55242080780551 TUBE in 1 CARTON (24208-780-55) / 3.5 g in 1 TUBE1 tube1995-10-300000-00-00NoNoCurrent