Application 090583

Type
ANDA
Sponsor
SAGENT PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMPICILLIN SODIUMAMPICILLIN SODIUMINJECTABLE;INJECTIONEQ 125MG BASE/VIALNoNo
002AMPICILLIN SODIUMAMPICILLIN SODIUMINJECTABLE;INJECTIONEQ 250MG BASE/VIALNoNo
003AMPICILLIN SODIUMAMPICILLIN SODIUMINJECTABLE;INJECTIONEQ 500MG BASE/VIALNoNo
004AMPICILLIN SODIUMAMPICILLIN SODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIALNoNo
005AMPICILLIN SODIUMAMPICILLIN SODIUMINJECTABLE;INJECTIONEQ 2GM BASE/VIALNoNo

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
A090583-001AMPICILLIN SODIUMAMPICILLIN SODIUMEQ 125MG BASE/VIALINJECTABLE / INJECTIONAP2015-11-27
A090583-002AMPICILLIN SODIUMAMPICILLIN SODIUMEQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2015-11-27
A090583-003AMPICILLIN SODIUMAMPICILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2015-11-27
A090583-004AMPICILLIN SODIUMAMPICILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2015-11-27
A090583-005AMPICILLIN SODIUMAMPICILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2015-11-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A090583-001AP
A090583-002AP
A090583-003AP
A090583-004AP
A090583-005AP

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 UTC2026-02A090583-001AMPICILLIN SODIUMEQ 125MG BASE/VIALINJECTABLE / INJECTIONAP2015-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090583-002AMPICILLIN SODIUMEQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2015-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090583-003AMPICILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2015-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090583-004AMPICILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2015-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090583-005AMPICILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2015-11-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090583-001AMPICILLIN SODIUMEQ 125MG BASE/VIALINJECTABLE / INJECTIONAP2015-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090583-002AMPICILLIN SODIUMEQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2015-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090583-003AMPICILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2015-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090583-004AMPICILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2015-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090583-005AMPICILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2015-11-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A090583-001AMPICILLIN SODIUMEQ 125MG BASE/VIALINJECTABLE / INJECTIONAP2015-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090583-002AMPICILLIN SODIUMEQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2015-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090583-003AMPICILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2015-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090583-004AMPICILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2015-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090583-005AMPICILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2015-11-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090583-001AMPICILLIN SODIUMEQ 125MG BASE/VIALINJECTABLE / INJECTIONAP2015-11-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090583-002AMPICILLIN SODIUMEQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2015-11-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090583-003AMPICILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2015-11-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090583-004AMPICILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2015-11-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090583-005AMPICILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2015-11-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090583-001AMPICILLIN SODIUMEQ 125MG BASE/VIALINJECTABLE / INJECTIONAP2015-11-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090583-002AMPICILLIN SODIUMEQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2015-11-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090583-003AMPICILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2015-11-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090583-004AMPICILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2015-11-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090583-005AMPICILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2015-11-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090583-001AMPICILLIN SODIUMEQ 125MG BASE/VIALINJECTABLE / INJECTIONAP2015-11-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090583-002AMPICILLIN SODIUMEQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2015-11-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090583-003AMPICILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2015-11-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090583-004AMPICILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2015-11-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090583-005AMPICILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2015-11-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090583-001AMPICILLIN SODIUMEQ 125MG BASE/VIALINJECTABLE / INJECTIONAP2015-11-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090583-002AMPICILLIN SODIUMEQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2015-11-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090583-003AMPICILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2015-11-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090583-004AMPICILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2015-11-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090583-005AMPICILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2015-11-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090583-001AMPICILLIN SODIUMEQ 125MG BASE/VIALINJECTABLE / INJECTIONAP2015-11-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090583-002AMPICILLIN SODIUMEQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2015-11-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090583-003AMPICILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2015-11-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090583-004AMPICILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2015-11-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090583-005AMPICILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2015-11-275bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090583-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090583-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090583-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090583-004AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090583-005AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090583-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090583-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090583-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090583-004AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090583-005AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090583-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090583-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090583-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090583-004AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090583-005AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090583-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090583-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090583-003AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090583-004AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090583-005AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090583-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090583-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090583-003AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090583-004AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090583-005AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090583-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090583-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090583-003AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090583-004AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090583-005AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090583-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090583-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090583-003AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090583-004AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090583-005AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090583-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090583-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090583-003AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090583-004AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090583-005AP15bbf6a4d5a75…

