Hydroxyzine Pamoate

Product NDC
68788-7280
11-digit product format
687887280
Labeler code
68788
Product ID
68788-7280_60edd334-ed91-48d1-b9bb-07cd312118a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA040156
Marketing category
ANDA
Marketing start
2019-01-16
Marketing end
0000-00-00
Substance
HYDROXYZINE PAMOATE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7280-1EA - Each68788-72802e6c0821-398e-4918-a7cd-98a50bc60c5212019-04-11
68788-7280-2EA - Each68788-72805d444f63-b3aa-42e2-983f-5cccdb1e491712019-04-11
68788-7280-3EA - Each68788-7280fd838f5c-b41a-4ef9-92ba-8ec542252f0e12019-04-11
68788-7280-5EA - Each68788-7280b45ed499-05d5-4c7d-869f-290ec3c02c5612019-04-11
68788-7280-6EA - Each68788-72801ea73adf-175a-47a3-8bbb-ce6c7332a03c12019-04-11
68788-7280-9EA - Each68788-7280b369b533-f8d4-47a0-a967-93dcd6df3b1012019-04-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7280-168788728001100 CAPSULE in 1 BOTTLE, PLASTIC (68788-7280-1) 100 capsule2019-01-160000-00-00NoNoCurrent
68788-7280-26878872800220 CAPSULE in 1 BOTTLE, PLASTIC (68788-7280-2) 20 capsule2019-01-160000-00-00NoNoCurrent
68788-7280-36878872800330 CAPSULE in 1 BOTTLE, PLASTIC (68788-7280-3) 30 capsule2019-01-160000-00-00NoNoCurrent
68788-7280-56878872800515 CAPSULE in 1 BOTTLE, PLASTIC (68788-7280-5) 15 capsule2019-01-160000-00-00NoNoCurrent
68788-7280-66878872800660 CAPSULE in 1 BOTTLE, PLASTIC (68788-7280-6) 60 capsule2019-01-160000-00-00NoNoCurrent
68788-7280-96878872800990 CAPSULE in 1 BOTTLE, PLASTIC (68788-7280-9) 90 capsule2019-01-160000-00-00NoNoCurrent