Refissa Tretinoin (Emollient)

Product NDC
42851-012
11-digit product format
428510012
Labeler code
42851
Product ID
42851-012_a3c1c3b4-13ef-a625-e053-2995a90af78f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tretinoin
Dosage form
CREAM
Route
TOPICAL
Labeler
ZO Skin Health, Inc.
Application
ANDA076498
Marketing category
ANDA
Marketing start
2017-04-03
Marketing end
0000-00-00
Substance
TRETINOIN
Active strength
1 mg/g
Pharmacologic classes
Retinoid [EPC],Retinoids [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42851-012-20GM - Gram42851-012e1e07bfe-f0f5-4fa8-9a66-50b9fa158a6912018-08-13
42851-012-40GM - Gram42851-0128a5fd952-8538-45eb-9ee7-bbdca3b4662012018-08-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42851-012-20428510012201 TUBE in 1 CARTON (42851-012-20) > 20 g in 1 TUBE1 tube2017-04-030000-00-00NoNoCurrent
42851-012-40428510012401 TUBE in 1 CARTON (42851-012-40) > 40 g in 1 TUBE1 tube2017-04-030000-00-00NoNoCurrent