Home NDC 0338-1019 NAFCILLIN
Product NDC 0338-1019
11-digit product format 003381019
Labeler code 0338
Product ID 0338-1019_80c1285d-488f-4901-af11-b867ef156536
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name NAFCILLIN
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Baxter Healthcare Corporation
Application NDA050655
Marketing category NDA
Marketing start 1989-10-31
Substance NAFCILLIN SODIUM
Active strength 2 g/100mL
Pharmacologic classes Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N050655-001 NALLPEN IN PLASTIC CONTAINER NAFCILLIN SODIUM EQ 20MG BASE/ML INJECTABLE / INJECTION RLD 1989-10-31 N050655-002 NALLPEN IN PLASTIC CONTAINER NAFCILLIN SODIUM EQ 2GM BASE/100ML INJECTABLE / INJECTION RLD, RS 1989-10-31
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 · 86 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 2026-09-14 22:38:34 2026-08 N050655-001 NALLPEN IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD 1989-10-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N050655-002 NALLPEN IN PLASTIC CONTAINER EQ 2GM BASE/100ML INJECTABLE / INJECTION RLD, RS 1989-10-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 N050655-001 NALLPEN IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD 1989-10-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N050655-002 NALLPEN IN PLASTIC CONTAINER EQ 2GM BASE/100ML INJECTABLE / INJECTION RLD, RS 1989-10-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N050655-001 NALLPEN IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050655-002 NALLPEN IN PLASTIC CONTAINER EQ 2GM BASE/100ML INJECTABLE / INJECTION RLD, RS 1989-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050655-001 NALLPEN IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050655-002 NALLPEN IN PLASTIC CONTAINER EQ 2GM BASE/100ML INJECTABLE / INJECTION RLD, RS 1989-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050655-001 NALLPEN IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050655-002 NALLPEN IN PLASTIC CONTAINER EQ 2GM BASE/100ML INJECTABLE / INJECTION RLD, RS 1989-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050655-001 NALLPEN IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050655-002 NALLPEN IN PLASTIC CONTAINER EQ 2GM BASE/100ML INJECTABLE / INJECTION RLD, RS 1989-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050655-001 NALLPEN IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050655-002 NALLPEN IN PLASTIC CONTAINER EQ 2GM BASE/100ML INJECTABLE / INJECTION RLD, RS 1989-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050655-001 NALLPEN IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050655-002 NALLPEN IN PLASTIC CONTAINER EQ 2GM BASE/100ML INJECTABLE / INJECTION RLD, RS 1989-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050655-001 NALLPEN IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050655-002 NALLPEN IN PLASTIC CONTAINER EQ 2GM BASE/100ML INJECTABLE / INJECTION RLD, RS 1989-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050655-001 NALLPEN IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050655-002 NALLPEN IN PLASTIC CONTAINER EQ 2GM BASE/100ML INJECTABLE / INJECTION RLD, RS 1989-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050655-001 NALLPEN IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050655-002 NALLPEN IN PLASTIC CONTAINER EQ 2GM BASE/100ML INJECTABLE / INJECTION RLD, RS 1989-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050655-001 NALLPEN IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050655-002 NALLPEN IN PLASTIC CONTAINER EQ 2GM BASE/100ML INJECTABLE / INJECTION RLD, RS 1989-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050655-001 NALLPEN IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050655-002 NALLPEN IN PLASTIC CONTAINER EQ 2GM BASE/100ML INJECTABLE / INJECTION RLD, RS 1989-10-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050655-001 NALLPEN IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050655-002 NALLPEN IN PLASTIC CONTAINER EQ 2GM BASE/100ML INJECTABLE / INJECTION RLD, RS 1989-10-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050655-001 NALLPEN IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050655-002 NALLPEN IN PLASTIC CONTAINER EQ 2GM BASE/100ML INJECTABLE / INJECTION RLD, RS 1989-10-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050655-001 NALLPEN IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N050655-002 NALLPEN IN PLASTIC CONTAINER EQ 2GM BASE/100ML INJECTABLE / INJECTION RLD, RS 1989-10-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050655-001 NALLPEN IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050655-002 NALLPEN IN PLASTIC CONTAINER EQ 2GM BASE/100ML INJECTABLE / INJECTION RLD, RS 1989-10-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050655-001 NALLPEN IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N050655-002 NALLPEN IN PLASTIC CONTAINER EQ 2GM BASE/100ML INJECTABLE / INJECTION RLD, RS 1989-10-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050655-001 NALLPEN IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N050655-002 NALLPEN IN PLASTIC CONTAINER EQ 2GM BASE/100ML INJECTABLE / INJECTION RLD, RS 1989-10-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050655-001 NALLPEN IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050655-002 NALLPEN IN PLASTIC CONTAINER EQ 2GM BASE/100ML INJECTABLE / INJECTION RLD, RS 1989-10-31 74a2ff9319b5…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base NAFCILLIN
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NAFCILLIN SODIUM 2 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 · 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 0338-1019-48 NAFCILLIN 100 mL in 1 BAG INJECTION, SOLUTION 100 19
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0338-1019 NAFCILLIN INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] 19 Current NDC, Legacy NDC, 1 package rows 20250502_cd2d18c5-95a2-4fb4-bd8b-b5d39e2da416.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 0338-1019-48 00338101948 100 mL in 1 BAG (0338-1019-48) 100 ml 1989-10-31 0000-00-00 No No Current