polycin

Product NDC
0574-4021
11-digit product format
005744021
Labeler code
0574
Product ID
0574-4021_c304d2f8-68d7-4199-90b5-fb5b14e9b45c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bacitracin zinc and polymyxin b sulfates
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Padagis US LLC
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
2022-12-31
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 productproduct0574-4021DDiscontinued by firm2026-08-10
excluded packagepackage0574-40210574-4021-35DDiscontinued by firm2026-08-10

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0574-4021-35GM - Gram0574-4021b2626785-53a7-46c7-a0ef-f82da1186ba112015-01-05

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0574-4021POLYCIN (BACITRACIN ZINC AND POLYMYXIN B SULFATES) OINTMENT [PADAGIS US LLC]4Legacy NDC20241109_3abbfb58-26d1-460d-a60f-db63c0193a0d.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
308511bacitracin zinc 500 UNT / polymyxin B sulfate 10,000 UNT per GM Ophthalmic OintmentPSN5d55e918-98a0-4989-e053-2a91aa0a9ad75
213621Polycin 500 UNT/GM / 10,000 UNT/GM Ophthalmic OintmentPSN8108496d-a5d0-45cc-bbbe-93d905bde1675
213621Polycin 500 UNT/GM / 10,000 UNT/GM Ophthalmic OintmentPSN5d55e918-98a0-4989-e053-2a91aa0a9ad75
213621bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Ophthalmic Ointment [Polycin]SBD8108496d-a5d0-45cc-bbbe-93d905bde1675
213621bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Ophthalmic Ointment [Polycin]SBD5d55e918-98a0-4989-e053-2a91aa0a9ad75
308511bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCD8108496d-a5d0-45cc-bbbe-93d905bde1675
308511bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCD5d55e918-98a0-4989-e053-2a91aa0a9ad75
308511bacitracin (as bacitracin zinc) 500 UNT / polymyxin B (as polymyxin B sulfate) 10,000 UNT per GM Ophthalmic OintmentSY8108496d-a5d0-45cc-bbbe-93d905bde1675
308511bacitracin (as bacitracin zinc) 500 UNT / polymyxin B (as polymyxin B sulfate) 10,000 UNT per GM Ophthalmic OintmentSY5d55e918-98a0-4989-e053-2a91aa0a9ad75
213621Polycin-B (bacitracin 500 UNT/GM / polymyxin B 10,000 UNT/GM) Ophthalmic OintmentSY8108496d-a5d0-45cc-bbbe-93d905bde1675
213621Polycin-B (bacitracin 500 UNT/GM / polymyxin B 10,000 UNT/GM) Ophthalmic OintmentSY5d55e918-98a0-4989-e053-2a91aa0a9ad75
308511bacitracin zinc 500 UNT / polymyxin B sulfate 10,000 UNT per GM Ophthalmic OintmentPSN4be2ae47-ce1e-6212-e054-00144ff88e882
213621Polycin 500 UNT/GM / 10,000 UNT/GM Ophthalmic OintmentPSN4be2ae47-ce1e-6212-e054-00144ff88e882
213621bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Ophthalmic Ointment [Polycin]SBD4be2ae47-ce1e-6212-e054-00144ff88e882
308511bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCD4be2ae47-ce1e-6212-e054-00144ff88e882
308511bacitracin (as bacitracin zinc) 500 UNT / polymyxin B (as polymyxin B sulfate) 10,000 UNT per GM Ophthalmic OintmentSY4be2ae47-ce1e-6212-e054-00144ff88e882
213621Polycin-B (bacitracin 500 UNT/GM / polymyxin B 10,000 UNT/GM) Ophthalmic OintmentSY4be2ae47-ce1e-6212-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0574-4021-35005744021351 TUBE in 1 CARTON (0574-4021-35) > 3.5 g in 1 TUBE1 tube2014-11-120000-00-00NoNoCurrent