Home NDC 0338-1017-41 NAFCILLIN
Product NDC 0338-1017
Requested package NDC 0338-1017-41
11-digit product format 003381017
Labeler code 0338
Product ID 0338-1017_e6fa2f91-def8-4474-84ce-5085c73374fb
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
Marketing end 0000-00-00
Substance NAFCILLIN SODIUM
Active strength 1 g/50mL
Pharmacologic classes Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…
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 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 · 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 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…2022-03-09 01:35 UTC 2022-03 N050655-001 NALLPEN IN PLASTIC CONTAINER EQ 20MG BASE/ML INJECTABLE / INJECTION RLD, RS 1989-10-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N050655-002 NALLPEN IN PLASTIC CONTAINER EQ 2GM BASE/100ML INJECTABLE / INJECTION RLD, RS 1989-10-31 bb7c543d1eb4…
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0338-1017-41 NAFCILLIN 50 mL in 1 BAG INJECTION, SOLUTION 50 19
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0338-1017 NAFCILLIN INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] 19 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 0338-1017-41 00338101741 50 mL in 1 BAG (0338-1017-41) 50 ml 1989-10-31 0000-00-00 No No Current