FDA.reportPublic FDA data

Testim

Product NDC
66887-001
11-digit product format
668870001
Labeler code
66887
Product ID
66887-001_366a5e88-4a23-46b0-94e5-e7f7deb7acbe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
testosterone
Dosage form
GEL
Route
TRANSDERMAL
Labeler
Endo USA, Inc.
Application
NDA021454
Marketing category
NDA
Marketing start
2002-10-31
Substance
TESTOSTERONE
Active strength
50 mg/5g
Pharmacologic classes
Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2027-12-31
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
N021454-001TESTIMTESTOSTERONE50MG/5GM PACKETGEL / TRANSDERMALAB2RLD, RS2002-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N021454-001AB2

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 22:54:322026-06N021454-001TESTIM50MG/5GM PACKETGEL / TRANSDERMALAB2RLD, RS2002-10-31a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N021454-001AB21a50c72e98297…

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
TestimTESTOSTERONEEndo USA, Inc.9f2aae1f-898d-4955-be31-678e0cf853952025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021454
application number: NDA021454
ndc (product): 66887-001

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TESTOSTERONE50 mg/5g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3XMK78S47OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1597129Internal RxNorm lookup
1597132Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9f2aae1f-898d-4955-be31-678e0cf85395Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2db4fc38-a116-b0ab-3dae-57df54e5f212Product name220250121
386d1b2a-e9b7-0c83-111f-2a77b92895b3Product name520240422
7d55b53c-798b-47ae-992b-3921493a8303Product name120230322
8d753fd6-75b2-4f12-bcbf-339392960afaProduct name120230303
4fbda828-a5be-46fe-83ec-a88da4359919Product name120230104
93cc9bee-8bdc-273d-ec7f-c2c52535317aProduct name720210902
a6389cd1-36d1-4b5c-9934-1139bee93605Product name520210601
f4f0889f-ee8b-471f-9a37-02a035280637Product name120200122
09e1afd3-f431-4380-82c5-438884c25615Product name120190111
a6389cd1-36d1-4b5c-9934-1139bee93605Product name320171212
502efed8-01a5-ef6a-61c6-fe8302b6e26bProduct name220171113
8b700cfd-17dd-41a2-90f5-a80ae8a989a2Product name120171113
9ce0e503-4ae7-2c6a-39ae-85285c29db68Product name220171113
96bdf4b3-71cd-433d-9723-89e50f852992Product name120150810
ed2e617f-f28a-1df1-f9fc-c79702f31271Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66887-001-05Testim5 g in 1 TUBEGEL529
66887-001-05Testim30 in 1 CARTONGEL3029

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66887-001-05GM - Gram66887-001be3f05b3-5ebe-4511-8a86-de5d8b68b6ce12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TESTOSTERONEACTIVE INGREDIENT3XMK78S47OTESTIM (TESTOSTERONE) GEL [AUXILIUM PHARMACEUTICALS, INC.]14
TESTOSTERONEACTIVE MOIETY3XMK78S47OTESTIM (TESTOSTERONE) GEL [AUXILIUM PHARMACEUTICALS, INC.]14
TESTOSTERONEACTIVE INGREDIENT3XMK78S47OTESTIM (TESTOSTERONE) GEL [STAT RX USA]1
TESTOSTERONEACTIVE INGREDIENT3XMK78S47OTESTIM (TESTOSTERONE) GEL [PHYSICIANS TOTAL CARE, INC.]1
TESTOSTERONEACTIVE MOIETY3XMK78S47OTESTIM (TESTOSTERONE) GEL [STAT RX USA]1
TESTOSTERONEACTIVE MOIETY3XMK78S47OTESTIM (TESTOSTERONE) GEL [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66887-001TESTIM (TESTOSTERONE) GEL [ENDO USA, INC.]26Current NDC, Legacy NDC, 2 package rows20240913_9f2aae1f-898d-4955-be31-678e0cf85395.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1597132Testim 1 % (50 MG / 5GM) Transdermal GelPSN9f2aae1f-898d-4955-be31-678e0cf8539529
1597129testosterone 1 % (50 MG / 5 GM) Transdermal GelPSN9f2aae1f-898d-4955-be31-678e0cf8539529
15971325000 MG testosterone 0.01 MG/MG Topical Gel [Testim]SBD9f2aae1f-898d-4955-be31-678e0cf8539529
15971295000 MG testosterone 0.01 MG/MG Topical GelSCD9f2aae1f-898d-4955-be31-678e0cf8539529
15971325000 MG Testim 0.01 MG/MG Topical GelSY9f2aae1f-898d-4955-be31-678e0cf8539529
1597132Testim 1 % (50 MG) Transdermal Gel, 5 GMSY9f2aae1f-898d-4955-be31-678e0cf8539529
1597129testosterone 50 MG Transdermal Gel, 5 GMSY9f2aae1f-898d-4955-be31-678e0cf8539529
1597132Testim 1 % (50 MG / 5GM) Transdermal GelPSN0d90cadf-d579-47bf-b655-7e9d3bd1cabe1
1597132Testim 1 % (50 MG / 5GM) Transdermal GelPSN48f8aa83-e043-41b8-9a20-dbb0980458951
1597129testosterone 1 % (50 MG / 5 GM) Transdermal GelPSN48f8aa83-e043-41b8-9a20-dbb0980458951
1597129testosterone 1 % (50 MG / 5 GM) Transdermal GelPSN0d90cadf-d579-47bf-b655-7e9d3bd1cabe1
15971325000 MG testosterone 0.01 MG/MG Topical Gel [Testim]SBD48f8aa83-e043-41b8-9a20-dbb0980458951
15971325000 MG testosterone 0.01 MG/MG Topical Gel [Testim]SBD0d90cadf-d579-47bf-b655-7e9d3bd1cabe1
15971295000 MG testosterone 0.01 MG/MG Topical GelSCD48f8aa83-e043-41b8-9a20-dbb0980458951
15971295000 MG testosterone 0.01 MG/MG Topical GelSCD0d90cadf-d579-47bf-b655-7e9d3bd1cabe1
15971325000 MG Testim 0.01 MG/MG Topical GelSY48f8aa83-e043-41b8-9a20-dbb0980458951
15971325000 MG Testim 0.01 MG/MG Topical GelSY0d90cadf-d579-47bf-b655-7e9d3bd1cabe1
1597132Testim 1 % (50 MG) Transdermal Gel, 5 GMSY48f8aa83-e043-41b8-9a20-dbb0980458951
1597132Testim 1 % (50 MG) Transdermal Gel, 5 GMSY0d90cadf-d579-47bf-b655-7e9d3bd1cabe1
1597129testosterone 50 MG Transdermal Gel, 5 GMSY48f8aa83-e043-41b8-9a20-dbb0980458951
1597129testosterone 50 MG Transdermal Gel, 5 GMSY0d90cadf-d579-47bf-b655-7e9d3bd1cabe1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66887-001-056688700010530 TUBE in 1 CARTON (66887-001-05) / 5 g in 1 TUBE30 tube2002-10-310000-00-00NoNoCurrent