olopatadine hydrochloride

Product NDC: 51293-838
11-digit product format: 512930838
Labeler code: 51293
Product ID: 51293-838_637fe31a-c464-47b1-b4ed-a2fa833ebd80
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: olopatadine hydrochloride
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: ECI Pharmaceuticals, LLC
Application: ANDA203152
Marketing category: ANDA
Marketing start: 2015-12-07
Marketing end: 0000-00-00
Substance: OLOPATADINE HYDROCHLORIDE
Active strength: 1 mg/mL
Pharmacologic classes: Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51293-838-85	2021-02-22	C162847	48780-1	ba0f9c33-1f1f-a910-e053-dadaa90a0b85	7e6b32d6-bd9c-40d5-97b7-fe62117ee049
51293-838-85	2021-01-29	C162847	48780-1	ba0f9c33-1f1f-a910-e053-dadaa90a0b85	7e6b32d6-bd9c-40d5-97b7-fe62117ee049

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51293-838-85	ML - Milliliter	51293-838	fa83a99d-f5c6-449e-bf86-42ed412857d7	1	2020-02-13

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2XG66W44KF	OLOPATADINE HYDROCHLORIDE	140462-76-6	OLOPATADINE HYDROCHLORIDE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51293-838-85	51293083885	5 mL in 1 BOTTLE, PLASTIC (51293-838-85)	5 ml	2019-10-01	0000-00-00	No	No	Current