Allopurinol
- Product NDC
- 60760-114
- 11-digit product format
- 607600114
- Labeler code
- 60760
- Product ID
- 60760-114_7b324564-ca99-7c37-e053-2a91aa0a2616
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ALLOPURINOL
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- St Marys Medical Park Pharmacy
- Application
- ANDA075798
- Marketing category
- ANDA
- Marketing start
- 2013-04-25
- Marketing end
- 2019-04-30
- Substance
- ALLOPURINOL
- Active strength
- 100 mg/1
- Pharmacologic classes
- Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 | 60760-114 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 60760-114 | 60760-114-30 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 60760-114 | 60760-114-90 | 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 |
|---|---|---|---|---|---|---|---|
| A075798-001 | ALLOPURINOL | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2003-06-27 | |
| A075798-002 | ALLOPURINOL | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2003-06-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075798-001 | AB |
| A075798-002 | AB |
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 | A075798-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2003-06-27 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A075798-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2003-06-27 | 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 | A075798-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A075798-002 | AB | 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 |
|---|---|---|---|---|---|---|
| Allopurinol | ALLOPURINOL | Cardinal Health 107, LLC | b6c5b5c0-b1cb-44c0-a849-5d317e6fa300 | 2026-07-21 | Warnings, Adverse reactions | 075798 ANDA075798 |
| Allopurinol | ALLOPURINOL | Major Pharmaceuticals | 8c0f5af5-a453-4641-933f-ccb2625fca39 | 2026-06-24 | Warnings, Adverse reactions | 075798 ANDA075798 |
| Allopurinol | ALLOPURINOL | NCS HealthCare of KY, LLC dba Vangard Labs | 1da7d9d4-ed94-4fe6-827a-6f4b3bdce3c3 | 2026-01-23 | Warnings, Adverse reactions | 075798 ANDA075798 |
| Allopurinol | ALLOPURINOL | REMEDYREPACK INC. | 4dbced9a-ef6f-455e-8d5d-b635409521db | 2025-10-01 | Warnings, Adverse reactions | 075798 ANDA075798 |
| Allopurinol | ALLOPURINOL | Bryant Ranch Prepack | 73a374a6-ea1a-40a1-b6eb-d42654df0895 | 2024-07-08 | Boxed warning, Warnings, Adverse reactions | 075798 ANDA075798 |
| Allopurinol | ALLOPURINOL | Bryant Ranch Prepack | f91c2183-e41d-45bc-87aa-edfca5eebac5 | 2024-07-08 | Boxed warning, Warnings, Adverse reactions | 075798 ANDA075798 |
| Allopurinol | ALLOPURINOL | Bryant Ranch Prepack | 005048dd-844f-468c-bf56-1a09727e3477 | 2024-07-08 | Boxed warning, Warnings, Adverse reactions | 075798 ANDA075798 |
| Allopurinol | ALLOPURINOL | Bryant Ranch Prepack | 90912dd4-5abf-4fd3-8fc1-3afd057b743f | 2024-04-08 | Boxed warning, Warnings, Adverse reactions | 075798 ANDA075798 |
| Allopurinol | ALLOPURINOL | Bryant Ranch Prepack | e84cd8df-79d8-449f-ace2-5a4de1cdaf51 | 2024-04-08 | Boxed warning, Warnings, Adverse reactions | 075798 ANDA075798 |
| Allopurinol | ALLOPURINOL | Par Health USA, LLC | fbac3b4f-dc23-4359-ac3f-2b3fdde41af2 | 2024-01-30 | Warnings, Adverse reactions | 075798 ANDA075798 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60760-114-30 | EA - Each | 60760-114 | 1a2acad0-0c90-4112-94a6-467caa057c2a | 1 | 2013-05-02 |
| 60760-114-90 | EA - Each | 60760-114 | eff849c8-36b0-47f1-b0a9-23fc7bc04451 | 1 | 2015-10-02 |