Childrens Ibuprofen

Product NDC: 0121-1836
11-digit product format: 001211836
Labeler code: 0121
Product ID: 0121-1836_648ca080-bdbd-7f71-e053-2991aa0acbe2
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: SUSPENSION
Route: ORAL
Labeler: Pharmaceutical Associates, Inc.
Application: ANDA074937
Marketing category: ANDA
Marketing start: 2014-12-01
Marketing end: 0000-00-00
Substance: IBUPROFEN
Active strength: 100 mg/5mL
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0121-1836-05	2023-10-13	C162847	48780-1	d6a99b39-d045-a426-e053-dadaa90af4c2	d7fc559e-8cd3-4f31-9a89-150ad97eb890
0121-1836-05	2022-01-28	C162847	48780-1	d6a99b39-d045-a426-e053-dadaa90af4c2	d7fc559e-8cd3-4f31-9a89-150ad97eb890

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0121-1836-05	ML - Milliliter	0121-1836	87fdadb7-1770-4abb-9e6c-b5f07b36b007	1	2015-04-03

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0121-1836-05	00121183605	10 TRAY in 1 CASE (0121-1836-05) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE	10 tray	2014-12-01	0000-00-00	No	No	Current