Vienva TM
- Product NDC
- 70518-1325
- 11-digit product format
- 705181325
- Labeler code
- 70518
- Product ID
- 70518-1325_9242c70c-d26e-c71b-e053-2a95a90a78ec
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levonorgestrel and Ethinyl Estradiol
- Dosage form
- KIT
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA201088
- Marketing category
- ANDA
- Marketing start
- 2018-07-26
- Marketing end
- 0000-00-00
- Active strength
- 0
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 70518-1325 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 70518-1325 | 70518-1325-0 | D | Discontinued by firm | 2026-07-31 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A201088-001 | VIENVA | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG;0.1MG | TABLET / ORAL-28 | AB1 | 2015-05-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A201088-001 | AB1 |
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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A201088-001 | VIENVA | 0.02MG;0.1MG | TABLET / ORAL-28 | AB1 | 2015-05-21 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A201088-001 | AB1 | 1 | a50c72e98297… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| VIENVA TM | LEVONORGESTREL AND ETHINYL ESTRADIOL | A-S Medication Solutions | f6825c1a-ba78-47aa-9622-12e59517ab1a | 2026-03-03 | Warnings, Adverse reactions | 201088 ANDA201088 |
| Vienva TM | LEVONORGESTREL AND ETHINYL ESTRADIOL | Bryant Ranch Prepack | 8b1b92f7-b736-436d-b06d-1fedeb970408 | 2024-12-17 | Warnings, Adverse reactions | 201088 ANDA201088 |
| Vienva | LEVONORGESTREL AND ETHINYL ESTRADIOL | Xiromed, LLC. | 58ea31df-f9cf-7d00-c2db-0529fb9a3e53 | 2024-11-11 | Warnings, Adverse reactions | 201088 ANDA201088 |