FDA.reportPublic FDA data

Fluticasone Propionate

Product NDC
0713-0632
11-digit product format
007130632
Labeler code
0713
Product ID
0713-0632_0abc4bef-4b22-8a3f-e063-6394a90ae599
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluticasone Propionate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
ANDA077168
Marketing category
ANDA
Marketing start
2006-05-31
Substance
FLUTICASONE PROPIONATE
Active strength
.05 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077168-001FLUTICASONE PROPIONATEFLUTICASONE PROPIONATE0.005%OINTMENT / TOPICALAB2006-03-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A077168-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A077168-001FLUTICASONE PROPIONATE0.005%OINTMENT / TOPICALAB2006-03-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A077168-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluticasone PropionateFLUTICASONE PROPIONATECosette Pharmaceuticals, Inc.e7ef2aaf-749c-66c9-2bdf-7214ab00060e2023-11-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077168
application number: ANDA077168
ndc (product): 0713-0632

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUTICASONE PROPIONATE.05 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O2GMZ0LF5WInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
895487Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e7ef2aaf-749c-66c9-2bdf-7214ab00060eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f4fb2f5a-dadb-40e3-a4b1-a2a58f5d9a33Product name320260126
343e8617-eb68-1e10-cfa9-8c30af285764Product name320240513
a31ad3df-8021-2ea1-94eb-0fe2f49b7729Product name420220719
813fe018-3e3c-40e4-8f71-7ab50f3dfe81Product name220180723
3bcd721e-0555-4bc3-96c6-690471ff9d94Product name120171113
9f9452df-fa34-43d4-97fe-c6605344c5a8Product name120171113
0e5a25a6-9f05-44b5-8449-aa63e59f7202Product name120170426
f3c5232f-03de-44f5-996a-90cd9c08bc60Product name120170426
1cb17fbb-0da4-2841-37bc-e7079783e1a2Product name120140508
667f427a-8698-a508-767a-53ed61b4c2e9Product name120140508
6a97ffc8-1d4d-a971-4978-85ba3a22eac9Product name120140508
6df84e13-2223-fa46-1e26-17e2f58a1e1cProduct name120140508
90fec588-984c-4375-cfd4-7e40114bdf80Product name120140508
9c1d3c48-b162-204b-f55b-e0f25c31c52eProduct name120140508
9fdb6139-394b-1510-4baf-bde68c419789Product name120140508
aef26912-037b-9a4e-db49-225ef6dfd8f1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0713-0632-15Fluticasone Propionate1 in 1 CARTONOINTMENT19
0713-0632-15Fluticasone Propionate15 g in 1 TUBEOINTMENT159
0713-0632-31Fluticasone Propionate1 in 1 CARTONOINTMENT19
0713-0632-31Fluticasone Propionate30 g in 1 TUBEOINTMENT309
0713-0632-60Fluticasone Propionate1 in 1 CARTONOINTMENT19
0713-0632-60Fluticasone Propionate60 g in 1 TUBEOINTMENT609

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0632-15GM - Gram0713-06327a9d5d7b-df2b-4dfe-8a2c-079b31a04f3012012-07-24
0713-0632-31GM - Gram0713-06329ab83485-25cc-4bbc-ba0d-c2e03c84a5a112012-07-24
0713-0632-60GM - Gram0713-0632440f872f-f5be-471f-b048-af52235042c712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Fluticasone PropionateACTIVE INGREDIENTO2GMZ0LF5WFLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) OINTMENT [GW LABORATORIES, INC]1
FluticasoneACTIVE MOIETYCUT2W21N7UFLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) OINTMENT [GW LABORATORIES, INC]1
Mineral OilINACTIVE INGREDIENTT5L8T28FGPFLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) OINTMENT [GW LABORATORIES, INC]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) OINTMENT [GW LABORATORIES, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0632FLUTICASONE PROPIONATE OINTMENT [COSETTE PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 6 package rows20231123_e7ef2aaf-749c-66c9-2bdf-7214ab00060e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895487fluticasone propionate 0.005 % Topical OintmentPSNe7ef2aaf-749c-66c9-2bdf-7214ab00060e9
895487fluticasone propionate 0.00005 MG/MG Topical OintmentSCDe7ef2aaf-749c-66c9-2bdf-7214ab00060e9
895487fluticasone propionate 0.005 % Topical OintmentSYe7ef2aaf-749c-66c9-2bdf-7214ab00060e9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0713-0632-15007130632151 TUBE in 1 CARTON (0713-0632-15) / 15 g in 1 TUBE1 tube2006-05-310000-00-00NoNoCurrent
0713-0632-31007130632311 TUBE in 1 CARTON (0713-0632-31) / 30 g in 1 TUBE1 tube2006-05-310000-00-00NoNoCurrent
0713-0632-60007130632601 TUBE in 1 CARTON (0713-0632-60) / 60 g in 1 TUBE1 tube2006-05-310000-00-00NoNoCurrent