Home NDC 17856-0684 Aripiprazole
Product NDC 17856-0684
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# 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
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 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 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 17856-0684-3 17856068403 5 mL in 1 CUP, UNIT-DOSE 5 ml Historical 17856-0684-4 17856068404 10 mL in 1 CUP, UNIT-DOSE 10 ml Historical