Bacitracin Zinc and Polymyxin B Sulfate

Product NDC
50090-7189
11-digit product format
500907189
Labeler code
50090
Product ID
50090-7189_325d8b12-136d-4848-96c5-46c8d0d2702c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bacitracin Zinc and Polymyxin B Sulfate
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
Application
ANDA064046
Marketing category
ANDA
Marketing start
2008-04-25
Substance
BACITRACIN ZINC; POLYMYXIN B SULFATE
Active strength
500; 10000 [USP'U]/g; [USP'U]/g
Pharmacologic classes
Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct50090-7189DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-718950090-7189-0DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATEBACITRACIN ZINC; POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICRS1995-01-26

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICRS1995-01-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-263f01610625f2…
2019-09-15 20:21 UTC2019-09A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-26e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A064046-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064046-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A064046-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064046-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064046-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064046-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064046-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064046-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064046-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A064046-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064046-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064046-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064046-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064046-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064046-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064046-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064046-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064046-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064046-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064046-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A064046-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A064046-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A064046-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A064046-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A064046-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A064046-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A064046-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A064046-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A064046-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A064046-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A064046-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A064046-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A064046-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A064046-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A064046-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A064046-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A064046-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A064046-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A064046-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A064046-001AT1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Bacitracin Zinc and Polymyxin B Sulfate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC500 [USP'U]/g
POLYMYXIN B SULFATE10000 [USP'U]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
89Y4M234ESInternal 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
308511Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
19b4cfab-5927-47c5-a032-58ab2998d9c7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7189-0Bacitracin Zinc and Polymyxin B Sulfate3.5 g in 1 TUBEOINTMENT3.54
50090-7189-0Bacitracin Zinc and Polymyxin B Sulfate144 in 1 CASEOINTMENT1444

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7189-0GM - Gram50090-71890aebd148-9720-4795-9c9c-07b29c41542912024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7189BACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20240706_19b4cfab-5927-47c5-a032-58ab2998d9c7.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bacitracin Zinc and Polymyxin B SulfateBACITRACIN ZINC AND POLYMYXIN B SULFATEA-S Medication Solutions51f6eac3-205e-4beb-8522-6ba2c593f3502026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064046
application number: ANDA064046
Bacitracin Zinc and Polymyxin B SulfateBACITRACIN ZINC AND POLYMYXIN B SULFATEA-S Medication Solutions19b4cfab-5927-47c5-a032-58ab2998d9c72026-01-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064046
application number: ANDA064046
ndc (product): 50090-7189
Bacitracin Zinc and Polymyxin B SulfateBACITRACIN ZINC AND POLYMYXIN B SULFATENuCare Pharmaceuticals,Inc.a73654f4-949d-3da4-e053-2995a90a1fc32024-12-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064046
application number: ANDA064046
Bacitracin Zinc and Polymyxin B SulfateBACITRACIN ZINC AND POLYMYXIN B SULFATEBausch & Lomb Incorporated1b317249-30eb-4415-8a1c-cfedb4ba35492024-10-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064046
application number: ANDA064046

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308511bacitracin zinc 500 UNT / polymyxin B sulfate 10,000 UNT per GM Ophthalmic OintmentPSN19b4cfab-5927-47c5-a032-58ab2998d9c74
308511bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCD19b4cfab-5927-47c5-a032-58ab2998d9c74
308511bacitracin (as bacitracin zinc) 500 UNT / polymyxin B (as polymyxin B sulfate) 10,000 UNT per GM Ophthalmic OintmentSY19b4cfab-5927-47c5-a032-58ab2998d9c74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7189-050090718900144 TUBE in 1 CASE (50090-7189-0) / 3.5 g in 1 TUBE144 tube2024-07-02NoNoCurrent