polycin

Product NDC
53002-9270
11-digit product format
530029270
Labeler code
53002
Product ID
53002-9270_837c9f7c-b5bd-4e7c-9082-1bb5500c6ed3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bacitracin zinc and polymyxin b sulfates
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA065022
Marketing category
ANDA
Marketing start
2014-11-12
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
2021-12-31
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 productproduct53002-9270IInactivated by FDA2026-08-10
excluded packagepackage53002-927053002-9270-1IInactivated by FDA2026-08-10

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 · 22 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53002-9270-1IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53002-9270-1IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53002-9270-1IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53002-9270-1IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53002-9270-1IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53002-9270-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53002-9270-1UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53002-9270-1UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53002-9270-1UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53002-9270-1IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53002-9270-1IInactivated by FDA9bebd1f3094a…5416666fcb17…

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
A065022-001BACITRACIN ZINC AND POLYMYXIN B SULFATEBACITRACIN ZINC; POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC2002-02-27

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 UTC2026-02A065022-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2002-02-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065022-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2002-02-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A065022-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2002-02-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065022-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2002-02-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065022-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2002-02-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065022-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2002-02-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065022-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2002-02-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065022-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2002-02-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065022-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2002-02-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065022-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2002-02-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065022-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2002-02-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065022-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2002-02-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065022-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2002-02-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065022-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2002-02-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065022-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2002-02-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065022-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2002-02-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065022-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2002-02-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065022-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2002-02-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065022-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2002-02-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065022-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2002-02-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065022-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2002-02-2787673890dc5c…
2021-03-12 10:30 UTC2021-03A065022-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2002-02-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065022-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2002-02-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065022-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2002-02-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065022-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2002-02-273f01610625f2…
2019-09-15 20:21 UTC2019-09A065022-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2002-02-27b00525d2431f…
2019-07-19 19:46 UTC2019-07A065022-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2002-02-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065022-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2002-02-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065022-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2002-02-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065022-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2002-02-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065022-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2002-02-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065022-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2002-02-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065022-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2002-02-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065022-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2002-02-273f0d92c62455…
2023-05-13 08:27 UTC2023-05A065022-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2002-02-27053a50430f4f…
2023-01-26 05:58 UTC2023-01A065022-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2002-02-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065022-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2002-02-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065022-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2002-02-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065022-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2002-02-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065022-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2002-02-27cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065022-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065022-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065022-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065022-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065022-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065022-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065022-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065022-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065022-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065022-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065022-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065022-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065022-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065022-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065022-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065022-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065022-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065022-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065022-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065022-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065022-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A065022-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065022-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065022-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065022-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A065022-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065022-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065022-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065022-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065022-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065022-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065022-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065022-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065022-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065022-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065022-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065022-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065022-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065022-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065022-001AT1cb3db0bc1861…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-9270-1polycin3.5 g in 1 TUBEOINTMENT3.55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-9270POLYCIN (BACITRACIN ZINC AND POLYMYXIN B SULFATES) OINTMENT [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 1 package rows20230609_8108496d-a5d0-45cc-bbbe-93d905bde167.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
polycinBACITRACIN ZINC AND POLYMYXIN B SULFATESNuCare Pharmaceuticals,Inc.5d55e918-98a0-4989-e053-2a91aa0a9ad72024-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065022
application number: ANDA065022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308511bacitracin zinc 500 UNT / polymyxin B sulfate 10,000 UNT per GM Ophthalmic OintmentPSN8108496d-a5d0-45cc-bbbe-93d905bde1675
213621Polycin 500 UNT/GM / 10,000 UNT/GM Ophthalmic OintmentPSN8108496d-a5d0-45cc-bbbe-93d905bde1675
213621bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Ophthalmic Ointment [Polycin]SBD8108496d-a5d0-45cc-bbbe-93d905bde1675
308511bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCD8108496d-a5d0-45cc-bbbe-93d905bde1675
308511bacitracin (as bacitracin zinc) 500 UNT / polymyxin B (as polymyxin B sulfate) 10,000 UNT per GM Ophthalmic OintmentSY8108496d-a5d0-45cc-bbbe-93d905bde1675
213621Polycin-B (bacitracin 500 UNT/GM / polymyxin B 10,000 UNT/GM) Ophthalmic OintmentSY8108496d-a5d0-45cc-bbbe-93d905bde1675

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-9270-1530029270013.5 g in 1 TUBE (53002-9270-1) 3.5 g2018-10-010000-00-00NoNoCurrent