Nafcillin Sodium

Product NDC
0781-9224
11-digit product format
007819224
Labeler code
0781
Product ID
0781-9224_83fc3560-c9bf-47e6-836a-416ed2305259
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nafcillin Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Sandoz Inc
Application
ANDA062732
Marketing category
ANDA
Marketing start
1986-12-23
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
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0781-9224DDiscontinued by firm2026-08-17
excluded packagepackage0781-92240781-9224-92DDiscontinued by firm2026-08-17

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0781-9224-92d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-9224-92f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-9224-922ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-9224-92a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-9224-92cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-9224-92cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-9224-92302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-9224-92ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-9224-920efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-9224-92ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-9224-92367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-9224-92557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A062732-001NAFCILLIN SODIUMNAFCILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-12-23
A062732-002NAFCILLIN SODIUMNAFCILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1986-12-23

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A062732-001NAFCILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-12-23caaa826d4ba7…
2026-08-18 06:07:402026-07A062732-002NAFCILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1986-12-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A062732-001NAFCILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-12-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062732-002NAFCILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1986-12-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062732-001NAFCILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-12-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062732-002NAFCILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1986-12-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A062732-001NAFCILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-12-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062732-002NAFCILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1986-12-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062732-001NAFCILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-12-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062732-002NAFCILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1986-12-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062732-001NAFCILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-12-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062732-002NAFCILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1986-12-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062732-001NAFCILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-12-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062732-002NAFCILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1986-12-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062732-001NAFCILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-12-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062732-002NAFCILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1986-12-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062732-001NAFCILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-12-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062732-002NAFCILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1986-12-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062732-001NAFCILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-12-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062732-002NAFCILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1986-12-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062732-001NAFCILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-12-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A062732-002NAFCILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1986-12-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062732-001NAFCILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-12-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062732-002NAFCILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1986-12-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062732-001NAFCILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-12-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062732-002NAFCILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1986-12-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062732-001NAFCILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-12-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062732-002NAFCILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1986-12-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062732-001NAFCILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-12-238072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062732-002NAFCILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1986-12-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062732-001NAFCILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS1986-12-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062732-002NAFCILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRS1986-12-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062732-001NAFCILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS1986-12-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062732-002NAFCILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRS1986-12-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062732-001NAFCILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS1986-12-234b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062732-002NAFCILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRS1986-12-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062732-001NAFCILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS1986-12-2374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062732-002NAFCILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRS1986-12-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062732-001NAFCILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS1986-12-23bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062732-002NAFCILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRS1986-12-23bb7c543d1eb4…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062732-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062732-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062732-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062732-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062732-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062732-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062732-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062732-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062732-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062732-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062732-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A062732-002AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062732-001AP187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062732-002AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A062732-001AP15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A062732-002AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A062732-001AP18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A062732-002AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A062732-001AP1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A062732-002AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A062732-001AP13f01610625f2…
2019-12-14 00:12 UTC2019-12A062732-002AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A062732-001AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09A062732-002AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A062732-001AP1ea99ee380514…
2019-07-19 19:46 UTC2019-07A062732-002AP1ea99ee380514…
2023-01-26 05:58 UTC2023-01A062732-001AP13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A062732-002AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A062732-001AP13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A062732-002AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A062732-001AP1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A062732-002AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A062732-001AP1e64feba35796…
2022-09-29 23:25 UTC2022-09A062732-002AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A062732-001AP1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A062732-002AP1cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-9224-15EA - Each0781-922467c3b4f3-ddec-4e1b-ab84-ba8e4467ed8912012-07-24
0781-9224-92EA - Each0781-922425644610-246a-49f3-97d1-566f3099a7ea12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAFCILLIN SODIUMACTIVE INGREDIENT49G3001BCKNAFCILLIN SODIUM INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]14
NAFCILLINACTIVE MOIETY4CNZ27M7RVNAFCILLIN SODIUM INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]14
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRNAFCILLIN SODIUM INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-9224-920078192249210 VIAL, PATENT DELIVERY SYSTEM in 1 PACKAGE (0781-9224-92) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PATENT DELIVERY SYSTEM (0781-9224-15) 2005-09-230000-00-00NoNoCurrent