Home NDC 83270-315-01 Ampicillin
Product NDC 83270-315
Requested package NDC 83270-315-01
11-digit product format 832700315
Labeler code 83270
Product ID 83270-315_519f2785-e1bf-14fb-e063-6294a90ad704
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ampicillin
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler ONESOURCE SPECIALTY PHARMA LIMITED
Application ANDA202198
Marketing category ANDA
Marketing start 2026-02-27
Substance AMPICILLIN SODIUM
Active strength 10 g/1
Pharmacologic classes Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202198-001 AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202198-001 AP
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.
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 2026-08-01 22:54:32 2026-06 A202198-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A202198-001 AP 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Ampicillin
Listing expiration 2027-12-31 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 83270-315-01 Ampicillin 1 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 1 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 83270-315-01 83270031501 1 INJECTION, POWDER, FOR SOLUTION in 1 CARTON (83270-315-01) 2026-02-27 No No Current