Home NDC 67850-130 AMPICILLIN and SULBACTAM
Product NDC 67850-130
11-digit product format 678500130
Labeler code 67850
Product ID 67850-130_ac720207-d1c2-4aa3-b45e-f314e62dccb0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ampicillin and Sulbactam for injection
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Methapharm, Inc.
Application ANDA201406
Marketing category ANDA
Marketing start 2022-01-01
Marketing end 0000-00-00
Substance AMPICILLIN SODIUM; SULBACTAM SODIUM
Active strength 1 g/1; g/1
Pharmacologic classes Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 18 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 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 67850-130-10 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 67850-130-10 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 67850-130-10 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 67850-130-10 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 67850-130-10 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 67850-130-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 67850-130-10 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 67850-130-10 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 67850-130-10 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A201406-001 AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07 A201406-002 AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 84 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 A201406-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201406-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201406-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201406-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201406-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201406-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201406-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201406-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201406-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201406-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201406-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201406-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201406-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201406-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201406-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201406-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201406-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201406-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201406-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201406-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201406-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201406-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201406-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201406-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201406-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201406-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201406-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201406-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201406-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A201406-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201406-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201406-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201406-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A201406-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201406-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A201406-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201406-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A201406-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201406-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A201406-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2015-12-07 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
FDA-Initiated Inactive NDC Indexing# 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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 67850-130-10 67850013010 10 VIAL, GLASS in 1 CARTON (67850-130-10) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (67850-130-00) 2022-01-01 0000-00-00 No No Current