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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMPICILLINAMPICILLIN SODIUMHenry Schein, Inc.78988f6a-a73b-4d3b-9a76-d61a748c3c162026-07-31Warnings, Adverse reactionsName fallback
generic name: AMPICILLIN SODIUM
Ampicillin SodiumAMPICILLIN SODIUMSagent Pharmaceuticals5b3796dd-6f81-4999-ae2b-a13a727957292026-07-27Warnings, Adverse reactionsName fallback
brand name: Ampicillin Sodium
generic name: AMPICILLIN SODIUM
AMPICILLINAMPICILLIN SODIUMHenry Schein, Inc.06ca924c-5f3a-4924-90f4-5ba623daaa0e2026-04-30Warnings, Adverse reactionsName fallback
generic name: AMPICILLIN SODIUM
Ampicillin sodiumAMPICILLIN SODIUMMedical Purchasing Solutions, LLC402e7cc7-5ae8-c113-e063-6394a90aa54a2025-10-02Warnings, Adverse reactionsName fallback
brand name: Ampicillin sodium
generic name: AMPICILLIN SODIUM
AmpicillinAMPICILLIN SODIUMEugia US LLCb7bf2897-8272-4c7d-84e9-6fbba0ea63fa2025-08-14Warnings, Adverse reactionsName fallback
generic name: AMPICILLIN SODIUM
AmpicillinAMPICILLIN SODIUMEugia US LLC66146d45-0fe4-46b9-b2b1-b67c219088b72025-08-14Warnings, Adverse reactionsName fallback
generic name: AMPICILLIN SODIUM
AmpicillinAMPICILLINArmas Pharmaceuticals Inc.34e95c91-3767-493c-8716-38e61e7c66742025-07-31Warnings, Adverse reactionsName fallback
brand name: Ampicillin sodium
generic name: AMPICILLIN SODIUM
AmpicillinAMPICILLIN SODIUMProPharma Distribution364b1db9-e523-7bae-e063-6294a90a651d2025-07-18Warnings, Adverse reactionsName fallback
generic name: AMPICILLIN SODIUM
Ampicillin sodiumAMPICILLINCivica, Inc.2fd0f9fa-5b86-42f7-9a9f-767123638d392025-06-30Warnings, Adverse reactionsName fallback
brand name: Ampicillin sodium
generic name: AMPICILLIN SODIUM
AmpicillinAMPICILLIN SODIUMSandoz Inc67dd2930-8482-4da5-b663-b751aff18c612025-05-16Warnings, Adverse reactionsName fallback
generic name: AMPICILLIN SODIUM
AmpicillinAMPICILLIN SODIUMSandoz Inc64a04e8c-8f78-46b3-8f45-56ef225a4f742025-02-21Warnings, Adverse reactionsName fallback
generic name: AMPICILLIN SODIUM
AmpicillinAMPICILLIN SODIUMAvenacy Inc.19546563-50b7-4160-8cbe-f8e7079cba692025-02-01Warnings, Adverse reactionsName fallback
generic name: AMPICILLIN SODIUM
AmpicillinAMPICILLIN SODIUMAthenex Pharmaceutical Division, LLC.06b1c203-600c-4083-986a-d1d471b56e432025-01-28Warnings, Adverse reactionsName fallback
generic name: AMPICILLIN SODIUM
AmpicillinAMPICILLIN SODIUMSandoz Incc2908a44-1da4-4885-ae5a-23f69189d91a2024-10-31Warnings, Adverse reactionsName fallback
generic name: AMPICILLIN SODIUM
AmpicillinAMPICILLIN SODIUMSandoz Incb371e1a5-1fef-4df2-8940-c4fc02b9e2f02024-10-31Warnings, Adverse reactionsName fallback
generic name: AMPICILLIN SODIUM
AmpicillinAMPICILLIN SODIUMSandoz Inc5308ddfa-4a5b-4f7b-83ce-9d1b528e050d2024-05-09Warnings, Adverse reactionsName fallback
generic name: AMPICILLIN SODIUM
AmpicillinAMPICILLIN SODIUMSandoz Inc6632a5bd-45f1-422f-80b0-46e5a628969a2024-05-08Warnings, Adverse reactionsName fallback
generic name: AMPICILLIN SODIUM
AmpicillinAMPICILLIN SODIUMSandoz Incf77db491-31c4-4a7c-a114-0f3244c970902024-05-07Warnings, Adverse reactionsName fallback
generic name: AMPICILLIN SODIUM
AmpicillinAMPICILLIN SODIUMNorthStar Rx, LLC3b683547-48ac-48ca-8fd4-6866fd17be342024-02-23Warnings, Adverse reactionsName fallback
generic name: AMPICILLIN SODIUM
AmpicillinAMPICILLIN SODIUMNorthStar Rx, LLC6772d650-9814-49e4-a4ec-0b1a97b837d12024-02-22Warnings, Adverse reactionsName fallback
generic name: AMPICILLIN SODIUM

