Testopel
- Product NDC
- 43773-1001
- 11-digit product format
- 437731001
- Labeler code
- 43773
- Product ID
- 43773-1001_28c87785-4554-4172-9b11-f6a9d72923a8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TESTOSTERONE
- Dosage form
- PELLET
- Route
- SUBCUTANEOUS
- Labeler
- Slate Pharma
- Application
- ANDA080911
- Marketing category
- ANDA
- Marketing start
- 2009-07-21
- Marketing end
- 0000-00-00
- Substance
- TESTOSTERONE
- Active strength
- 75 mg/1
- Pharmacologic classes
- Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]
- DEA schedule
- CIII
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 2db4fc38-a116-b0ab-3dae-57df54e5f212 | Product name | 2 | 20250121 |
| 386d1b2a-e9b7-0c83-111f-2a77b92895b3 | Product name | 5 | 20240422 |
| 7d55b53c-798b-47ae-992b-3921493a8303 | Product name | 1 | 20230322 |
| 8d753fd6-75b2-4f12-bcbf-339392960afa | Product name | 1 | 20230303 |
| 4fbda828-a5be-46fe-83ec-a88da4359919 | Product name | 1 | 20230104 |
| 93cc9bee-8bdc-273d-ec7f-c2c52535317a | Product name | 7 | 20210902 |
| a6389cd1-36d1-4b5c-9934-1139bee93605 | Product name | 5 | 20210601 |
| f4f0889f-ee8b-471f-9a37-02a035280637 | Product name | 1 | 20200122 |
| 09e1afd3-f431-4380-82c5-438884c25615 | Product name | 1 | 20190111 |
| a6389cd1-36d1-4b5c-9934-1139bee93605 | Product name | 3 | 20171212 |
| 502efed8-01a5-ef6a-61c6-fe8302b6e26b | Product name | 2 | 20171113 |
| 8b700cfd-17dd-41a2-90f5-a80ae8a989a2 | Product name | 1 | 20171113 |
| 9ce0e503-4ae7-2c6a-39ae-85285c29db68 | Product name | 2 | 20171113 |
| 96bdf4b3-71cd-433d-9723-89e50f852992 | Product name | 1 | 20150810 |
| ed2e617f-f28a-1df1-f9fc-c79702f31271 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 43773-1001-2 | 2019-11-27 | C162847 | 48780-1 | 9855d018-e846-cd31-e053-dbdaa90ab51a | a1741a0b-3d4c-42dc-880d-a06e96cce9ef |
| 43773-1001-3 | 2019-11-27 | C162847 | 48780-1 | 9855d018-e846-cd31-e053-dbdaa90ab51a | a1741a0b-3d4c-42dc-880d-a06e96cce9ef |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43773-1001-2 | Testopel | 1 in 1 AMPULE | PELLET | 1 | 2 | |
| 43773-1001-2 | Testopel | 10 in 1 BOX | PELLET | 10 | 2 | |
| 43773-1001-3 | Testopel | 1 in 1 AMPULE | PELLET | 1 | 2 | |
| 43773-1001-3 | Testopel | 100 in 1 BOX | PELLET | 100 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43773-1001-2 | EA - Each | 43773-1001 | c1ea4802-1918-4e6b-8582-63726dad4763 | 1 | 2012-07-24 |
| 43773-1001-3 | EA - Each | 43773-1001 | 521a82dd-a1c9-45d5-86b4-3361fe2a33ba | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| TESTOSTERONE | ACTIVE INGREDIENT | 3XMK78S47O | TESTOPEL (TESTOSTERONE) PELLET [SLATE PHARMA] | 2 | |
| TESTOSTERONE | ACTIVE MOIETY | 3XMK78S47O | TESTOPEL (TESTOSTERONE) PELLET [SLATE PHARMA] | 2 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | TESTOPEL (TESTOSTERONE) PELLET [SLATE PHARMA] | 2 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | TESTOPEL (TESTOSTERONE) PELLET [SLATE PHARMA] | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 43773-1001 | TESTOPEL (TESTOSTERONE) PELLET [SLATE PHARMA] | 2 | Legacy NDC, 4 package rows | 20130704_a1741a0b-3d4c-42dc-880d-a06e96cce9ef.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 404405 | TESTOPEL 75 MG Subcutaneous Pellet Drug Implant | PSN | a1741a0b-3d4c-42dc-880d-a06e96cce9ef | 2 |
| 318240 | testosterone 75 MG Subcutaneous Pellet Drug Implant | PSN | a1741a0b-3d4c-42dc-880d-a06e96cce9ef | 2 |
| 404405 | testosterone 75 MG Drug Implant [Testopel] | SBD | a1741a0b-3d4c-42dc-880d-a06e96cce9ef | 2 |
| 318240 | testosterone 75 MG Drug Implant | SCD | a1741a0b-3d4c-42dc-880d-a06e96cce9ef | 2 |
| 404405 | Testopel 75 MG Drug Implant | SY | a1741a0b-3d4c-42dc-880d-a06e96cce9ef | 2 |
| 404405 | Testopel 75 MG Subcutaneous Pellet | SY | a1741a0b-3d4c-42dc-880d-a06e96cce9ef | 2 |
| 318240 | testosterone 75 MG Implant Pellet | SY | a1741a0b-3d4c-42dc-880d-a06e96cce9ef | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 43773-1001-2 | 43773100102 | 1 in 1 AMPULE | Historical |
| 43773-1001-3 | 43773100103 | 1 in 1 AMPULE | Historical |