Home NDC 17856-0684-1 Aripiprazole
Product NDC 17856-0684
Requested package NDC 17856-0684-1
11-digit product format 178560684
Labeler code 17856
Product ID 17856-0684_6f744c80-5232-41f6-abad-a81976e0b1f9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Aripiprazole oral
Dosage form SOLUTION
Route ORAL
Labeler ATLANTIC BIOLOGICALS CORP.
Application ANDA216150
Marketing category ANDA
Marketing start 2023-11-01
Substance ARIPIPRAZOLE
Active strength 1 mg/mL
Pharmacologic classes Atypical Antipsychotic [EPC]
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 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 A216150-001 ARIPIPRAZOLE ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2023-11-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216150-001 AA
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 A216150-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2023-11-01 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 A216150-001 AA 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 · 3 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Aripiprazole
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ARIPIPRAZOLE 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 82VFR53I78 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 485496 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 17856-0684-1 Aripiprazole 72 in 1 BOX, UNIT-DOSE SOLUTION 72 1 17856-0684-2 Aripiprazole 72 in 1 BOX, UNIT-DOSE SOLUTION 72 1 17856-0684-3 Aripiprazole 5 mL in 1 CUP, UNIT-DOSE SOLUTION 5 1 17856-0684-4 Aripiprazole 10 mL in 1 CUP, UNIT-DOSE SOLUTION 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17856-0684 ARIPIPRAZOLE (ARIPIPRAZOLE ORAL) SOLUTION [ATLANTIC BIOLOGICALS CORP.] 1 Current NDC, 4 package rows 20250130_042b725c-1c17-4cfb-80b2-c841226d795e.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 17856-0684-1 17856068401 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0684-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-0684-3) 2025-01-29 No No Current