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
66794-220AmpicillinAmpicillinPiramal Critical Care IncANDACurrent
66794-220AmpicillinAmpicillinPiramal Critical Care IncANDACurrent
66794-220AmpicillinAmpicillinPiramal Critical Care IncANDACurrent
66794-220AmpicillinAmpicillinPiramal Critical Care IncANDACurrent
66794-220AmpicillinAmpicillinPiramal Critical Care IncANDACurrent
66794-221AmpicillinAmpicillinPiramal Critical Care IncANDACurrent
66794-221AmpicillinAmpicillinPiramal Critical Care IncANDACurrent
66794-221AmpicillinAmpicillinPiramal Critical Care IncANDACurrent
66794-221AmpicillinAmpicillinPiramal Critical Care IncANDACurrent
66794-221AmpicillinAmpicillinPiramal Critical Care IncANDACurrent
66794-222AmpicillinAmpicillinPiramal Critical Care IncANDACurrent
66794-222AmpicillinAmpicillinPiramal Critical Care IncANDACurrent
66794-222AmpicillinAmpicillinPiramal Critical Care IncANDACurrent
66794-222AmpicillinAmpicillinPiramal Critical Care IncANDACurrent
66794-222AmpicillinAmpicillinPiramal Critical Care IncANDACurrent
66794-223AmpicillinAmpicillinPiramal Critical Care IncANDACurrent
66794-223AmpicillinAmpicillinPiramal Critical Care IncANDACurrent
66794-223AmpicillinAmpicillinPiramal Critical Care IncANDACurrent
66794-223AmpicillinAmpicillinPiramal Critical Care IncANDACurrent
66794-223AmpicillinAmpicillinPiramal Critical Care IncANDACurrent
70594-084AmpicillinAMPICILLIN SODIUMXellia Pharmaceuticals USA LLCANDACurrent
70594-085AmpicillinAMPICILLIN SODIUMXellia Pharmaceuticals USA LLCANDACurrent
70594-086AmpicillinAMPICILLIN SODIUMXellia Pharmaceuticals USA LLCANDACurrent
70594-087AmpicillinAMPICILLIN SODIUMXellia Pharmaceuticals USA LLCANDACurrent
71872-7280AmpicillinAMPICILLIN SODIUMMedical Purchasing Solutions, LLCANDACurrent
71872-7286AmpicillinAMPICILLIN SODIUMMedical Purchasing Solutions, LLCANDACurrent