Bacitracin Zinc and Polymyxin B Sulfate

Product NDC
21695-156
11-digit product format
216950156
Labeler code
21695
Product ID
21695-156_dc47903e-8d29-43eb-a647-1e8d28232bb9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bacitracin Zinc and Polymyxin B Sulfate
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Rebel Distributors Corp.
Application
ANDA064028
Marketing category
ANDA
Marketing start
1995-01-30
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
E
Listing certified through
2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct21695-156IInactivated by FDA2026-09-14
excluded packagepackage21695-15621695-156-35IInactivated by FDA2026-09-14

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-156-35d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-156-35f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-156-352ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-156-35a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-156-35cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-156-35cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-156-35302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-156-35ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-156-350efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-156-35ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-156-35367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-156-35557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-156-358af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-156-35834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-156-351332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-156-35fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-156-3586f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-156-35bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-156-358dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-156-35e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage21695-156-359bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage21695-156-35110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A064028-001BACITRACIN ZINC AND POLYMYXIN B SULFATEBACITRACIN ZINC; POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC1995-01-30

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A064028-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC1995-01-3084e616aacf4f…
2026-08-18 06:07:402026-07A064028-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC1995-01-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A064028-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC1995-01-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064028-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC1995-01-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A064028-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC1995-01-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064028-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC1995-01-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064028-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC1995-01-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064028-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC1995-01-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064028-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC1995-01-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064028-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC1995-01-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064028-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC1995-01-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A064028-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC1995-01-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064028-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC1995-01-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064028-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC1995-01-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064028-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1995-01-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064028-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1995-01-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064028-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1995-01-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064028-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1995-01-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064028-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1995-01-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064028-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1995-01-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064028-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1995-01-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064028-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1995-01-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A064028-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1995-01-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A064028-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1995-01-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A064028-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1995-01-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A064028-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1995-01-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A064028-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1995-01-303f01610625f2…
2019-09-15 20:21 UTC2019-09A064028-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1995-01-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A064028-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1995-01-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A064028-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1995-01-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A064028-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1995-01-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A064028-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1995-01-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A064028-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1995-01-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A064028-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1995-01-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A064028-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1995-01-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A064028-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1995-01-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A064028-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1995-01-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A064028-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1995-01-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A064028-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1995-01-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A064028-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT1995-01-30f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064028-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064028-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064028-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064028-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064028-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064028-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064028-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064028-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A064028-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A064028-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A064028-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A064028-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A064028-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A064028-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A064028-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A064028-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A064028-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A064028-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A064028-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A064028-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A064028-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A064028-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A064028-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A064028-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A064028-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A064028-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A064028-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A064028-001AT1cb3db0bc1861…

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
21695-156-352019-09-24C16284748780-1934fe258-4932-48b1-e053-8cdaa90a720aBacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment USP, Sterile

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-156-35Bacitracin Zinc and Polymyxin B Sulfate3.5 g in 1 TUBEOINTMENT3.51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-156-35GM - Gram21695-15623bf45ae-37c8-4849-a327-d07d3da1495212012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-156BACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 1 package rows20101210_dc47903e-8d29-43eb-a647-1e8d28232bb9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308511bacitracin zinc 500 UNT / polymyxin B sulfate 10,000 UNT per GM Ophthalmic OintmentPSNdc47903e-8d29-43eb-a647-1e8d28232bb91
308511bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCDdc47903e-8d29-43eb-a647-1e8d28232bb91
308511bacitracin (as bacitracin zinc) 500 UNT / polymyxin B (as polymyxin B sulfate) 10,000 UNT per GM Ophthalmic OintmentSYdc47903e-8d29-43eb-a647-1e8d28232bb91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-156-35216950156353.5 g in 1 TUBE3.5 gHistorical