StrataGraft

Product NDC: 73612-201
Requested package NDC: 73612-201-01
11-digit product format: 736120201
Labeler code: 73612
Product ID: 73612-201_c09db658-6b7c-40f8-b4f2-8662e75d2b1e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat
Dosage form: CELLULAR SHEET
Route: TOPICAL
Labeler: Stratatech Corporation
Application: BLA125730
Marketing category: BLA
Marketing start: 2021-06-15
Marketing end: 0000-00-00
Substance: VIABLE AND METABOLICALLY ACTIVE ALLOGENEIC HUMAN NIKS KERATINOCYTES AND HUMAN DERMAL FIBROBLASTS CELLULARIZED LAYERED SCAFFOLD
Active strength: 1 cm2/cm2
NDC exclude flag: No
Listing certified through: 2022-12-31
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	73612-201	73612-201-01	D	Discontinued by firm		2026-10-05

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 · 9 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125730	StrataGraft	Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat	351(a)	Disc	2026-09-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
73612-201-01	73612020101	1 POUCH in 1 CARTON (73612-201-01) > 100 cm2 in 1 POUCH	1 pouch	2021-10-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
StrataGraft - Stratatech Corporation	Stratatech Corporation	2024-01-31	HUMAN PRESCRIPTION DRUG LABEL	4