Tadalafil
- Product NDC
- 70934-795
- Requested package NDC
- 70934-795-15
- 11-digit product format
- 709340795
- Labeler code
- 70934
- Product ID
- 70934-795_b710c227-8195-c2a1-e053-2995a90aca6f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Denton Pharma, Inc. DBA Northwind Pharmaceuticals
- Application
- ANDA209167
- Marketing category
- ANDA
- Marketing start
- 2020-10-16
- Marketing end
- 0000-00-00
- Substance
- TADALAFIL
- Active strength
- 20 mg/1
- Pharmacologic classes
- Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 package | package | 70934-795 | 70934-795-15 | 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 |
|---|---|---|---|---|---|---|---|
| A209167-001 | TADALAFIL | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2019-03-26 | |
| A209167-002 | TADALAFIL | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2019-03-26 | |
| A209167-003 | TADALAFIL | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2019-10-23 | |
| A209167-004 | TADALAFIL | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2019-03-26 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A209167-001 | AB1 |
| A209167-002 | AB1 |
| A209167-003 | AB1 |
| A209167-004 | 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 | A209167-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2019-03-26 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A209167-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2019-03-26 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A209167-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2019-10-23 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A209167-004 | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2019-03-26 | 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 | A209167-001 | AB1 | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A209167-002 | AB1 | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A209167-003 | AB1 | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A209167-004 | 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 |
|---|---|---|---|---|---|---|
| Tadalafil | TADALAFIL | Bryant Ranch Prepack | 07567ae5-7345-4ab1-9b2c-c586c4da0427 | 2026-06-24 | Warnings, Adverse reactions | 209167 ANDA209167 |
| Tadalafil | TADALAFIL | Bryant Ranch Prepack | aa8d165b-0c7d-497a-b56a-7c62ebc0a5d2 | 2026-05-13 | Warnings, Adverse reactions | 209167 ANDA209167 |
| Tadalafil | TADALAFIL | Bryant Ranch Prepack | f8def23c-55ea-4796-9735-dbcb25104835 | 2026-05-13 | Warnings, Adverse reactions | 209167 ANDA209167 |
| Tadalafil | TADALAFIL | Accord Healthcare Inc. | eedf3ad9-7d40-496d-b1a9-6200010c18e1 | 2026-04-16 | Warnings, Adverse reactions | 209167 ANDA209167 |
| Tadalafil | TADALAFIL | Preferred Pharmaceuticals Inc. | affacb88-4af3-4ce9-961b-7fc37b169e9a | 2026-01-12 | Warnings, Adverse reactions | 209167 ANDA209167 |
| Tadalafil | TADALAFIL | Northwind Health Company, LLC | f3092f5a-b976-91ab-e053-2995a90a9b50 | 2026-01-01 | Warnings, Adverse reactions | 209167 ANDA209167 |
| Tadalafil | TADALAFIL | Northwind Health Company, LLC | f317fe1e-d7c4-fb8b-e053-2a95a90a5445 | 2026-01-01 | Warnings, Adverse reactions | 209167 ANDA209167 |
| Tadalafil | TADALAFIL | NuCare Pharmaceuticals,Inc. | cf35291b-b05b-1182-e053-2995a90a8dee | 2025-02-10 | Warnings, Adverse reactions | 209167 ANDA209167 |
| Tadalafil | TADALAFIL | NuCare Pharmaceuticals,Inc. | 9f83ea2e-8ee8-ab6d-e053-2995a90a1e96 | 2024-06-20 | Warnings, Adverse reactions | 209167 ANDA209167 |
| Tadalafil | TADALAFIL | NuCare Pharmaceuticals,Inc. | a0acad71-8ae3-2827-e053-2995a90a20b3 | 2024-06-20 | Warnings, Adverse reactions | 209167 ANDA209167 |
| Tadalafil | TADALAFIL | Proficient Rx LP | 7a105ef9-7129-4ce1-bd8d-ae316bf348e2 | 2022-11-01 | Warnings, Adverse reactions | 209167 ANDA209167 |
| Tadalafil | TADALAFIL | Proficient Rx LP | b539e862-d5d4-4989-a3dd-1eba66285d53 | 2022-05-01 | Warnings, Adverse reactions | 209167 ANDA209167 |
| Tadalafil | TADALAFIL | Proficient Rx LP | 31c05a53-7282-46d0-81bd-108defe6fb38 | 2022-04-01 | Warnings, Adverse reactions | 209167 ANDA209167 |
| Tadalafil | TADALAFIL | Proficient Rx LP | 6fa9d4fa-86c9-4791-b28b-78e8b9341cea | 2022-04-01 | Warnings, Adverse reactions | 209167 ANDA209167 |
| Tadalafil | TADALAFIL | Asclemed USA, Inc. | aba646fe-70c2-1abb-e053-2995a90aa16d | 2022-01-28 | Warnings, Adverse reactions | 209167 ANDA209167 |
FDA-Initiated Inactive NDC Indexing#
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70934-795-15 | 70934079515 | 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-795-15) | 2020-10-16 | 0000-00-00 | No | No | Current |