Home NDC 63323-367-11 Polymyxin B
Product NDC 63323-367
Requested package NDC 63323-367-11
11-digit product format 633230367
Labeler code 63323
Product ID 63323-367_5cf9b65b-6df4-42f8-b395-d0cf0a1003d3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Polymyxin B Sulfate
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA202766
Marketing category ANDA
Marketing start 2015-09-09
Substance POLYMYXIN B SULFATE
Active strength 500000 [USP'U]/1
Pharmacologic classes 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202766-001 POLYMYXIN B SULFATE POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2014-01-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202766-001 AP
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A202766-001 POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2014-01-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202766-001 POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2014-01-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202766-001 POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2014-01-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202766-001 POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2014-01-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202766-001 POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2014-01-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202766-001 POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2014-01-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202766-001 POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2014-01-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202766-001 POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2014-01-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202766-001 POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2014-01-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202766-001 POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2014-01-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202766-001 POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2014-01-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202766-001 POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2014-01-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202766-001 POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2014-01-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202766-001 POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2014-01-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202766-001 POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2014-01-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202766-001 POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2014-01-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202766-001 POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2014-01-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202766-001 POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2014-01-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202766-001 POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2014-01-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202766-001 POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2014-01-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202766-001 POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2014-01-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202766-001 POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2014-01-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202766-001 POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2014-01-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202766-001 POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2014-01-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202766-001 POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2014-01-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202766-001 POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2014-01-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202766-001 POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2014-01-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202766-001 POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2014-01-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202766-001 POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2014-01-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202766-001 POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2014-01-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202766-001 POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2014-01-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202766-001 POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2014-01-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202766-001 POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2014-01-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202766-001 POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2014-01-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202766-001 POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2014-01-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202766-001 POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2014-01-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202766-001 POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2014-01-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202766-001 POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2014-01-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202766-001 POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2014-01-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202766-001 POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2014-01-15 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Polymyxin B
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POLYMYXIN B SULFATE 500000 [USP'U]/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 19371312D4 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 204509 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63323-367-41 Polymyxin B 1 in 1 VIAL, GLASS INJECTION, POWDER, LYOPHILIZED, 1 2 63323-367-44 Polymyxin B 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded POLYMYXIN B SULFATE ACTIVE INGREDIENT 19371312D4 POLYMYXIN B (POLYMYXIN B SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 1 POLYMYXIN B ACTIVE MOIETY J2VZ07J96K POLYMYXIN B (POLYMYXIN B SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-367 POLYMYXIN B (POLYMYXIN B SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 2 Current NDC, Legacy NDC, 2 package rows 20221203_72dd6de6-31d6-4a8f-881b-91af91ed9314.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63323-367-11 63323036711 10 VIAL in 1 CARTON (63323-367-11) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-367-01) 10 vial 2015-09-09 0000-00-00 No No Current