Home NDC 17856-0684-2 Aripiprazole
Product NDC 17856-0684
Requested package NDC 17856-0684-2
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 2026-02-19 14:30 UTC 2026-02 A216150-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2023-11-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216150-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2023-11-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216150-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2023-11-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216150-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2023-11-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216150-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2023-11-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216150-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2023-11-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216150-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2023-11-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216150-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2023-11-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216150-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2023-11-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216150-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2023-11-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216150-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2023-11-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216150-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2023-11-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216150-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2023-11-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216150-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2023-11-01 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216150-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2023-11-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216150-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2023-11-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216150-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2023-11-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216150-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2023-11-01 a72a2bbeb626…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216150-001 ARIPIPRAZOLE 1MG/ML SOLUTION / ORAL AA 2023-11-01 a50c72e98297…
Observed Orange Book normalized TE history# 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 17856-0684-2 17856068402 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0684-2) / 10 mL in 1 CUP, UNIT-DOSE (17856-0684-4) 2025-01-29 No No Current