Naproxen
- Product NDC
- 76420-264
- Requested package NDC
- 76420-264-01
- 11-digit product format
- 764200264
- Labeler code
- 76420
- Product ID
- 76420-264_327a22dc-b87a-2758-e063-6394a90ae257
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA212517
- Marketing category
- ANDA
- Marketing start
- 2020-03-01
- Substance
- NAPROXEN
- Active strength
- 500 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
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A212517-001 | NAPROXEN | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | |
| A212517-002 | NAPROXEN | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | |
| A212517-003 | NAPROXEN | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A212517-001 | AB |
| A212517-002 | AB |
| A212517-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A212517-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A212517-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A212517-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A212517-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A212517-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A212517-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212517-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212517-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212517-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212517-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212517-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212517-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212517-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212517-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212517-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212517-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212517-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212517-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212517-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212517-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212517-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212517-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212517-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212517-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A212517-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A212517-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | 79d66fd596c7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A212517-001 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A212517-002 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A212517-003 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A212517-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A212517-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A212517-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A212517-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A212517-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A212517-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A212517-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212517-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212517-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212517-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212517-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212517-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A212517-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212517-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212517-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212517-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212517-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212517-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212517-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212517-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212517-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212517-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212517-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212517-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212517-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212517-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212517-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212517-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212517-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212517-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212517-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212517-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212517-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A212517-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A212517-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A212517-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212517-001 | AB | 1 | 79d66fd596c7… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Naproxen
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| NAPROXEN | 500 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 57Y76R9ATQ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 198014 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1e406e47-408a-48cc-921e-52882a11581c | 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 |
|---|---|---|---|---|---|---|
| 76420-264-01 | Naproxen | 1 in 1 BOTTLE | TABLET | 1 | 4 | |
| 76420-264-02 | Naproxen | 2 in 1 BOTTLE | TABLET | 2 | 4 | |
| 76420-264-05 | Naproxen | 500 in 1 BOTTLE | TABLET | 500 | 4 | |
| 76420-264-07 | Naproxen | 7 in 1 BOTTLE | TABLET | 7 | 4 | |
| 76420-264-10 | Naproxen | 100 in 1 BOTTLE | TABLET | 100 | 4 | |
| 76420-264-12 | Naproxen | 120 in 1 BOTTLE | TABLET | 120 | 4 | |
| 76420-264-14 | Naproxen | 14 in 1 BOTTLE | TABLET | 14 | 4 | |
| 76420-264-20 | Naproxen | 20 in 1 BOTTLE | TABLET | 20 | 4 | |
| 76420-264-30 | Naproxen | 30 in 1 BOTTLE | TABLET | 30 | 4 | |
| 76420-264-60 | Naproxen | 60 in 1 BOTTLE | TABLET | 60 | 4 | |
| 76420-264-90 | Naproxen | 90 in 1 BOTTLE | TABLET | 90 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 76420-264-01 | EA - Each | 76420-264 | 25290b1e-9603-4e54-a9aa-fe29038d6179 | 1 | 2023-04-07 |
| 76420-264-02 | EA - Each | 76420-264 | 7515f579-ac17-470d-9989-8f762c02562b | 1 | 2023-04-07 |
| 76420-264-05 | EA - Each | 76420-264 | 7fda6185-53b6-4201-a628-7da24bc42e84 | 1 | 2023-04-07 |
| 76420-264-07 | EA - Each | 76420-264 | 0826323d-9074-4baa-9792-a7748f50e31f | 1 | 2023-05-05 |
| 76420-264-10 | EA - Each | 76420-264 | 0472d120-105c-4329-a354-261012f72483 | 1 | 2023-04-07 |
| 76420-264-14 | EA - Each | 76420-264 | 0ce12fab-2c5d-47f8-95fc-85edf308dc66 | 1 | 2023-04-07 |
| 76420-264-30 | EA - Each | 76420-264 | 18795363-1adf-4eb4-a419-0cb227da0edf | 1 | 2023-04-07 |
| 76420-264-60 | EA - Each | 76420-264 | 5bbcabb3-fa77-454e-9215-343827320bd1 | 1 | 2023-04-07 |
| 76420-264-90 | EA - Each | 76420-264 | 28fc4f60-e874-44f0-a2de-76dd413262bc | 1 | 2023-04-07 |
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 | NAPROXEN | Northwind Health Company, LLC | c986ba9a-6f48-8347-e053-2a95a90aa1c1 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | PHOENIX RX LLC | 43912294-77c9-eda8-e063-6394a90adf0a | 2025-11-14 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | A-S Medication Solutions | 8c3398bd-66b1-4a14-8aaa-e4a2d6749a08 | 2025-11-02 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | Medcore LLC | 129392c8-8ce1-4b78-8863-042db880095f | 2025-10-28 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | A-S Medication Solutions | cfa88511-40bb-4658-b606-44c68d0746b7 | 2025-10-08 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | A-S Medication Solutions | b500bdba-946a-41ff-855c-1f2937547d01 | 2025-10-08 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | Proficient Rx LP | e64b3b36-f96e-463e-aca8-8f6e86724bcf | 2025-07-01 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | A-S Medication Solutions | 7fef9311-471b-472c-b4f2-c952a2b3a255 | 2025-05-07 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | Asclemed USA, Inc. | 1e406e47-408a-48cc-921e-52882a11581c | 2025-04-11 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 76420-264-01 76420-264 76420026401 |
| Naproxen | NAPROXEN | Direct_Rx | f499a207-02c8-a338-e053-2995a90accc0 | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | Advanced Rx Pharmacy of Tennessee, LLC | d292f376-1844-b01c-e053-2a95a90a0927 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | Quality Care Products, LLC | 1acfb8cc-6faf-4b3e-9304-4819c42de0a6 | 2024-12-18 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | Advanced Rx Pharmacy of Tennessee, LLC | 1431b769-5535-78d6-e063-6394a90a8423 | 2024-03-21 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | Asclemed USA, Inc. | 5a48c0d4-37bf-4c26-a9a7-5c67ff2adb4b | 2024-03-19 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | Medsource Pharmaceuticals | 12648efc-3be8-a915-e063-6394a90a3620 | 2024-02-27 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | Bryant Ranch Prepack | 1cdcaba5-5550-40f6-94cc-b0a98cc17d3c | 2024-01-11 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | Bryant Ranch Prepack | d564f52d-171c-4e7d-974c-3a0e192e6c12 | 2024-01-11 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | Proficient Rx LP | d0670241-f1f9-4fdf-83d4-547e7b800811 | 2022-11-01 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | Aphena Pharma Solutions - Tennessee, LLC | 98efdeb8-ea38-456e-953f-ba589727f284 | 2021-11-10 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | Aphena Pharma Solutions - Tennessee, LLC | 9c963e77-6e05-47d0-a8d3-e581777377b9 | 2021-08-19 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198014 | naproxen 500 MG Oral Tablet | PSN | 1e406e47-408a-48cc-921e-52882a11581c | 4 |
| 198014 | naproxen 500 MG Oral Tablet | SCD | 1e406e47-408a-48cc-921e-52882a11581c | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 76420-264-01 | 76420026401 | 1 TABLET in 1 BOTTLE (76420-264-01) | 1 tablet | 2022-08-17 | 0000-00-00 | No | No | Current |