AMPICILLIN

Product NDC
52584-082
11-digit product format
525840082
Labeler code
52584
Product ID
52584-082_f95e0226-4a5c-45cc-9b8e-0b26c6b7f5bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMPICILLIN SODIUM
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
General Injectables and Vaccines, Inc.
Application
ANDA065499
Marketing category
ANDA
Marketing start
2018-10-10
Marketing end
2023-10-31
Substance
AMPICILLIN SODIUM
Active strength
1 g/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct52584-082DDiscontinued by firm2026-08-10
excluded packagepackage52584-08252584-082-10DDiscontinued by firm2026-08-10

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 packagepackage52584-082-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52584-082-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52584-082-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52584-082-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52584-082-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52584-082-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52584-082-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52584-082-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52584-082-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52584-082-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52584-082-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52584-082-10557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065499-001AMPICILLIN SODIUMAMPICILLIN SODIUMEQ 125MG BASE/VIALINJECTABLE / INJECTION2010-08-17
A065499-002AMPICILLIN SODIUMAMPICILLIN SODIUMEQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2010-08-17
A065499-003AMPICILLIN SODIUMAMPICILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2010-08-17
A065499-004AMPICILLIN SODIUMAMPICILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2010-08-17
A065499-005AMPICILLIN SODIUMAMPICILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2010-08-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A065499-002AP
A065499-003AP
A065499-004AP
A065499-005AP

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 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065499-001AMPICILLIN SODIUMEQ 125MG BASE/VIALINJECTABLE / INJECTION2010-08-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065499-002AMPICILLIN SODIUMEQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2010-08-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065499-003AMPICILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2010-08-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065499-004AMPICILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2010-08-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065499-005AMPICILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2010-08-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065499-001AMPICILLIN SODIUMEQ 125MG BASE/VIALINJECTABLE / INJECTION2010-08-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065499-002AMPICILLIN SODIUMEQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2010-08-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065499-003AMPICILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2010-08-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065499-004AMPICILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2010-08-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065499-005AMPICILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2010-08-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A065499-001AMPICILLIN SODIUMEQ 125MG BASE/VIALINJECTABLE / INJECTION2010-08-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065499-002AMPICILLIN SODIUMEQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2010-08-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065499-003AMPICILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2010-08-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065499-004AMPICILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2010-08-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065499-005AMPICILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2010-08-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065499-001AMPICILLIN SODIUMEQ 125MG BASE/VIALINJECTABLE / INJECTION2010-08-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065499-002AMPICILLIN SODIUMEQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2010-08-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065499-003AMPICILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2010-08-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065499-004AMPICILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2010-08-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065499-005AMPICILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2010-08-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065499-001AMPICILLIN SODIUMEQ 125MG BASE/VIALINJECTABLE / INJECTION2010-08-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065499-002AMPICILLIN SODIUMEQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2010-08-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065499-003AMPICILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2010-08-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065499-004AMPICILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2010-08-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065499-005AMPICILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2010-08-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065499-001AMPICILLIN SODIUMEQ 125MG BASE/VIALINJECTABLE / INJECTION2010-08-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065499-002AMPICILLIN SODIUMEQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2010-08-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065499-003AMPICILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2010-08-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065499-004AMPICILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2010-08-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065499-005AMPICILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2010-08-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065499-001AMPICILLIN SODIUMEQ 125MG BASE/VIALINJECTABLE / INJECTION2010-08-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065499-002AMPICILLIN SODIUMEQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2010-08-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065499-003AMPICILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2010-08-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065499-004AMPICILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2010-08-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065499-005AMPICILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2010-08-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065499-001AMPICILLIN SODIUMEQ 125MG BASE/VIALINJECTABLE / INJECTION2010-08-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065499-002AMPICILLIN SODIUMEQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2010-08-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065499-003AMPICILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2010-08-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065499-004AMPICILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2010-08-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065499-005AMPICILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2010-08-175bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065499-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065499-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065499-004AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065499-005AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065499-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065499-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065499-004AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065499-005AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065499-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065499-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065499-004AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065499-005AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065499-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065499-003AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065499-004AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065499-005AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065499-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065499-003AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065499-004AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065499-005AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065499-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065499-003AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065499-004AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065499-005AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065499-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065499-003AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065499-004AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065499-005AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065499-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065499-003AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065499-004AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065499-005AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065499-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065499-003AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065499-004AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065499-005AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065499-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065499-003AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065499-004AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065499-005AP1d06236e962d9…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMPICILLINAMPICILLIN SODIUMHenry Schein, Inc.78988f6a-a73b-4d3b-9a76-d61a748c3c162026-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065499
application number: ANDA065499
AMPICILLINAMPICILLIN SODIUMHenry Schein, Inc.06ca924c-5f3a-4924-90f4-5ba623daaa0e2026-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065499
application number: ANDA065499
AmpicillinAMPICILLIN SODIUMEugia US LLCb7bf2897-8272-4c7d-84e9-6fbba0ea63fa2025-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065499
application number: ANDA065499
AmpicillinAMPICILLIN SODIUMProPharma Distribution364b1db9-e523-7bae-e063-6294a90a651d2025-07-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065499
application number: ANDA065499
AMPICILLINAMPICILLINHF Acquisition Co LLC, DBA HealthFirste51db6a3-027a-6e24-e053-2a95a90a15872024-01-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065499
application number: ANDA065499
AmpicillinAMPICILLIN SODIUMMedical Purchasing Solutions, LLC690f1986-6da9-4787-e053-2a91aa0a26442023-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065499
application number: ANDA065499
AmpicillinAMPICILLIN SODIUMMedical Purchasing Solutions, LLC70c022b0-ac9a-409b-e053-2a91aa0a757e2023-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065499
application number: ANDA065499

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52584-082-10525840082101 VIAL in 1 BAG (52584-082-10) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL1 vial2018-10-100000-00-00NoNoCurrent