Home NDC 83270-309 NAFCILLIN SODIUM
Product NDC 83270-309
11-digit product format 832700309
Labeler code 83270
Product ID 83270-309_4c94ba3a-3e85-06b7-e063-6394a90a7034
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name NAFCILLIN SODIUM
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler ONESOURCE SPECIALTY PHARMA LIMITED
Application ANDA200002
Marketing category ANDA
Marketing start 2026-02-20
Substance NAFCILLIN SODIUM
Active strength 1 g/1
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 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 A200002-001 NAFCILLIN SODIUM NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 A200002-002 NAFCILLIN SODIUM NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07
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 A200002-001 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200002-002 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200002-001 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200002-002 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200002-001 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200002-002 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200002-001 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200002-002 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200002-001 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200002-002 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200002-001 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200002-002 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200002-001 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200002-002 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200002-001 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200002-002 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200002-001 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200002-002 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200002-001 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200002-002 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200002-001 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A200002-002 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200002-001 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200002-002 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200002-001 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200002-002 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200002-001 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200002-002 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200002-001 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A200002-002 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200002-001 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2014-04-07 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200002-002 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2014-04-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200002-001 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2014-04-07 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A200002-002 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2014-04-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200002-001 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2014-04-07 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A200002-002 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2014-04-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200002-001 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2014-04-07 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A200002-002 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2014-04-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A200002-001 NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2014-04-07 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A200002-002 NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2014-04-07 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
Additional Listing Data#
Finished product Yes
Brand name base NAFCILLIN SODIUM
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NAFCILLIN SODIUM 1 g/1
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 83270-309-10 NAFCILLIN SODIUM 10 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 10 2 83270-309-10 NAFCILLIN SODIUM 1 in 1 VIAL INJECTION, POWDER, FOR SOLUTION 1 2
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 Units Marketing start Sample Exclude flag Status 83270-309-10 83270030910 10 VIAL in 1 CARTON (83270-309-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL 10 vial 2026-02-20 No No Current