Application 065499

Type
ANDA
Sponsor
AUROBINDO PHARMA

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
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
ndc (product): 0404-9818
AmpicillinAMPICILLIN SODIUMEugia US LLCb7bf2897-8272-4c7d-84e9-6fbba0ea63fa2025-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065499
application number: ANDA065499
ndc (product): 55150-113
ndc (product): 55150-111
ndc (product): 55150-112
ndc (product): 55150-114
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
ndc (product): 51662-1560
AmpicillinAMPICILLIN SODIUMMedical Purchasing Solutions, LLC690f1986-6da9-4787-e053-2a91aa0a26442023-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065499
application number: ANDA065499
ndc (product): 71872-7086
AmpicillinAMPICILLIN SODIUMMedical Purchasing Solutions, LLC70c022b0-ac9a-409b-e053-2a91aa0a757e2023-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065499
application number: ANDA065499
ndc (product): 71872-7139

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 38 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9816AMPICILLINAMPICILLIN SODIUMHenry Schein, Inc.ANDACurrent
0404-9816AMPICILLINAMPICILLIN SODIUMHenry Schein, Inc.ANDACurrent
0404-9818AMPICILLINAMPICILLIN SODIUMHenry Schein, Inc.ANDACurrent
0404-9818AMPICILLINAMPICILLIN SODIUMHenry Schein, Inc.ANDACurrent
51662-1560AMPICILLINAMPICILLINHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1560AMPICILLINAMPICILLINHF Acquisition Co LLC, DBA HealthFirstANDACurrent
52584-082AMPICILLINAMPICILLIN SODIUMGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-082AMPICILLINAMPICILLIN SODIUMGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-082AMPICILLINAMPICILLIN SODIUMGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-114AMPICILLINAMPICILLIN SODIUMGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-114AMPICILLINAMPICILLIN SODIUMGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-114AMPICILLINAMPICILLIN SODIUMGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-114AMPICILLINAMPICILLIN SODIUMGeneral Injectables and Vaccines, Inc.ANDACurrent
55150-111AmpicillinAmpicillin SodiumAuroMedics Pharma LLCANDACurrent
55150-111AmpicillinAmpicillin SodiumAuroMedics Pharma LLCANDACurrent
55150-111AmpicillinAmpicillin SodiumAuroMedics Pharma LLCANDACurrent
55150-111AmpicillinAmpicillin SodiumAuroMedics Pharma LLCANDACurrent
55150-111AmpicillinAmpicillin SodiumAuroMedics Pharma LLCANDACurrent
55150-112AmpicillinAmpicillin SodiumAuroMedics Pharma LLCANDACurrent
55150-112AmpicillinAmpicillin SodiumAuroMedics Pharma LLCANDACurrent
55150-112AmpicillinAmpicillin SodiumAuroMedics Pharma LLCANDACurrent
55150-112AmpicillinAmpicillin SodiumAuroMedics Pharma LLCANDACurrent
55150-112AmpicillinAmpicillin SodiumAuroMedics Pharma LLCANDACurrent
55150-113AmpicillinAmpicillin SodiumAuroMedics Pharma LLCANDACurrent
55150-113AmpicillinAmpicillin SodiumAuroMedics Pharma LLCANDACurrent
55150-113AmpicillinAmpicillin SodiumAuroMedics Pharma LLCANDACurrent
55150-113AmpicillinAmpicillin SodiumAuroMedics Pharma LLCANDACurrent
55150-113AmpicillinAmpicillin SodiumAuroMedics Pharma LLCANDACurrent
55150-114AmpicillinAmpicillin SodiumAuroMedics Pharma LLCANDACurrent
55150-114AmpicillinAmpicillin SodiumAuroMedics Pharma LLCANDACurrent
55150-114AmpicillinAmpicillin SodiumAuroMedics Pharma LLCANDACurrent
55150-114AmpicillinAmpicillin SodiumAuroMedics Pharma LLCANDACurrent
55150-114AmpicillinAmpicillin SodiumAuroMedics Pharma LLCANDACurrent
71872-7086AmpicillinAmpicillin SodiumMedical Purchasing Solutions, LLCANDACurrent
71872-7086AmpicillinAmpicillin SodiumMedical Purchasing Solutions, LLCANDACurrent
71872-7086AmpicillinAmpicillin SodiumMedical Purchasing Solutions, LLCANDACurrent
71872-7139AmpicillinAmpicillin SodiumMedical Purchasing Solutions, LLCANDACurrent
71872-7139AmpicillinAmpicillin SodiumMedical Purchasing Solutions, LLCANDACurrent