UREA

Product NDC
42291-849
Requested package NDC
42291-849-19
11-digit product format
422910849
Labeler code
42291
Product ID
42291-849_e155ad25-1bcd-82f4-e053-2a95a90a5158
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
UREA
Dosage form
CREAM
Route
TOPICAL
Labeler
AvKARE
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2017-11-06
Marketing end
0000-00-00
Substance
UREA
Active strength
40 g/100g
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage42291-84942291-849-19DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-849-19GM - Gram42291-8496c492a19-4d37-4013-b60b-66dd8634263712018-02-20
42291-849-28GM - Gram42291-84966e1753a-506a-4941-b522-71a8290d50b512018-02-20
42291-849-85GM - Gram42291-8491215c538-a12a-4b82-b5ea-3a64660d3c0912018-02-20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-849-19422910849191 BOTTLE, PLASTIC in 1 CARTON (42291-849-19) > 198 g in 1 BOTTLE, PLASTIC2017-11-060000-00-00NoNoCurrent