Caverject Impulse
- Product NDC
- 63539-121
- 11-digit product format
- 635390121
- Labeler code
- 63539
- Product ID
- 63539-121_0dcd3231-552e-4243-bbc9-b8ed733d3ff4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Alprostadil
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRACAVERNOUS
- Labeler
- U.S. Pharmaceuticals
- Application
- NDA021212
- Marketing category
- NDA
- Marketing start
- 2014-05-04
- Marketing end
- 0000-00-00
- Substance
- ALPROSTADIL
- Active strength
- 10 ug/.5mL
- Pharmacologic classes
- Genitourinary Arterial Vasodilation [PE],Prostaglandin Analog [EPC],Prostaglandin E1 Agonist [EPC],Prostaglandin Receptor Agonists [MoA],Prostaglandins [CS],Venous Vasodilation [PE]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ALPROSTADIL | ACTIVE INGREDIENT | F5TD010360 | CAVERJECT IMPULSE (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [U.S. PHARMACEUTICALS] | 1 | |
| ALPROSTADIL | ACTIVE MOIETY | F5TD010360 | CAVERJECT IMPULSE (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [U.S. PHARMACEUTICALS] | 1 | |
| ALFADEX | INACTIVE INGREDIENT | Z1LH97KTRM | CAVERJECT IMPULSE (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [U.S. PHARMACEUTICALS] | 1 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | CAVERJECT IMPULSE (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [U.S. PHARMACEUTICALS] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | CAVERJECT IMPULSE (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [U.S. PHARMACEUTICALS] | 1 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | CAVERJECT IMPULSE (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [U.S. PHARMACEUTICALS] | 1 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | CAVERJECT IMPULSE (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [U.S. PHARMACEUTICALS] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | CAVERJECT IMPULSE (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [U.S. PHARMACEUTICALS] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | CAVERJECT IMPULSE (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [U.S. PHARMACEUTICALS] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63539-121 | CAVERJECT IMPULSE (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [U.S. PHARMACEUTICALS] | 3 | Legacy NDC | 20240903_d8f85a7e-becb-4e15-9829-40e8f359140a.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63539-121-11 | 63539012111 | 2 SYRINGE in 1 CARTON (63539-121-11) > .5 mL in 1 SYRINGE (63539-121-10) | 2 syringe | 2014-05-04 | 0000-00-00 | No | No | Current |