Polymyxin B

Product NDC
39822-0166
11-digit product format
398220166
Labeler code
39822
Product ID
39822-0166_eedc47c0-5580-3069-e053-2995a90a0226
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Polymyxin B
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC
Labeler
XGen Pharmaceuticals DJB, Inc.
Application
ANDA063000
Marketing category
ANDA
Marketing start
1994-09-30
Marketing end
0000-00-00
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
2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct39822-0166DDiscontinued by firm2026-08-10
excluded packagepackage39822-016639822-0166-5DDiscontinued by firm2026-08-10
excluded packagepackage39822-016639822-0166-7DDiscontinued by firm2026-08-10

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 · 36 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 packagepackage39822-0166-5d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage39822-0166-7d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage39822-0166-5f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage39822-0166-7f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage39822-0166-52ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage39822-0166-72ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage39822-0166-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage39822-0166-7a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage39822-0166-5cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage39822-0166-7cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage39822-0166-5cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage39822-0166-7cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage39822-0166-5302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage39822-0166-7302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage39822-0166-5ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage39822-0166-7ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage39822-0166-50efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage39822-0166-70efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage39822-0166-5ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage39822-0166-7ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage39822-0166-5367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage39822-0166-7367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage39822-0166-5557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage39822-0166-7557ba5c1ecfa…9c80585c8c6e…

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
A063000-001POLYMYXIN B SULFATEPOLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTION1994-09-30

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 · 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 UTC2026-02A063000-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTION1994-09-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A063000-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTION1994-09-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A063000-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTION1994-09-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A063000-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP1994-09-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A063000-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP1994-09-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A063000-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP1994-09-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A063000-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP1994-09-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A063000-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP1994-09-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A063000-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP1994-09-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A063000-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP1994-09-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A063000-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP1994-09-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A063000-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP1994-09-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A063000-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP1994-09-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A063000-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP1994-09-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A063000-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP1994-09-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A063000-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP1994-09-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A063000-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP1994-09-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A063000-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP1994-09-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A063000-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP1994-09-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A063000-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP1994-09-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A063000-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP1994-09-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A063000-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP1994-09-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A063000-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP1994-09-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A063000-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP1994-09-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A063000-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP1994-09-303f01610625f2…
2019-09-15 20:21 UTC2019-09A063000-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP1994-09-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A063000-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP1994-09-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A063000-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP1994-09-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A063000-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP1994-09-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A063000-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP1994-09-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A063000-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP1994-09-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A063000-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP1994-09-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A063000-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP1994-09-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A063000-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP1994-09-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A063000-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP1994-09-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A063000-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP1994-09-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A063000-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP1994-09-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A063000-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP1994-09-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A063000-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP1994-09-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A063000-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP1994-09-30cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A063000-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A063000-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A063000-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A063000-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A063000-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A063000-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A063000-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A063000-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A063000-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A063000-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A063000-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A063000-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A063000-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A063000-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A063000-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A063000-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A063000-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A063000-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A063000-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A063000-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A063000-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A063000-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A063000-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A063000-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A063000-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A063000-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A063000-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A063000-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A063000-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A063000-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A063000-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A063000-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A063000-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A063000-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A063000-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A063000-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A063000-001AP1cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
39822-0166-5EA - Each39822-01663654b76a-9309-4ddd-b43b-26b934b43c0f12012-07-24
39822-0166-7EA - Each39822-016689ba6e6e-ea54-4672-9bb0-7503cf55d6ed12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4POLYMYXIN B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.]16
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KPOLYMYXIN B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.]16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
39822-0166-5398220166051 VIAL in 1 CARTON (39822-0166-5) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL1 vial1994-09-300000-00-00NoNoCurrent
39822-0166-7398220166071 VIAL in 1 CARTON (39822-0166-7) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL1 vial1994-09-300000-00-00NoNoCurrent