Home NDC 72603-453 Nafcillin
Product NDC 72603-453
11-digit product format 726030453
Labeler code 72603
Product ID 72603-453_ada50f84-5fb6-480b-a385-bb95d1181ce7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nafcillin Sodium
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler NorthStar Rx, LLC
Application ANDA090002
Marketing category ANDA
Marketing start 2024-07-01
Substance NAFCILLIN SODIUM
Active strength 2 g/8mL
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090002-001 NAFCILLIN SODIUM NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30 A090002-002 NAFCILLIN SODIUM NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 84 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 A090002-001 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090002-002 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090002-001 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090002-002 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090002-001 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090002-002 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090002-001 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090002-002 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090002-001 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090002-002 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090002-001 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090002-002 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090002-001 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090002-002 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090002-001 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090002-002 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090002-001 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090002-002 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090002-001 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090002-002 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090002-001 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090002-002 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090002-001 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090002-002 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090002-001 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090002-002 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090002-001 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090002-002 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090002-001 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090002-002 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090002-001 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090002-002 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090002-001 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090002-002 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090002-001 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090002-002 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090002-001 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090002-002 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090002-001 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A090002-002 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2011-06-30 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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 2 g/8mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1721458 Internal RxNorm lookup 1721460 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 72603-453-01 Nafcillin 1 in 1 BOX INJECTION, POWDER, FOR SOLUTION 1 4 72603-453-01 Nafcillin 8 mL in 1 VIAL INJECTION, POWDER, FOR SOLUTION 8 4 72603-453-10 Nafcillin 8 mL in 1 VIAL INJECTION, POWDER, FOR SOLUTION 8 4 72603-453-10 Nafcillin 10 in 1 BOX INJECTION, POWDER, FOR SOLUTION 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72603-453 NAFCILLIN (NAFCILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [NORTHSTAR RX, LLC] 4 Current NDC, 4 package rows 20240712_ae5fb012-4012-4063-b2e4-f1f927c6bf74.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72603-453-01 72603045301 1 VIAL in 1 BOX (72603-453-01) / 8 mL in 1 VIAL 1 vial 2024-07-01 No No Current 72603-453-10 72603045310 10 VIAL in 1 BOX (72603-453-10) / 8 mL in 1 VIAL 10 vial 2024-07-01 No No Current