SPL MEDGUIDE SECTION
Manufactured by:
Cadila Healthcare Ltd.
India
NAPROXEN TABLETS
- Manufacturer
- Zydus Lifesciences Limited
- Effective date
- 2024-11-30
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 6
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 20:47:41
Label at a glance#
ProductNaproxen
Active ingredientNAPROXEN
Label structure2 sections
Label contents#
Full prescribing information#
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-676-01
Naproxen tablets, 250 mg
100 Tablets
Rx only
NDC 65841-677-01
Naproxen tablets, 375 mg
100 Tablets
Rx only
NDC 65841-678-01
Naproxen tablets, 500 mg
100 Tablets
Rx only
Products#
Every source-derived product name is available through these pages.
- Naproxen
- CROSCARMELLOSE SODIUM
- FERRIC OXIDE YELLOW
- MAGNESIUM STEARATE
- POVIDONE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 65841-676 | 65841-676-01, 65841-676-10 |
| 65841-677 | 65841-677-01, 65841-677-05, 65841-677-10 |
| 65841-678 | 65841-678-01, 65841-678-05, 65841-678-10 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| NAPROXEN | 57Y76R9ATQ | ACTIB |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| FERRIC OXIDE YELLOW | EX438O2MRT | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| POVIDONE | FZ989GH94E | IACT |
| NAPROXEN | 57Y76R9ATQ | ACTIB |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| FERRIC OXIDE YELLOW | EX438O2MRT | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| POVIDONE | FZ989GH94E | IACT |
| NAPROXEN | 57Y76R9ATQ | ACTIB |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| FERRIC OXIDE YELLOW | EX438O2MRT | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| POVIDONE | FZ989GH94E | IACT |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078620-001 | NAPROXEN | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-06-07 | |
| A078620-002 | NAPROXEN | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-06-07 | |
| A078620-003 | NAPROXEN | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-06-07 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078620-001 | AB |
| A078620-002 | AB |
| A078620-003 | 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 | A078620-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-06-07 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A078620-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-06-07 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A078620-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-06-07 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A078620-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-06-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078620-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-06-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078620-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-06-07 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A078620-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-06-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078620-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-06-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078620-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-06-07 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078620-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-06-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078620-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-06-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078620-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-06-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078620-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-06-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078620-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-06-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078620-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-06-07 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078620-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-06-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078620-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-06-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078620-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-06-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078620-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-06-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078620-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-06-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078620-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-06-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078620-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-06-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078620-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-06-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078620-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-06-07 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078620-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-06-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078620-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-06-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078620-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-06-07 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078620-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-06-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078620-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-06-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078620-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-06-07 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078620-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-06-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078620-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-06-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078620-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-06-07 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078620-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-06-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078620-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-06-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078620-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-06-07 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078620-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-06-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078620-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-06-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078620-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-06-07 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078620-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-06-07 | 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 | A078620-001 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A078620-002 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A078620-003 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A078620-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078620-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078620-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A078620-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078620-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078620-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078620-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078620-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078620-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078620-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078620-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078620-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078620-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078620-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078620-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078620-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078620-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078620-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078620-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078620-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078620-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078620-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078620-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078620-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078620-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078620-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078620-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078620-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078620-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078620-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078620-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078620-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078620-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078620-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078620-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078620-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078620-001 | AB | 1 | 79d66fd596c7… |
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 |
|---|---|---|---|---|---|---|
| 6bfff86f-dde8-4e5d-887f-82d5b4255aab | 94e84499-d536-457c-96e6-7569e8a179c4 | 2025-04-29 | 94e84499-d536-457c-96e6-7569e8a179c4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.