Home NDC 67850-022 AMPICILLIN
Product NDC 67850-022
11-digit product format 678500022
Labeler code 67850
Product ID 67850-022_8d1c1c38-c673-4a99-9a6b-f546c0379c5c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ampicillin Injection
Dosage form POWDER, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Methapharm Inc.
Application ANDA090354
Marketing category ANDA
Marketing start 2019-03-06
Marketing end 0000-00-00
Substance AMPICILLIN SODIUM
Active strength 2 g/2g
Pharmacologic classes Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090354-001 AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 A090354-002 AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 A090354-003 AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 A090354-004 AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 5 · 164 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 A090354-001 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090354-002 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090354-003 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090354-004 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090354-001 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090354-002 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090354-003 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090354-004 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090354-001 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090354-002 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090354-003 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090354-004 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090354-001 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090354-002 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090354-003 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090354-004 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090354-001 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090354-002 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090354-003 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090354-004 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090354-001 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090354-002 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090354-003 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090354-004 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090354-001 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090354-002 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090354-003 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090354-004 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090354-001 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090354-002 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090354-003 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090354-004 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090354-001 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090354-002 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090354-003 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090354-004 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090354-001 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090354-002 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090354-003 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090354-004 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67850-022 AMPICILLIN (AMPICILLIN INJECTION) POWDER, FOR SOLUTION [METHAPHARM INC.] 9 Legacy NDC 20241207_3f6275f9-ee6f-4087-b672-5611d6870558.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 · 3 matching rows.
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 67850-022-10 67850002210 10 VIAL in 1 PACKAGE (67850-022-10) > 2 g in 1 VIAL (67850-022-00) 10 vial 2019-03-06 0000-00-00 No No Current