FDA.reportPublic FDA data

polycin

Product NDC
66267-925
11-digit product format
662670925
Labeler code
66267
Product ID
66267-925_1fa7a635-8d93-58f2-e063-6394a90ab77e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bacitracin zinc and polymyxin b sulfates
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA065022
Marketing category
ANDA
Marketing start
2014-11-12
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
2026-12-31
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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66267-925-35557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66267-925-358af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66267-925-35834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66267-925-351332a3947898…d4bfe170f9cd…

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…

Additional Listing Data#

Finished product
Yes
Brand name base
polycin
Listing expiration
2026-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
213621Internal RxNorm lookup
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
5d55e918-98a0-4989-e053-2a91aa0a9ad7Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66267-925-352024-08-14C16284748780-1f386c64a-22d6-0266-e053-dadaa90a7c1aPolycin® bacitracin zinc and polymyxin B sulfate Ophthalmic Ointment USP STERILE Rx Only
66267-925-352023-01-30C16284748780-1f386c64a-22d6-0266-e053-dadaa90a7c1aPolycin® bacitracin zinc and polymyxin B sulfate Ophthalmic Ointment USP STERILE Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66267-925-35polycin3.5 g in 1 TUBEOINTMENT3.55

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66267-925-35GM - Gram66267-92502e24ccb-6495-4d65-877a-aed3eca6ed2312017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-925POLYCIN (BACITRACIN ZINC AND POLYMYXIN B SULFATES) OINTMENT [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 1 package rows20240816_5d55e918-98a0-4989-e053-2a91aa0a9ad7.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
ndc (product): 66267-925

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 OintmentPSN5d55e918-98a0-4989-e053-2a91aa0a9ad75
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 OintmentSCD5d55e918-98a0-4989-e053-2a91aa0a9ad75
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 OintmentSY5d55e918-98a0-4989-e053-2a91aa0a9ad75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66267-925-35662670925353.5 g in 1 TUBE (66267-925-35) 3.5 g2017-11-060000-00-00NoNoCurrent