Home NDC 55150-124 Nafcillin
Product NDC 55150-124
11-digit product format 551500124
Labeler code 55150
Product ID 55150-124_ed896790-4af4-446a-9d45-04c07d50980f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nafcillin Sodium
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Eugia US LLC
Application ANDA091614
Marketing category ANDA
Marketing start 2012-12-26
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 A091614-001 NAFCILLIN SODIUM NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-12-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091614-001 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 A091614-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-12-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091614-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-12-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091614-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-12-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091614-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-12-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091614-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-12-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091614-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-12-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091614-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-12-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091614-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-12-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091614-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-12-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091614-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-12-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091614-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-12-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091614-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-12-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091614-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-12-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091614-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-12-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091614-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-12-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091614-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2012-12-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091614-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2012-12-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091614-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2012-12-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091614-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2012-12-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091614-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2012-12-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091614-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2012-12-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091614-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2012-12-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091614-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2012-12-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091614-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2012-12-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091614-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2012-12-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091614-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2012-12-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091614-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2012-12-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091614-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2012-12-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091614-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-12-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091614-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-12-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091614-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-12-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091614-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-12-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091614-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-12-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091614-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-12-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091614-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-12-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091614-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2012-12-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091614-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2012-12-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091614-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2012-12-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091614-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2012-12-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091614-001 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2012-12-26 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 55150-124-99 Nafcillin 1 in 1 BOX INJECTION, POWDER, FOR SOLUTION 1 14 55150-124-99 Nafcillin 100 mL in 1 VIAL, PHARMACY BULK PACKAGE INJECTION, POWDER, FOR SOLUTION 100 14 55150-124-09 Nafcillin 100 mL in 1 VIAL, PHARMACY BULK PACKAGE INJECTION, POWDER, FOR SOLUTION 100 7 55150-124-09 Nafcillin 1 in 1 BOX INJECTION, POWDER, FOR SOLUTION 1 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NAFCILLIN SODIUM ACTIVE INGREDIENT 49G3001BCK NAFCILLIN (NAFCILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [AUROMEDICS PHARMA LLC] 5 NAFCILLIN ACTIVE MOIETY 4CNZ27M7RV NAFCILLIN (NAFCILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [AUROMEDICS PHARMA LLC] 5 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR NAFCILLIN (NAFCILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [AUROMEDICS PHARMA LLC] 5 NAFCILLIN SODIUM ACTIVE INGREDIENT 49G3001BCK NAFCILLIN (NAFCILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [AUROMEDICS PHARMA LLC] 1 NAFCILLIN ACTIVE MOIETY 4CNZ27M7RV NAFCILLIN (NAFCILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [AUROMEDICS PHARMA LLC] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR NAFCILLIN (NAFCILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [AUROMEDICS PHARMA LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55150-124 NAFCILLIN (NAFCILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [EUGIA US LLC] 13 Current NDC, Legacy NDC, 2 package rows 20240203_8ec288e6-4d7f-4fea-a5ab-f9f337ebaa86.zip 55150-124 NAFCILLIN (NAFCILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [EUGIA US LLC] 6 Current NDC, Legacy NDC, 2 package rows 20230126_0f21384c-0f82-4d99-a05c-6773d1ee4bcf.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 · 2 matching rows.
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 55150-124-09 55150012409 1 VIAL, PHARMACY BULK PACKAGE in 1 BOX (55150-124-09) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE 2012-12-26 0000-00-00 No No Current 55150-124-99 55150012499 1 VIAL, PHARMACY BULK PACKAGE in 1 BOX (55150-124-99) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE 2012-12-26 0000-00-00 No No Current