Home NDC 63323-330 Nafcillin
Product NDC 63323-330
11-digit product format 633230330
Labeler code 63323
Product ID 63323-330_8b27ca5e-a933-7606-e053-2a95a90a0a33
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name NAFCILLIN
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA090005
Marketing category ANDA
Marketing start 2011-04-27
Substance NAFCILLIN SODIUM
Active strength 10 g/100mL
Pharmacologic classes Penicillin-class Antibacterial [EPC], Penicillins [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 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 A090005-001 NAFCILLIN SODIUM NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2011-04-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090005-001 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 A090005-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2011-04-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090005-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2011-04-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090005-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2011-04-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090005-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2011-04-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090005-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2011-04-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090005-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2011-04-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090005-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2011-04-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090005-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2011-04-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090005-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2011-04-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090005-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2011-04-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090005-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2011-04-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090005-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2011-04-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090005-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2011-04-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090005-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2011-04-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090005-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2011-04-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090005-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2011-04-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090005-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2011-04-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090005-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2011-04-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090005-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2011-04-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090005-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2011-04-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090005-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2011-04-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090005-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2011-04-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090005-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2011-04-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090005-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2011-04-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090005-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2011-04-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090005-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2011-04-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090005-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2011-04-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090005-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2011-04-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090005-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2011-04-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090005-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2011-04-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090005-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2011-04-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090005-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2011-04-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090005-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2011-04-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090005-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2011-04-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090005-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2011-04-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090005-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2011-04-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090005-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2011-04-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090005-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2011-04-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090005-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2011-04-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090005-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2011-04-20 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 Nafcillin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NAFCILLIN SODIUM 10 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 49G3001BCK Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 239189 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 63323-330-60 Nafcillin 1 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 1 7 63323-330-60 Nafcillin 100 mL in 1 VIAL, PHARMACY BULK PACKAGE INJECTION, POWDER, FOR SOLUTION 100 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NAFCILLIN SODIUM ACTIVE INGREDIENT 49G3001BCK NAFCILLIN INJECTION, POWDER, FOR SOLUTION [APP PHARMACEUTICALS, LLC] 3 NAFCILLIN ACTIVE MOIETY 4CNZ27M7RV NAFCILLIN INJECTION, POWDER, FOR SOLUTION [APP PHARMACEUTICALS, LLC] 3 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR NAFCILLIN INJECTION, POWDER, FOR SOLUTION [APP PHARMACEUTICALS, LLC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-330 NAFCILLIN INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC] 7 Current NDC, Legacy NDC, 2 package rows 20190613_bbf0d8e4-b8e4-4958-b6b6-f0b9960f3b6a.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Nafcillin NAFCILLIN WG Critical Care, LLC 77999cd2-17b8-4df9-b687-d0f9b62096b9 2026-06-24 Warnings, Adverse reactions Exact identifier application applno (ANDA): 090005 application number: ANDA090005 Nafcillin NAFCILLIN SODIUM Sagent Pharmaceuticals a6a4e122-b7f5-4eb5-8555-7aea6eda794b 2025-04-27 Warnings, Adverse reactions Exact identifier application applno (ANDA): 090005 application number: ANDA090005 Nafcillin NAFCILLIN SODIUM Avenacy Inc. 0556378a-b794-4235-ba09-ebdc295e9092 2025-02-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 090005 application number: ANDA090005 Nafcillin NAFCILLIN NorthStar Rx, LLC 91ebf84a-310f-4271-8446-5a10a877883a 2024-02-27 Warnings, Adverse reactions Exact identifier application applno (ANDA): 090005 application number: ANDA090005 Nafcillin NAFCILLIN Fresenius Kabi USA, LLC bbf0d8e4-b8e4-4958-b6b6-f0b9960f3b6a 2019-06-12 Warnings, Adverse reactions Exact identifier application applno (ANDA): 090005 application number: ANDA090005 ndc (product): 63323-330
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63323-330-60 63323033060 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (63323-330-60) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE 2011-04-27 0000-00-00 No No Current