Nafcillin

Product NDC
25021-141
11-digit product format
250210141
Labeler code
25021
Product ID
25021-141_9acd3c53-9e83-4462-b8cc-6299085640d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nafcillin sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA090580
Marketing category
ANDA
Marketing start
2012-10-25
Marketing end
0000-00-00
Substance
NAFCILLIN SODIUM
Active strength
10 g/100mL
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 productproduct25021-141DDiscontinued by firm2026-08-17
excluded packagepackage25021-14125021-141-99DDiscontinued 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 · 4 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 packagepackage25021-141-99d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage25021-141-99f5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090580-001NAFCILLIN SODIUMNAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2012-08-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A090580-001AP

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A090580-001NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2012-08-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090580-001NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2012-08-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090580-001NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2012-08-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A090580-001NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2012-08-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090580-001NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2012-08-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090580-001NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2012-08-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090580-001NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2012-08-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090580-001NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2012-08-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090580-001NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2012-08-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090580-001NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2012-08-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090580-001NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2012-08-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090580-001NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2012-08-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090580-001NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2012-08-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090580-001NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2012-08-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090580-001NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2012-08-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090580-001NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2012-08-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090580-001NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2012-08-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090580-001NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2012-08-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090580-001NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2012-08-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090580-001NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2012-08-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090580-001NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2012-08-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090580-001NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2012-08-2487673890dc5c…
2021-03-12 10:30 UTC2021-03A090580-001NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2012-08-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090580-001NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2012-08-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090580-001NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2012-08-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090580-001NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2012-08-243f01610625f2…
2019-09-15 20:21 UTC2019-09A090580-001NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2012-08-24b00525d2431f…
2019-07-19 19:46 UTC2019-07A090580-001NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2012-08-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090580-001NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2012-08-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090580-001NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2012-08-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090580-001NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2012-08-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090580-001NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2012-08-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090580-001NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2012-08-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090580-001NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2012-08-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090580-001NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2012-08-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A090580-001NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2012-08-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A090580-001NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2012-08-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090580-001NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2012-08-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090580-001NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2012-08-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090580-001NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2012-08-24e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A090580-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090580-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090580-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090580-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090580-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090580-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090580-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090580-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090580-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090580-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090580-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090580-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090580-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090580-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090580-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090580-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090580-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090580-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090580-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090580-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090580-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090580-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A090580-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090580-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090580-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090580-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A090580-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090580-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090580-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090580-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090580-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090580-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090580-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090580-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090580-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090580-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090580-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090580-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090580-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090580-001AP1e64feba35796…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
25021-141-992024-01-30C16284748780-11030e365-6ae5-111a-e063-dadaa90a10e2Nafcillin for Injection, USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-141-99EA - Each25021-141df326f4a-a422-4dc0-9a81-76568b84162512013-02-13

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-141NAFCILLIN (NAFCILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]13Legacy NDC20240724_5a501234-5e1c-441f-be97-97add6eabb13.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-141-992502101419910 BOTTLE in 1 CARTON (25021-141-99) > 100 mL in 1 BOTTLE10 bottle2012-10-250000-00-00NoNoCurrent