BACITRACIN ZINC AND POLYMYXIN B SULFATE

Product NDC
72189-017
Requested package NDC
72189-017-35
11-digit product format
721890017
Labeler code
72189
Product ID
72189-017_8e6c9fb6-c8dc-20db-e053-2a95a90a3a86
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BACITRACIN ZINC AND POLYMYXIN B SULFATE
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Direct_Rx
Application
ANDA064046
Marketing category
ANDA
Marketing start
2019-07-24
Marketing end
0000-00-00
Substance
BACITRACIN ZINC; POLYMYXIN B SULFATE
Active strength
500 [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
2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage72189-01772189-017-35IInactivated by FDA2026-08-17

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 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72189-017-352023-01-30C16284748780-1f386c649-e07e-0266-e053-dadaa90a7c1aBACITRACIN ZINC AND POLYMYXIN B SULFATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-017-35BACITRACIN ZINC AND POLYMYXIN B SULFATE3.5 g in 1 BOTTLEOINTMENT3.51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-017-35GM - Gram72189-017ce456f34-cb5f-4595-9140-39b81438a87712019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-017BACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT [DIRECT_RX]1Legacy NDC, 1 package rows20190802_8e6c9fb6-c8db-20db-e053-2a95a90a3a86.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
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 OintmentPSN8e6c9fb6-c8db-20db-e053-2a95a90a3a861
308511bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCD8e6c9fb6-c8db-20db-e053-2a95a90a3a861
308511bacitracin (as bacitracin zinc) 500 UNT / polymyxin B (as polymyxin B sulfate) 10,000 UNT per GM Ophthalmic OintmentSY8e6c9fb6-c8db-20db-e053-2a95a90a3a861

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-017-35721890017353.5 g in 1 BOTTLE (72189-017-35) 3.5 g2019-07-240000-00-00NoNoCurrent