Allopurinol
- Product NDC
- 16714-042
- 11-digit product format
- 167140042
- Labeler code
- 16714
- Product ID
- 16714-042_049208c7-7904-4d26-92ac-d78d4179e3ca
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Allopurinol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Northstar RxLLC
- Application
- ANDA078253
- Marketing category
- ANDA
- Marketing start
- 2009-11-16
- Marketing end
- 0000-00-00
- Substance
- ALLOPURINOL
- Active strength
- 300 mg/1
- Pharmacologic classes
- Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 16714-042 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 16714-042 | 16714-042-07 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 16714-042 | 16714-042-10 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 16714-042 | 16714-042-11 | D | Discontinued by firm | 2026-08-17 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 16714-042-11 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 16714-042-10 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 16714-042-07 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 16714-042-11 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 16714-042-10 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 16714-042-07 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 16714-042-11 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 16714-042-10 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 16714-042-07 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 16714-042-11 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 16714-042-10 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 16714-042-07 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 16714-042-11 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 16714-042-10 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 16714-042-07 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 16714-042-11 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 16714-042-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 16714-042-07 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 16714-042-10 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 16714-042-10 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 16714-042-10 | 0efc9e666f02… | f202fb6c5f17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078253-001 | ALLOPURINOL | ALLOPURINOL | 100MG | TABLET / ORAL | 2007-09-11 | ||
| A078253-002 | ALLOPURINOL | ALLOPURINOL | 300MG | TABLET / ORAL | 2007-09-11 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A078253-001 | ALLOPURINOL | 100MG | TABLET / ORAL | 2007-09-11 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078253-002 | ALLOPURINOL | 300MG | TABLET / ORAL | 2007-09-11 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078253-001 | ALLOPURINOL | 100MG | TABLET / ORAL | 2007-09-11 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078253-002 | ALLOPURINOL | 300MG | TABLET / ORAL | 2007-09-11 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078253-001 | ALLOPURINOL | 100MG | TABLET / ORAL | 2007-09-11 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078253-002 | ALLOPURINOL | 300MG | TABLET / ORAL | 2007-09-11 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078253-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2007-09-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078253-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2007-09-11 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078253-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2007-09-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078253-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2007-09-11 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078253-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2007-09-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078253-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2007-09-11 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078253-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2007-09-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078253-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2007-09-11 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078253-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2007-09-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078253-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2007-09-11 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078253-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2007-09-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078253-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2007-09-11 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078253-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2007-09-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078253-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2007-09-11 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078253-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2007-09-11 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078253-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2007-09-11 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078253-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2007-09-11 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078253-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2007-09-11 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078253-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2007-09-11 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078253-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2007-09-11 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078253-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2007-09-11 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078253-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2007-09-11 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078253-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2007-09-11 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078253-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2007-09-11 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078253-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2007-09-11 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078253-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2007-09-11 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A078253-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2007-09-11 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A078253-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2007-09-11 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A078253-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2007-09-11 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A078253-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2007-09-11 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A078253-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2007-09-11 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A078253-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2007-09-11 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A078253-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2007-09-11 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A078253-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2007-09-11 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-08-23 18:47 UTC | 2025-08 | A078253-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078253-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078253-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078253-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078253-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078253-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078253-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078253-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078253-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078253-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078253-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078253-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078253-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078253-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078253-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078253-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078253-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078253-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078253-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078253-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078253-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078253-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A078253-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A078253-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078253-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078253-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A078253-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A078253-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A078253-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A078253-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A078253-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A078253-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A078253-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A078253-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A078253-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A078253-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A078253-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A078253-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A078253-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A078253-002 | AB | 1 | 5aa47cf7b7d7… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0ee55bab-4ea8-ac26-c688-380cfbcd5c03 | Product name | 7 | 20260127 |
| de89a493-168f-43fa-9852-1f15e00dbb17 | Product name | 1 | 20221110 |
| 4a2a34d6-1853-423b-9e0c-360370b95802 | Product name | 1 | 20171006 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 16714-042-01 | EA - Each | 16714-042 | 38412c78-fd0a-4c1f-a334-bc89715f5334 | 1 | 2012-07-24 |
| 16714-042-04 | EA - Each | 16714-042 | d5563278-e405-4f3b-aa4c-49193f0adb30 | 1 | 2012-07-24 |
| 16714-042-05 | EA - Each | 16714-042 | 6495f224-0975-44ac-bbf2-8cf0a7577658 | 1 | 2012-07-24 |
| 16714-042-07 | EA - Each | 16714-042 | c41ebba7-b09b-43e9-b8c9-f5a06c7b4bb2 | 1 | 2013-12-02 |
| 16714-042-10 | EA - Each | 16714-042 | 3b0b7183-5f51-4883-b04c-6fbd57100dc0 | 1 | 2013-12-02 |
| 16714-042-11 | EA - Each | 16714-042 | cec45d35-f89c-45f9-8436-e51e7f8875b7 | 1 | 2013-12-02 |
DailyMed Socrata Ingredients#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197320 | allopurinol 300 MG Oral Tablet | PSN | d5801a33-4d2c-e78c-e053-2a95a90acb13 | 1 |
| 197320 | allopurinol 300 MG Oral Tablet | SCD | d5801a33-4d2c-e78c-e053-2a95a90acb13 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 16714-042-07 | 16714004207 | 30 TABLET in 1 BOTTLE (16714-042-07) | 30 tablet | 2009-11-16 | 0000-00-00 | No | No | Current |
| 16714-042-10 | 16714004210 | 100 TABLET in 1 BOTTLE (16714-042-10) | 100 tablet | 2009-11-16 | 0000-00-00 | No | No | Current |
| 16714-042-11 | 16714004211 | 500 TABLET in 1 BOTTLE (16714-042-11) | 500 tablet | 2009-11-16 | 0000-00-00 | No | No | Current |