Prostazen

Product NDC
80353-702
Requested package NDC
80353-702-01
11-digit product format
803530702
Labeler code
80353
Product ID
80353-702_4e38e5b2-1fc2-dfcb-e063-6294a90a3dc8
Type
HUMAN OTC DRUG
Nonproprietary name
Enlarged Prostate, Prostatic Utricle Function, and Prostatitis Recovery
Dosage form
CAPSULE
Route
ORAL
Labeler
HCBIOPHARM LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2022-01-12
Substance
REYNOUTRIA JAPONICA ROOT; RUBIA CORDIFOLIA ROOT; SAW PALMETTO
Active strength
1; 1; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Prostazen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SAW PALMETTO1 [hp_X]/1
RUBIA CORDIFOLIA ROOT1 [hp_X]/1
REYNOUTRIA JAPONICA ROOT1 [hp_X]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
J7WWH9M8QSInternal UNII lookup
4V873H15CGInternal UNII lookup
7TRV45YZF7Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d16bc0cb-b9a6-9a24-e053-2995a90a7cd4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80353-702-01Prostazen1 in 1 BOXCAPSULE16
80353-702-02Prostazen1 in 1 BOTTLECAPSULE16
80353-702-03Prostazen60 in 1 CAPSULECAPSULE606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80353-702PROSTAZEN (ENLARGED PROSTATE, PROSTATIC UTRICLE FUNCTION, AND PROSTATITIS RECOVERY) CAPSULE [HCBIOPHARM LLC]5Current NDC, Legacy NDC, 3 package rows20250104_d16bc0cb-b9a6-9a24-e053-2995a90a7cd4.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ProstazenENLARGED PROSTATE, PROSTATIC UTRICLE FUNCTION, AND PROSTATITIS RECOVERYHCBIOPHARM LLCd16bc0cb-b9a6-9a24-e053-2995a90a7cd42026-03-30WarningsExact identifier
ndc (package): 80353-702-01
ndc (product): 80353-702
ndc11 (package): 80353070201

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80353-702-01803530702011 BOTTLE in 1 BOX (80353-702-01) / 1 CAPSULE in 1 BOTTLE (80353-702-02) / 60 CAPSULE in 1 CAPSULE (80353-702-03) 1 bottle2022-01-120000-00-00NoNoCurrent