FDA.reportPublic FDA data

Polymyxin B

Product NDC
25021-196
11-digit product format
250210196
Labeler code
25021
Product ID
25021-196_1d99f0e9-015c-4be1-b110-bdd156846dd1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Polymyxin B Sulfate
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA207322
Marketing category
ANDA
Marketing start
2025-10-01
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

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
A207322-001POLYMYXIN B SULFATEPOLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP2016-04-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A207322-001AP

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 UTC2026-02A207322-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP2016-04-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207322-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP2016-04-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A207322-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP2016-04-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207322-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP2016-04-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207322-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP2016-04-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207322-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP2016-04-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207322-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP2016-04-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207322-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP2016-04-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207322-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP2016-04-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207322-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP2016-04-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207322-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP2016-04-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207322-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP2016-04-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207322-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP2016-04-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207322-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP2016-04-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207322-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTION2016-04-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207322-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTION2016-04-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207322-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTION2016-04-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207322-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAPRS2016-04-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207322-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTION2016-04-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207322-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTION2016-04-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207322-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAPRS2016-04-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A207322-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAPRS2016-04-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207322-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAPRS2016-04-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207322-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAPRS2016-04-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207322-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAPRS2016-04-143f01610625f2…
2019-09-15 20:21 UTC2019-09A207322-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP2016-04-14b00525d2431f…
2019-07-19 19:46 UTC2019-07A207322-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP2016-04-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207322-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP2016-04-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207322-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP2016-04-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207322-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP2016-04-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207322-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP2016-04-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207322-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP2016-04-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207322-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP2016-04-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207322-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP2016-04-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A207322-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP2016-04-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A207322-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTIONAP2016-04-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207322-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTION2016-04-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207322-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTION2016-04-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207322-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTION2016-04-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207322-001POLYMYXIN B SULFATEEQ 500,000 UNITS BASE/VIALINJECTABLE / INJECTION2016-04-14cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207322-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207322-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207322-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207322-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207322-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207322-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207322-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207322-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207322-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207322-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207322-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207322-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207322-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207322-001AP18072bd15b7f6…
2019-12-13 00:20 UTC2019-12A207322-001AP174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207322-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A207322-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207322-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207322-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207322-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A207322-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A207322-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207322-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207322-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207322-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207322-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207322-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207322-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207322-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A207322-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A207322-001AP13bdfa0b2c4d7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207322-001AP1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POLYMYXIN B SULFATE500000 [USP'U]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
19371312D4Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
204509Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7dc505aa-64b0-4b7f-8ee3-2945bde40a34Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25021-196-10Polymyxin B10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,101
25021-196-10Polymyxin B1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-196-10EA - Each25021-196a035376a-60dd-4943-b461-07b505caa0c112025-10-14

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Polymyxin BPOLYMYXIN B SULFATESagent Pharmaceuticals7dc505aa-64b0-4b7f-8ee3-2945bde40a342025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207322
application number: ANDA207322
ndc (product): 25021-196
POLYMYXIN BPOLYMYXIN B SULFATEFOSUN PHARMA USA INCfd664927-db58-a1af-e053-6294a90a90482025-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207322
application number: ANDA207322
POLYMYXIN BPOLYMYXIN B SULFATEGland Pharma Limiteddc74dee2-1d0b-4fab-a29b-1755fdb5da752025-05-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207322
application number: ANDA207322

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204509polymyxin B Variable Concentration Multi-Use Injectable SolutionPSN7dc505aa-64b0-4b7f-8ee3-2945bde40a341
204509polymyxin B 250000 UNT/ML Injectable SolutionSCD7dc505aa-64b0-4b7f-8ee3-2945bde40a341

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-196-102502101961010 VIAL in 1 CARTON (25021-196-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL10 vial2025-10-01NoNoCurrent