FDA.reportPublic FDA data

BETAMETHASONE DIPROPIONATE

Product NDC
45802-505
11-digit product format
458020505
Labeler code
45802
Product ID
45802-505_46112f27-facd-420e-9de1-289de334cbf9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
betamethasone dipropionate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA215847
Marketing category
ANDA
Marketing start
2022-05-20
Substance
BETAMETHASONE DIPROPIONATE
Active strength
.5 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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BETAMETHASONE DIPROPIONATE.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii826Y60901U
Rxcui197405

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dde7b902-54a1-627e-12f1-9e6d244ab88cProduct name420250317
69b49899-11cf-4f7e-bd0a-7dc93b27311bProduct name320250130
bbdc14c7-d940-43b5-a2f7-36c425991f3cProduct name120240320
0a2fcc35-464b-9ec2-a622-753662cdd48cProduct name320240216
6f762601-17ef-4321-8f47-77783d3c4d8bProduct name320231116
1dbefad7-ab34-69c3-e51a-e7148aa38f70Product name520220921
7fea2046-07a9-4bb6-9409-828ac6f1f6dfProduct name120210201
f059f1a2-0e64-4839-9a7f-42687c91a44bProduct name120201007
4ea9e4b5-b452-48ad-9b25-b9a4d403405dProduct name120160310
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
4f07db9b-3707-3e2c-05b5-d7852ba808c4Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-505-14BETAMETHASONE DIPROPIONATE15 g in 1 TUBEOINTMENT153
45802-505-14BETAMETHASONE DIPROPIONATE1 in 1 CARTONOINTMENT13
45802-505-84BETAMETHASONE DIPROPIONATE1 in 1 CARTONOINTMENT13
45802-505-84BETAMETHASONE DIPROPIONATE45 g in 1 TUBEOINTMENT453

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-505-14GM - Gram45802-5058b94c0b4-07d1-4d2d-b569-fefbd7854b0f12022-05-04
45802-505-84GM - Gram45802-505a17be69c-d713-4fae-b814-6d23301eabb212022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-505BETAMETHASONE DIPROPIONATE OINTMENT [PADAGIS ISRAEL PHARMACEUTICALS LTD]3Current NDC, Legacy NDC, 4 package rows20250429_0e56e8bc-b79e-43c6-945e-c333a599bfc8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197405betamethasone dipropionate 0.05 % Topical OintmentPSNd6702ddc-4a1d-4d0d-bebd-bc615ed0bc35104
197405betamethasone dipropionate 0.05 % Topical OintmentPSN1d40b962-5d97-4416-b46d-b0785acd261d104
197405betamethasone 0.0005 MG/MG Topical OintmentSCDd6702ddc-4a1d-4d0d-bebd-bc615ed0bc35104
197405betamethasone 0.0005 MG/MG Topical OintmentSCD1d40b962-5d97-4416-b46d-b0785acd261d104
197405betamethasone 0.05 % Topical OintmentSYd6702ddc-4a1d-4d0d-bebd-bc615ed0bc35104
197405betamethasone 0.05 % Topical OintmentSY1d40b962-5d97-4416-b46d-b0785acd261d104
197405betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Topical OintmentSY1d40b962-5d97-4416-b46d-b0785acd261d104
197405betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Topical OintmentSYd6702ddc-4a1d-4d0d-bebd-bc615ed0bc35104
197405betamethasone dipropionate 0.05 % Topical OintmentPSN13196f0a-6daf-4f62-853c-ac2ac261ce43101
197405betamethasone 0.0005 MG/MG Topical OintmentSCD13196f0a-6daf-4f62-853c-ac2ac261ce43101
197405betamethasone 0.05 % Topical OintmentSY13196f0a-6daf-4f62-853c-ac2ac261ce43101
197405betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Topical OintmentSY13196f0a-6daf-4f62-853c-ac2ac261ce43101
197405betamethasone dipropionate 0.05 % Topical OintmentPSN52c0e92f-986e-45e7-99cf-9a13ac386b1d100
197405betamethasone 0.0005 MG/MG Topical OintmentSCD52c0e92f-986e-45e7-99cf-9a13ac386b1d100
197405betamethasone 0.05 % Topical OintmentSY52c0e92f-986e-45e7-99cf-9a13ac386b1d100
197405betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Topical OintmentSY52c0e92f-986e-45e7-99cf-9a13ac386b1d100
197405betamethasone dipropionate 0.05 % Topical OintmentPSN0e56e8bc-b79e-43c6-945e-c333a599bfc83
197405betamethasone 0.0005 MG/MG Topical OintmentSCD0e56e8bc-b79e-43c6-945e-c333a599bfc83
197405betamethasone 0.05 % Topical OintmentSY0e56e8bc-b79e-43c6-945e-c333a599bfc83
197405betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Topical OintmentSY0e56e8bc-b79e-43c6-945e-c333a599bfc83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-505-14458020505141 TUBE in 1 CARTON (45802-505-14) / 15 g in 1 TUBE1 tube2022-05-200000-00-00NoNoCurrent
45802-505-84458020505841 TUBE in 1 CARTON (45802-505-84) / 45 g in 1 TUBE1 tube2022-05-200000-00-00NoNoCurrent