FDA.reportPublic FDA data

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 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A062527-001NAFCILLIN SODIUMNAFCILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1984-08-02
A062527-002NAFCILLIN SODIUMNAFCILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1984-08-02
A062527-003NAFCILLIN SODIUMNAFCILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1984-08-02
A062527-004NAFCILLIN SODIUMNAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTION1984-08-02

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A062527-001NAFCILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1984-08-02caaa826d4ba7…
2026-08-18 06:07:402026-07A062527-002NAFCILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1984-08-02caaa826d4ba7…
2026-08-18 06:07:402026-07A062527-003NAFCILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1984-08-02caaa826d4ba7…
2026-08-18 06:07:402026-07A062527-004NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTION1984-08-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A062527-001NAFCILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1984-08-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062527-002NAFCILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1984-08-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062527-003NAFCILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1984-08-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062527-004NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTION1984-08-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062527-001NAFCILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1984-08-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062527-002NAFCILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1984-08-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062527-003NAFCILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1984-08-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062527-004NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTION1984-08-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A062527-001NAFCILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1984-08-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062527-002NAFCILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1984-08-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062527-003NAFCILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1984-08-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062527-004NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTION1984-08-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062527-001NAFCILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1984-08-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062527-002NAFCILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1984-08-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062527-003NAFCILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1984-08-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062527-004NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTION1984-08-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062527-001NAFCILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1984-08-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062527-002NAFCILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1984-08-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062527-003NAFCILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1984-08-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062527-004NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTION1984-08-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062527-001NAFCILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1984-08-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062527-002NAFCILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1984-08-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062527-003NAFCILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1984-08-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062527-004NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTION1984-08-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062527-001NAFCILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1984-08-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062527-002NAFCILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1984-08-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062527-003NAFCILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1984-08-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062527-004NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTION1984-08-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062527-001NAFCILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1984-08-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062527-002NAFCILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1984-08-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062527-003NAFCILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1984-08-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062527-004NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTION1984-08-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062527-001NAFCILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION1984-08-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062527-002NAFCILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION1984-08-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062527-003NAFCILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION1984-08-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062527-004NAFCILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTION1984-08-02d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062527-002AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062527-003AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062527-004AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062527-002AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062527-003AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062527-004AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062527-002AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062527-003AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062527-004AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062527-002AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062527-003AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062527-004AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062527-002AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062527-003AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062527-004AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062527-002AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A062527-003AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A062527-004AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062527-002AP187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062527-003AP187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062527-004AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A062527-002AP15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A062527-003AP15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A062527-004AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A062527-002AP18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A062527-003AP18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A062527-004AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A062527-002AP1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A062527-003AP1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A062527-004AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A062527-002AP13f01610625f2…
2019-12-14 00:12 UTC2019-12A062527-003AP13f01610625f2…
2019-12-14 00:12 UTC2019-12A062527-004AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A062527-002AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09A062527-003AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09A062527-004AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A062527-002AP1ea99ee380514…
2019-07-19 19:46 UTC2019-07A062527-003AP1ea99ee380514…
2019-07-19 19:46 UTC2019-07A062527-004AP1ea99ee380514…
2023-01-26 05:58 UTC2023-01A062527-002AP13bdfa0b2c4d7…