Home NDC 63323-113 Pentam 300
Product NDC 63323-113
11-digit product format 633230113
Labeler code 63323
Product ID 63323-113_5fe83fb0-2b64-40a2-a996-aaa6292e661e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PENTAMIDINE ISETHIONATE
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application NDA019264
Marketing category NDA
Marketing start 2001-01-16
Substance PENTAMIDINE ISETHIONATE
Active strength 300 mg/3mL
Pharmacologic classes Antiprotozoal [EPC]
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019264-001 PENTAM PENTAMIDINE ISETHIONATE 300MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1984-10-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N019264-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 N019264-001 PENTAM 300MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1984-10-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019264-001 PENTAM 300MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1984-10-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019264-001 PENTAM 300MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1984-10-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019264-001 PENTAM 300MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1984-10-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019264-001 PENTAM 300MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1984-10-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019264-001 PENTAM 300MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1984-10-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019264-001 PENTAM 300MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1984-10-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019264-001 PENTAM 300MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1984-10-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019264-001 PENTAM 300MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1984-10-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019264-001 PENTAM 300MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1984-10-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019264-001 PENTAM 300MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1984-10-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019264-001 PENTAM 300MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1984-10-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019264-001 PENTAM 300MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1984-10-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019264-001 PENTAM 300MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1984-10-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019264-001 PENTAM 300MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1984-10-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019264-001 PENTAM 300MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1984-10-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019264-001 PENTAM 300MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1984-10-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019264-001 PENTAM 300MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1984-10-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019264-001 PENTAM 300MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1984-10-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019264-001 PENTAM 300MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1984-10-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019264-001 PENTAM 300MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1984-10-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019264-001 PENTAM 300MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1984-10-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019264-001 PENTAM 300MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1984-10-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019264-001 PENTAM 300MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1984-10-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019264-001 PENTAM 300MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1984-10-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019264-001 PENTAM 300MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1984-10-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019264-001 PENTAM 300MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1984-10-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019264-001 PENTAM 300MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1984-10-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019264-001 PENTAM 300MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1984-10-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019264-001 PENTAM 300MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1984-10-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019264-001 PENTAM 300MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1984-10-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019264-001 PENTAM 300MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1984-10-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019264-001 PENTAM 300MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1984-10-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019264-001 PENTAM 300MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1984-10-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019264-001 PENTAM 300MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1984-10-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019264-001 PENTAM 300MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1984-10-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019264-001 PENTAM 300MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1984-10-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019264-001 PENTAM 300MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1984-10-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019264-001 PENTAM 300MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1984-10-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N019264-001 PENTAM 300MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1984-10-16 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Pentam 300
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PENTAMIDINE ISETHIONATE 300 mg/3mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V2P3K60DA2 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 861601 Internal RxNorm lookup 861604 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 63323-113-01 Pentam 300 3 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 3 3 63323-113-10 Pentam 300 10 in 1 TRAY INJECTION, POWDER, LYOPHILIZED, 10 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PENTAMIDINE ISETHIONATE ACTIVE INGREDIENT V2P3K60DA2 PENTAM 300 (PENTAMIDINE ISETHIONATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC] 1 PENTAMIDINE ACTIVE MOIETY 673LC5J4LQ PENTAM 300 (PENTAMIDINE ISETHIONATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-113 PENTAM 300 (PENTAMIDINE ISETHIONATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 3 Current NDC, Legacy NDC, 2 package rows 20220919_cc2b635e-4840-4dc3-a177-5484371680e8.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.
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 63323-113-01 63323011301 3 mL in 1 VIAL 3 ml Historical 63323-113-10 63323011310 10 VIAL in 1 TRAY (63323-113-10) / 3 mL in 1 VIAL (63323-113-01) 10 vial 2001-01-16 0000-00-00 No No Current