Home NDC 43858-116 Nafcillin
Product NDC 43858-116
11-digit product format 438580116
Labeler code 43858
Product ID 43858-116_29d5b646-b13e-4bc5-8575-5fa6d5c6aeeb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nafcillin
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Sandoz GmbH
Application ANDA062527
Marketing category ANDA
Marketing start 1984-08-02
Marketing end 0000-00-00
Substance NAFCILLIN SODIUM
Active strength 1 g/1
Pharmacologic classes Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A062527-001 NAFCILLIN SODIUM NAFCILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 1984-08-02 A062527-002 NAFCILLIN SODIUM NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1984-08-02 A062527-003 NAFCILLIN SODIUM NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 1984-08-02 A062527-004 NAFCILLIN SODIUM NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION 1984-08-02
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 5 · 176 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 2026-10-15 13:18:30 2026-09 A062527-001 NAFCILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 1984-08-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 A062527-002 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1984-08-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 A062527-003 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 1984-08-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 A062527-004 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION 1984-08-02 c2088c7a36db…2026-09-14 22:38:34 2026-08 A062527-001 NAFCILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 1984-08-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A062527-002 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1984-08-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A062527-003 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 1984-08-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A062527-004 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION 1984-08-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A062527-001 NAFCILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 1984-08-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A062527-002 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1984-08-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A062527-003 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 1984-08-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A062527-004 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION 1984-08-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A062527-001 NAFCILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 1984-08-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A062527-002 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1984-08-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A062527-003 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 1984-08-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A062527-004 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION 1984-08-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062527-001 NAFCILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 1984-08-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062527-002 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1984-08-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062527-003 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 1984-08-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062527-004 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION 1984-08-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062527-001 NAFCILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 1984-08-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A062527-002 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1984-08-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A062527-003 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 1984-08-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A062527-004 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION 1984-08-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062527-001 NAFCILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 1984-08-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062527-002 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1984-08-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062527-003 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 1984-08-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062527-004 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION 1984-08-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062527-001 NAFCILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 1984-08-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062527-002 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1984-08-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062527-003 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 1984-08-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062527-004 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION 1984-08-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062527-001 NAFCILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 1984-08-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062527-002 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1984-08-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062527-003 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 1984-08-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062527-004 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION 1984-08-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062527-001 NAFCILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 1984-08-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062527-002 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1984-08-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062527-003 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 1984-08-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062527-004 NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION 1984-08-02 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 54 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.