Home NDC 70594-087 Ampicillin
Product NDC 70594-087
11-digit product format 705940087
Labeler code 70594
Product ID 70594-087_2c29bd08-f467-4028-aac6-0a5b3007a5d3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name AMPICILLIN SODIUM
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Xellia Pharmaceuticals USA LLC
Application ANDA090583
Marketing category ANDA
Marketing start 2021-01-10
Marketing end 0000-00-00
Substance AMPICILLIN SODIUM
Active strength 2 g/1
Pharmacologic classes Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 70594-087-02 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 70594-087-02 367a005e9d99…383a685ebd0f…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090583-001 AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 A090583-002 AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 A090583-003 AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 A090583-004 AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 A090583-005 AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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 6 · 205 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 2026-02-19 14:30 UTC 2026-02 A090583-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090583-002 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090583-003 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090583-004 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090583-005 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090583-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090583-002 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090583-003 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090583-004 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090583-005 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090583-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090583-002 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090583-003 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090583-004 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090583-005 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090583-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090583-002 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090583-003 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090583-004 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090583-005 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090583-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090583-002 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090583-003 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090583-004 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090583-005 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090583-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090583-002 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090583-003 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090583-004 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090583-005 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090583-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090583-002 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090583-003 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090583-004 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090583-005 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090583-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090583-002 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090583-003 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090583-004 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090583-005 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2015-11-27 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 205 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70594-087 AMPICILLIN (AMPICILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [XELLIA PHARMACEUTICALS USA LLC] 2 Legacy NDC 20241212_94421dac-7865-49f8-ae52-871eee6465ac.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70594-087-02 70594008702 10 VIAL in 1 CARTON (70594-087-02) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70594-087-01) 10 vial 2021-01-10 0000-00-00 No No Current