Ampicillin

Product NDC
0409-3720
11-digit product format
004093720
Labeler code
0409
Product ID
0409-3720_c94b9c81-8266-4b5a-85f6-9c6d7a4e1393
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ampicillin sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hospira, Inc
Application
ANDA061395
Marketing category
ANDA
Marketing start
2017-08-01
Marketing end
2024-02-29
Substance
AMPICILLIN SODIUM
Active strength
2 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 productproduct0409-3720DDiscontinued by firm2026-08-17
excluded packagepackage0409-37200409-3720-01DDiscontinued 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 · 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 packagepackage0409-3720-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0409-3720-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0409-3720-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0409-3720-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0409-3720-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0409-3720-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0409-3720-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0409-3720-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0409-3720-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0409-3720-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0409-3720-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0409-3720-01557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A061395-001AMPICILLIN SODIUMAMPICILLIN SODIUMEQ 125MG BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 1982
A061395-002AMPICILLIN SODIUMAMPICILLIN SODIUMEQ 250MG BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 1982
A061395-003AMPICILLIN SODIUMAMPICILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 1982
A061395-004AMPICILLIN SODIUMAMPICILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 1982
A061395-005AMPICILLIN SODIUMAMPICILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 1982
A061395-006AMPICILLIN SODIUMAMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A061395-001AP
A061395-002AP
A061395-003AP
A061395-004AP
A061395-005AP
A061395-006AP

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 7 · 252 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A061395-001AMPICILLIN SODIUMEQ 125MG BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07A061395-002AMPICILLIN SODIUMEQ 250MG BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07A061395-003AMPICILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07A061395-004AMPICILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07A061395-005AMPICILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07A061395-006AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A061395-001AMPICILLIN SODIUMEQ 125MG BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A061395-002AMPICILLIN SODIUMEQ 250MG BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A061395-003AMPICILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A061395-004AMPICILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A061395-005AMPICILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A061395-006AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061395-001AMPICILLIN SODIUMEQ 125MG BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061395-002AMPICILLIN SODIUMEQ 250MG BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061395-003AMPICILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061395-004AMPICILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061395-005AMPICILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061395-006AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A061395-001AMPICILLIN SODIUMEQ 125MG BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A061395-002AMPICILLIN SODIUMEQ 250MG BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A061395-003AMPICILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A061395-004AMPICILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A061395-005AMPICILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A061395-006AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061395-001AMPICILLIN SODIUMEQ 125MG BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061395-002AMPICILLIN SODIUMEQ 250MG BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061395-003AMPICILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061395-004AMPICILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061395-005AMPICILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061395-006AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061395-001AMPICILLIN SODIUMEQ 125MG BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061395-002AMPICILLIN SODIUMEQ 250MG BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061395-003AMPICILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061395-004AMPICILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061395-005AMPICILLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061395-006AMPICILLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061395-001AMPICILLIN SODIUMEQ 125MG BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061395-002AMPICILLIN SODIUMEQ 250MG BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061395-003AMPICILLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061395-004AMPICILLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS, Approved before 198203ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 252 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A061395-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A061395-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A061395-003AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A061395-004AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A061395-005AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A061395-006AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A061395-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A061395-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A061395-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A061395-004AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A061395-005AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A061395-006AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061395-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061395-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061395-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061395-004AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061395-005AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061395-006AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A061395-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A061395-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A061395-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A061395-004AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A061395-005AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A061395-006AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061395-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061395-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061395-003AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061395-004AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061395-005AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061395-006AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061395-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061395-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061395-003AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061395-004AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061395-005AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061395-006AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061395-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061395-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061395-003AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061395-004AP103ed91905a0d…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-3720-01EA - Each0409-372073c01d7d-62bb-452c-bea7-2bc974034a0912017-09-11
0409-3720-10EA - Each0409-372014e80081-58dd-49d8-8093-5e4608872bdb12017-09-11

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmpicillinAMPICILLIN SODIUMSandoz Inc64a04e8c-8f78-46b3-8f45-56ef225a4f742025-02-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 061395
application number: ANDA061395
AmpicillinAMPICILLIN SODIUMSandoz Incc2908a44-1da4-4885-ae5a-23f69189d91a2024-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 061395
application number: ANDA061395
AmpicillinAMPICILLIN SODIUMSandoz Incb371e1a5-1fef-4df2-8940-c4fc02b9e2f02024-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 061395
application number: ANDA061395
AmpicillinAMPICILLIN SODIUMSandoz Inc5308ddfa-4a5b-4f7b-83ce-9d1b528e050d2024-05-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 061395
application number: ANDA061395
AmpicillinAMPICILLIN SODIUMSandoz Inc6632a5bd-45f1-422f-80b0-46e5a628969a2024-05-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 061395
application number: ANDA061395

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0409-3720-010040937200110 VIAL, GLASS in 1 PACKAGE (0409-3720-01) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (0409-3720-10) 2017-08-010000-00-00NoNoCurrent