Vardenafil Hydrochloride
- Product NDC
- 33342-152
- 11-digit product format
- 333420152
- Labeler code
- 33342
- Product ID
- 33342-152_b02d220c-5dd4-4557-880a-7d4c0d8927b9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Vardenafil Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA204632
- Marketing category
- ANDA
- Marketing start
- 2019-10-24
- Substance
- VARDENAFIL
- Active strength
- 5 mg/1
- Pharmacologic classes
- Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Vardenafil Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| VARDENAFIL | 5 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | UCE6F4125H |
| Rxcui | 349478, 349479, 349480, 402273 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f2f15561-f1f1-39f4-fff4-873c88c535cd | Product name | 4 | 20210224 |
| 9c8b57d3-6030-411c-8a17-97b4b8f0ea17 | Product name | 3 | 20200708 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 33342-152-07 | Vardenafil Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | 5 | |
| 33342-152-11 | Vardenafil Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | 5 | |
| 33342-152-12 | Vardenafil Hydrochloride | 10 in 1 BLISTER PACK | TABLET | 10 | 5 | |
| 33342-152-12 | Vardenafil Hydrochloride | 10 in 1 CARTON | TABLET | 10 | 5 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 349480 | vardenafil 20 MG Oral Tablet | PSN | a38de6e1-21ca-4ebe-a3c7-6f849cf8b675 | 5 |
| 349478 | vardenafil 5 MG Oral Tablet | PSN | a38de6e1-21ca-4ebe-a3c7-6f849cf8b675 | 5 |
| 349479 | vardenafil HCl 10 MG Oral Tablet | PSN | a38de6e1-21ca-4ebe-a3c7-6f849cf8b675 | 5 |
| 402273 | vardenafil HCl 2.5 MG Oral Tablet | PSN | a38de6e1-21ca-4ebe-a3c7-6f849cf8b675 | 5 |
| 349479 | vardenafil 10 MG Oral Tablet | SCD | a38de6e1-21ca-4ebe-a3c7-6f849cf8b675 | 5 |
| 402273 | vardenafil 2.5 MG Oral Tablet | SCD | a38de6e1-21ca-4ebe-a3c7-6f849cf8b675 | 5 |
| 349480 | vardenafil 20 MG Oral Tablet | SCD | a38de6e1-21ca-4ebe-a3c7-6f849cf8b675 | 5 |
| 349478 | vardenafil 5 MG Oral Tablet | SCD | a38de6e1-21ca-4ebe-a3c7-6f849cf8b675 | 5 |
| 349479 | vardenafil 10 MG (vardenafil HCl 11.85 MG) Oral Tablet | SY | a38de6e1-21ca-4ebe-a3c7-6f849cf8b675 | 5 |
| 402273 | vardenafil 2.5 MG (vardenafil hydrochloride 2.96 MG) Oral Tablet | SY | a38de6e1-21ca-4ebe-a3c7-6f849cf8b675 | 5 |
| 349480 | vardenafil 20 MG (vardenafil HCl 23.7 MG) Oral Tablet | SY | a38de6e1-21ca-4ebe-a3c7-6f849cf8b675 | 5 |
| 349478 | vardenafil 5 MG (vardenafil hydrochloride 5.926 MG) Oral Tablet | SY | a38de6e1-21ca-4ebe-a3c7-6f849cf8b675 | 5 |
| 349480 | vardenafil 20 MG Oral Tablet | PSN | db63310a-37f3-202b-e053-2995a90a5520 | 2 |
| 349478 | vardenafil 5 MG Oral Tablet | PSN | db63310a-37f3-202b-e053-2995a90a5520 | 2 |
| 349479 | vardenafil HCl 10 MG Oral Tablet | PSN | db63310a-37f3-202b-e053-2995a90a5520 | 2 |
| 402273 | vardenafil HCl 2.5 MG Oral Tablet | PSN | db63310a-37f3-202b-e053-2995a90a5520 | 2 |
| 349479 | vardenafil 10 MG Oral Tablet | SCD | db63310a-37f3-202b-e053-2995a90a5520 | 2 |
| 402273 | vardenafil 2.5 MG Oral Tablet | SCD | db63310a-37f3-202b-e053-2995a90a5520 | 2 |
| 349480 | vardenafil 20 MG Oral Tablet | SCD | db63310a-37f3-202b-e053-2995a90a5520 | 2 |
| 349478 | vardenafil 5 MG Oral Tablet | SCD | db63310a-37f3-202b-e053-2995a90a5520 | 2 |
| 349479 | vardenafil 10 MG (vardenafil HCl 11.85 MG) Oral Tablet | SY | db63310a-37f3-202b-e053-2995a90a5520 | 2 |
| 402273 | vardenafil 2.5 MG (vardenafil hydrochloride 2.96 MG) Oral Tablet | SY | db63310a-37f3-202b-e053-2995a90a5520 | 2 |
| 349480 | vardenafil 20 MG (vardenafil HCl 23.7 MG) Oral Tablet | SY | db63310a-37f3-202b-e053-2995a90a5520 | 2 |
| 349478 | vardenafil 5 MG (vardenafil hydrochloride 5.926 MG) Oral Tablet | SY | db63310a-37f3-202b-e053-2995a90a5520 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 33342-152-07 | 33342015207 | 30 TABLET in 1 BOTTLE (33342-152-07) | 30 tablet | 2019-10-24 | 0000-00-00 | No | No | Current |
| 33342-152-11 | 33342015211 | 100 TABLET in 1 BOTTLE (33342-152-11) | 100 tablet | 2019-10-24 | 0000-00-00 | No | No | Current |
| 33342-152-12 | 33342015212 | 10 BLISTER PACK in 1 CARTON (33342-152-12) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2019-10-24 | 0000-00-00 | No | No | Current |