Naproxen Sodium
- Product NDC
- 55111-273
- 11-digit product format
- 551110273
- Labeler code
- 55111
- Product ID
- 55111-273_45f79372-39c7-ae59-c119-51aece645ae0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Naproxen Sodium
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Dr.Reddy's Laboratories Limited
- Application
- ANDA075168
- Marketing category
- ANDA
- Marketing start
- 1998-07-29
- Substance
- NAPROXEN SODIUM
- Active strength
- 220 mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 |
|---|---|---|---|---|---|---|---|
| unfinished product | product | 55111-273 | UNFINISHED | Active or certified unfinished drug listing | 2026-08-07 | ||
| unfinished package | package | 55111-273 | 55111-273-95 | UNFINISHED | Active or certified unfinished drug listing | 2026-08-07 |
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 21:27 UTC · source 2025-12-05 | unfinished product | product | a6255e0c9aa5… | a0211a219f2e… | |
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 55111-273-95 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished product | product | 1d862106b807… | 00c93037cd84… | |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 55111-273-95 | 1d862106b807… | 00c93037cd84… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished product | product | 390b4c401c3f… | 2c692c2daee3… | |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 55111-273-95 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished product | product | e30019b0c005… | a3f0b14938b7… | |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 55111-273-95 | e30019b0c005… | a3f0b14938b7… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished product | product | bbbc9f937eca… | 946b9c97cf81… | |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 55111-273-95 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished product | product | f268b84574a6… | 26285f5ac5df… | |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 55111-273-95 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished product | product | f764e8902f78… | 92046438deef… | |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished package | package | 55111-273-95 | f764e8902f78… | 92046438deef… |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished product | product | 68b1e3bced9e… | 98a755eb8bc6… | |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished package | package | 55111-273-95 | 68b1e3bced9e… | 98a755eb8bc6… |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished product | product | 05c55d027831… | ca05dca9dc4c… | |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished package | package | 55111-273-95 | 05c55d027831… | ca05dca9dc4c… |
| 2024-11-09 02:36 UTC · source 2024-11-08 | unfinished product | product | 48b4f40e6753… | c7c7a00d2afa… | |
| 2024-11-09 02:36 UTC · source 2024-11-08 | unfinished package | package | 55111-273-95 | 48b4f40e6753… | c7c7a00d2afa… |
| 2024-10-09 02:27 UTC · source 2024-10-08 | unfinished product | product | 27f29a85d7e4… | 1372111e901f… | |
| 2024-10-09 02:27 UTC · source 2024-10-08 | unfinished package | package | 55111-273-95 | 27f29a85d7e4… | 1372111e901f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | unfinished product | product | 8d62ce987f31… | 9fe9ef23e30d… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | unfinished package | package | 55111-273-95 | 8d62ce987f31… | 9fe9ef23e30d… |
| 2024-05-28 21:11 UTC · source 2024-05-28 | unfinished product | product | d1e113ab4d42… | 063ee3eb0a1d… | |
| 2024-05-28 21:11 UTC · source 2024-05-28 | unfinished package | package | 55111-273-95 | d1e113ab4d42… | 063ee3eb0a1d… |
| 2024-05-15 03:51 UTC · source 2024-05-14 | unfinished product | product | 50b4072663b7… | eae3003ed65e… | |
| 2024-05-15 03:51 UTC · source 2024-05-14 | unfinished package | package | 55111-273-95 | 50b4072663b7… | eae3003ed65e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075168-001 | NAPROXEN SODIUM | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1998-07-28 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A075168-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1998-07-28 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075168-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1998-07-28 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075168-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1998-07-28 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075168-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1998-07-28 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075168-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1998-07-28 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075168-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1998-07-28 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075168-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1998-07-28 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075168-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1998-07-28 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075168-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1998-07-28 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A075168-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1998-07-28 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075168-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1998-07-28 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075168-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1998-07-28 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075168-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1998-07-28 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A075168-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1998-07-28 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075168-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1998-07-28 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A075168-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1998-07-28 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A075168-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1998-07-28 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A075168-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1998-07-28 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A075168-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1998-07-28 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A075168-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1998-07-28 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075168-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1998-07-28 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A075168-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1998-07-28 