Hydroxyzine Pamoate

Product NDC
51079-077
11-digit product format
510790077
Labeler code
51079
Product ID
51079-077_9aee1f84-b4b5-09a6-e053-2a95a90ae4d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA088496
Marketing category
ANDA
Marketing start
2007-11-26
Marketing end
2021-04-30
Substance
HYDROXYZINE PAMOATE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-077-01EA - Each51079-07790b11822-c91f-4206-b05e-20dd06d2639212013-02-13
51079-077-20EA - Each51079-07708dff23c-02f8-4a98-a963-93bc98bebed712012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-077-2051079007720100 BLISTER PACK in 1 CARTON (51079-077-20) > 1 CAPSULE in 1 BLISTER PACK (51079-077-01) 100 blister pack2007-11-262021-04-30NoNoCurrent