FDA.reportPublic FDA data

SULFAMYLON

Product NDC
16571-723
11-digit product format
165710723
Labeler code
16571
Product ID
16571-723_58d3a059-d175-4740-bf57-f156588c99b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mafenide acetate
Dosage form
CREAM
Route
TOPICAL
Labeler
Rising Pharma Holdings, Inc.
Application
NDA016763
Marketing category
NDA
Marketing start
2020-05-18
Substance
MAFENIDE ACETATE
Active strength
85 mg/g
Pharmacologic classes
Methylated Sulfonamide Antibacterial [EPC], Methylated Sulfonamides [EXT]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SULFAMYLON
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MAFENIDE ACETATE85 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRQ6LP6Z0WY
Rxcui201185, 311406

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
a68e9f57-2575-4959-9f08-10a33b538785Product name120170828
85be6c97-d74a-e96c-07f8-9af4f297edabProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
16571-723-122023-07-31C16284748780-10191ceaa-68b4-198a-e063-dbdaa90aec3e008eaa23-8f19-4e39-85ff-540c1c834a9e
16571-723-482023-07-31C16284748780-10191ceaa-68b4-198a-e063-dbdaa90aec3e008eaa23-8f19-4e39-85ff-540c1c834a9e
16571-723-602023-07-31C16284748780-10191ceaa-68b4-198a-e063-dbdaa90aec3e008eaa23-8f19-4e39-85ff-540c1c834a9e
16571-723-122023-07-28C16284748780-10191ceaa-68b4-198a-e063-dbdaa90aec3e008eaa23-8f19-4e39-85ff-540c1c834a9e
16571-723-482023-07-28C16284748780-10191ceaa-68b4-198a-e063-dbdaa90aec3e008eaa23-8f19-4e39-85ff-540c1c834a9e
16571-723-602023-07-28C16284748780-10191ceaa-68b4-198a-e063-dbdaa90aec3e008eaa23-8f19-4e39-85ff-540c1c834a9e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16571-723-12SULFAMYLON113.4 g in 1 TUBECREAM113.42
16571-723-12SULFAMYLON1 in 1 CARTONCREAM12
16571-723-48SULFAMYLON453.6 g in 1 JARCREAM453.62
16571-723-60SULFAMYLON56.7 g in 1 TUBECREAM56.72
16571-723-60SULFAMYLON1 in 1 CARTONCREAM12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-723-48GM - Gram16571-723e386dedc-a477-4229-b104-c39cc92524d112021-06-02
16571-723-60GM - Gram16571-72357d7123b-a209-4df3-96c6-edb95146516e12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-723SULFAMYLON (MAFENIDE ACETATE) CREAM [RISING PHARMA HOLDINGS, INC.]2Current NDC, Legacy NDC, 5 package rows20230731_008eaa23-8f19-4e39-85ff-540c1c834a9e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311406mafenide acetate 8.5 % Topical CreamPSN008eaa23-8f19-4e39-85ff-540c1c834a9e2
201185Sulfamylon 8.5 % Topical CreamPSN008eaa23-8f19-4e39-85ff-540c1c834a9e2
201185mafenide 85 MG/ML Topical Cream [Sulfamylon]SBD008eaa23-8f19-4e39-85ff-540c1c834a9e2
311406mafenide 85 MG/ML Topical CreamSCD008eaa23-8f19-4e39-85ff-540c1c834a9e2
311406mafenide (as mafenide acetate) 8.5 % Topical CreamSY008eaa23-8f19-4e39-85ff-540c1c834a9e2
201185Sulfamylon 8.5 % Topical CreamSY008eaa23-8f19-4e39-85ff-540c1c834a9e2
201185Sulfamylon 85 MG/ML Topical CreamSY008eaa23-8f19-4e39-85ff-540c1c834a9e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16571-723-12165710723121 TUBE in 1 CARTON (16571-723-12) / 113.4 g in 1 TUBE1 tube2020-05-180000-00-00NoNoCurrent
16571-723-4816571072348453.6 g in 1 JAR (16571-723-48) 453.6 g2020-05-180000-00-00NoNoCurrent
16571-723-60165710723601 TUBE in 1 CARTON (16571-723-60) / 56.7 g in 1 TUBE1 tube2020-05-180000-00-00NoNoCurrent