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A075168-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1998-07-28 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A075168-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1998-07-28 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A075168-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1998-07-28 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A075168-001 | NAPROXEN SODIUM | EQ 200MG BASE | TABLET / ORAL | 1998-07-28 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A075168-001 | NAPROXEN SODIUM | EQ 200MG BASE | TABLET / ORAL | 1998-07-28 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A075168-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1998-07-28 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A075168-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1998-07-28 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A075168-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1998-07-28 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A075168-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1998-07-28 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A075168-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1998-07-28 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A075168-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1998-07-28 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A075168-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1998-07-28 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A075168-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1998-07-28 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A075168-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1998-07-28 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A075168-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1998-07-28 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A075168-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1998-07-28 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A075168-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1998-07-28 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A075168-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1998-07-28 | cb3db0bc1861… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Naproxen Sodium
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| NAPROXEN SODIUM | 220 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9TN87S3A3C | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 849574 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| aca5d497-fbc6-464d-2dee-25c50e11bc78 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fef6ad89-235f-4274-ba49-a8e53642473e | Product name | 2 | 20250225 |
| 87fed3e6-8fba-48ef-96b0-3a7fb54b96ff | Product name | 3 | 20230306 |
| b5fdaaec-7251-4da6-9cb2-4e9e76939ec8 | Product name | 1 | 20200623 |
| e76dbbc1-775d-722c-08ff-ed45e8a80def | Product name | 3 | 20181002 |
| 6f4f4521-fd56-1ae6-888b-3b021bd75c7c | Product name | 1 | 20140508 |
| ce67e27d-1d21-5465-4409-b0662dd99d4d | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55111-273-01 | Naproxen Sodium | 1 in 1 CARTON | TABLET, COATED | 1 | 13 | |
| 55111-273-01 | Naproxen Sodium | 100 in 1 BOTTLE | TABLET, COATED | 100 | 13 | |
| 55111-273-02 | Naproxen Sodium | 200 in 1 BOTTLE | TABLET, COATED | 200 | 13 | |
| 55111-273-02 | Naproxen Sodium | 1 in 1 CARTON | TABLET, COATED | 1 | 13 | |
| 55111-273-05 | Naproxen Sodium | 1 in 1 CARTON | TABLET, COATED | 1 | 13 | |
| 55111-273-05 | Naproxen Sodium | 500 in 1 BOTTLE | TABLET, COATED | 500 | 13 | |
| 55111-273-24 | Naproxen Sodium | 1 in 1 CARTON | TABLET, COATED | 1 | 13 | |
| 55111-273-24 | Naproxen Sodium | 24 in 1 BOTTLE | TABLET, COATED | 24 | 13 | |
| 55111-273-40 | Naproxen Sodium | 1 in 1 CARTON | TABLET, COATED | 1 | 13 | |
| 55111-273-40 | Naproxen Sodium | 400 in 1 BOTTLE | TABLET, COATED | 400 | 13 | |
| 55111-273-50 | Naproxen Sodium | 50 in 1 BOTTLE | TABLET, COATED | 50 | 13 | |
| 55111-273-50 | Naproxen Sodium | 1 in 1 CARTON | TABLET, COATED | 1 | 13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Naproxen Sodium Caplets | NAPROXEN SODIUM | Dr Reddy's Laboratories Inc | ee0463bc-e939-1ecf-5a86-d045c426fecf | 2025-07-22 | Warnings | 075168 ANDA075168 |
| Naproxen Sodium Headache Pain Caplets | NAPROXEN SODIUM | Dr.Reddy's Laboratories Inc | 605ca130-88aa-27d5-330c-6d9c95987f1f | 2025-07-22 | Warnings | 075168 ANDA075168 |
| Naproxen Sodium | NAPROXEN SODIUM | SAM'S WEST INC | 7a87a339-4482-ec9e-3c77-7ccb9cea2c4c | 2025-07-22 | Warnings | 075168 ANDA075168 |
| Naproxen Sodium | NAPROXEN SODIUM | Kroger Company | 30bcf289-0039-f389-73c4-fef3e8861034 | 2025-07-22 | Warnings | 075168 ANDA075168 |
| Naproxen Sodium | NAPROXEN SODIUM | Dr.Reddy's Laboratories Limited | aca5d497-fbc6-464d-2dee-25c50e11bc78 | 2025-06-03 | Warnings | 075168 ANDA075168 55111-273 |
| Naproxen Sodium Headache Pain | NAPROXEN SODIUM | Dr.Reddy's Laboratories Inc | 12e45b43-eca2-73f4-1d68-07d4238f8c70 | 2025-06-03 | Warnings | 075168 ANDA075168 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 849574 | naproxen sodium 220 MG Oral Tablet | PSN | aca5d497-fbc6-464d-2dee-25c50e11bc78 | 13 |
| 849574 | naproxen sodium 220 MG Oral Tablet | SCD | aca5d497-fbc6-464d-2dee-25c50e11bc78 | 13 |
| 849574 | naproxen sodium 220 MG (as naproxen 200 MG) Oral Tablet | SY | aca5d497-fbc6-464d-2dee-25c50e11bc78 | 13 |
| 849574 | naproxen sodium 220 MG Oral Tablet | PSN | 7a87a339-4482-ec9e-3c77-7ccb9cea2c4c | 4 |
| 849574 | naproxen sodium 220 MG Oral Tablet | SCD | 7a87a339-4482-ec9e-3c77-7ccb9cea2c4c | 4 |
| 849574 | naproxen sodium 220 MG (as naproxen 200 MG) Oral Tablet | SY | 7a87a339-4482-ec9e-3c77-7ccb9cea2c4c | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55111-273-01 | 55111027301 | 1 BOTTLE in 1 CARTON (55111-273-01) / 100 TABLET, COATED in 1 BOTTLE | 1 bottle | 1998-07-29 | 0000-00-00 | No | No | Current |
| 55111-273-02 | 55111027302 | 1 BOTTLE in 1 CARTON (55111-273-02) / 200 TABLET, COATED in 1 BOTTLE | 1 bottle | 1998-07-29 | 0000-00-00 | No | No | Current |
| 55111-273-05 | 55111027305 | 1 BOTTLE in 1 CARTON (55111-273-05) / 500 TABLET, COATED in 1 BOTTLE | 1 bottle | 1998-07-29 | 0000-00-00 | No | No | Current |
| 55111-273-24 | 55111027324 | 1 BOTTLE in 1 CARTON (55111-273-24) / 24 TABLET, COATED in 1 BOTTLE | 1 bottle | 1998-07-29 | 0000-00-00 | No | No | Current |
| 55111-273-40 | 55111027340 | 1 BOTTLE in 1 CARTON (55111-273-40) / 400 TABLET, COATED in 1 BOTTLE | 1 bottle | 1998-07-29 | 0000-00-00 | No | No | Current |
| 55111-273-50 | 55111027350 | 1 BOTTLE in 1 CARTON (55111-273-50) / 50 TABLET, COATED in 1 BOTTLE | 1 bottle | 1998-07-29 | 0000-00-00 | No | No | Current |
| 55111-273-95 | 55111027395 | 5000 TABLET, COATED in 1 POUCH (55111-273-95) | 29-JUL-98 | Current |