Home NDC 0781-9409 Ampicillin
Product NDC 0781-9409
11-digit product format 007819409
Labeler code 0781
Product ID 0781-9409_86e9a3cc-bc65-4d4f-916d-98c916588730
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ampicillin Sodium
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Sandoz Inc
Application ANDA061395
Marketing category ANDA
Marketing start 1971-03-03
Substance AMPICILLIN SODIUM
Active strength 10 g/1
Pharmacologic classes Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A061395-001 AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 A061395-002 AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 A061395-003 AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 A061395-004 AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 A061395-005 AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 A061395-006 AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A061395-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A061395-002 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A061395-003 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A061395-004 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A061395-005 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A061395-006 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A061395-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A061395-002 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A061395-003 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A061395-004 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A061395-005 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A061395-006 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A061395-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A061395-002 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A061395-003 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A061395-004 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A061395-005 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A061395-006 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A061395-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A061395-002 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A061395-003 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A061395-004 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A061395-005 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A061395-006 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A061395-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A061395-002 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A061395-003 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A061395-004 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A061395-005 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A061395-006 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A061395-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A061395-002 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A061395-003 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A061395-004 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A061395-005 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A061395-006 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A061395-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A061395-002 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A061395-003 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A061395-004 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 252 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ampicillin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMPICILLIN SODIUM 10 g/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination JFN36L5S8K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 789980 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0781-9409-46 Ampicillin 1 in 1 VIAL, PHARMACY BULK PACKAGE INJECTION, POWDER, FOR SOLUTION 1 19 0781-9409-95 Ampicillin 10 in 1 PACKAGE INJECTION, POWDER, FOR SOLUTION 10 19
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-9409 AMPICILLIN (AMPICILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [SANDOZ INC] 19 Current NDC, Legacy NDC, 2 package rows 20240518_5308ddfa-4a5b-4f7b-83ce-9d1b528e050d.zip
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0781-9409-46 00781940946 1 in 1 VIAL, PHARMACY BULK PACKAGE Historical 0781-9409-95 00781940995 10 VIAL, PHARMACY BULK PACKAGE in 1 PACKAGE (0781-9409-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE (0781-9409-46) 1971-03-03 0000-00-00 No No Current