Tadalafil
- Product NDC
- 71335-1334
- Requested package NDC
- 71335-1334-1
- 11-digit product format
- 713351334
- Labeler code
- 71335
- Product ID
- 71335-1334_e1c4f116-c21a-4686-b59c-29324986e57e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA209908
- Marketing category
- ANDA
- Marketing start
- 2019-03-26
- Marketing end
- 0000-00-00
- Substance
- TADALAFIL
- Active strength
- 10 mg/1
- Pharmacologic classes
- Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
- 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 package | package | 71335-1334 | 71335-1334-1 | 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 |
|---|---|---|---|---|---|---|---|
| A209908-001 | TADALAFIL | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2019-03-26 | |
| A209908-002 | TADALAFIL | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2019-03-26 | |
| A209908-003 | TADALAFIL | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2019-03-26 | |
| A209908-004 | TADALAFIL | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2019-03-26 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A209908-001 | AB1 |
| A209908-002 | AB1 |
| A209908-003 | AB1 |
| A209908-004 | 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 | A209908-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2019-03-26 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A209908-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2019-03-26 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A209908-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2019-03-26 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A209908-004 | 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 | A209908-001 | AB1 | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A209908-002 | AB1 | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A209908-003 | AB1 | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A209908-004 | 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 | NuCare Pharmaceutical,Inc. | 48850075-ac57-abb7-e063-6394a90a7881 | 2026-01-16 | Warnings, Adverse reactions | 209908 ANDA209908 |
| Tadalafil | TADALAFIL | NuCare Pharmaceuticals, Inc. | 48892acb-43bb-a4d8-e063-6394a90a5d61 | 2026-01-16 | Warnings, Adverse reactions | 209908 ANDA209908 |
| Tadalafil | TADALAFIL | XLCare Pharmaceuticals Inc. | add6afb8-d38c-47a2-8c35-d5940667bb0c | 2024-12-09 | Warnings, Adverse reactions | 209908 ANDA209908 |
| Tadalafil | TADALAFIL | A-S Medication Solutions | b9d71483-861b-465b-846b-d7bfd6cbac11 | 2023-12-26 | Warnings, Adverse reactions | 209908 ANDA209908 |
| Tadalafil | TADALAFIL | A-S Medication Solutions | c1c8feb4-a85a-4f39-8c44-bc9cd77226f4 | 2023-12-21 | Warnings, Adverse reactions | 209908 ANDA209908 |
| Tadalafil | TADALAFIL | Camber Pharmaceuticals, Inc. | a3892605-4eb1-4d6e-a675-f7f7d4302f38 | 2019-03-26 | Warnings, Adverse reactions | 209908 ANDA209908 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 71335-1334-1 | 71335133401 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1334-1) | 2019-03-26 | 0000-00-00 | No | No | Current |