ARIPIPRAZOLE

Product NDC: 70518-2508
11-digit product format: 705182508
Labeler code: 70518
Product ID: 70518-2508_d6a76b06-4eaf-56bf-e053-2995a90a0bbf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: aripiprazole
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA205363
Marketing category: ANDA
Marketing start: 2019-12-26
Marketing end: 0000-00-00
Substance: ARIPIPRAZOLE
Active strength: 15 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-2508-0	2022-01-30	C162847	48780-1	d6a99b39-cbd1-a426-e053-dadaa90af4c2	09f2593b-22e4-4507-9a68-649253548bd7
70518-2508-0	2022-01-28	C162847	48780-1	d6a99b39-cbd1-a426-e053-dadaa90af4c2	09f2593b-22e4-4507-9a68-649253548bd7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70518-2508-0	EA - Each	70518-2508	d2a7497a-8ce2-4ff8-b37c-feef82698474	1	2023-01-09
70518-2508-1	EA - Each	70518-2508	488df244-5376-4117-95f9-eef8a182cb62	1	2023-01-09

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2508-0	70518250800	30 POUCH in 1 BOX (70518-2508-0) > 1 TABLET in 1 POUCH (70518-2508-1)	30 pouch	2019-12-26	0000-00-00	No	No	Current