SPL MEDGUIDE
Manufactured by:
Cadila Healthcare Ltd.
India.
Manufactured by:
Cadila Healthcare Ltd.
India.
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 65841-637 | DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED] | 8 | Legacy NDC | 20250409_4f40e035-fdad-42c9-bd31-c1582215f83e.zip |
| 65841-638 | DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED] | 8 | Legacy NDC | 20250409_4f40e035-fdad-42c9-bd31-c1582215f83e.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| DIVALPROEX SODIUM | ACTIVE INGREDIENT | 644VL95AO6 | 1 | |
| VALPROIC ACID | ACTIVE MOIETY | 614OI1Z5WI | 1 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 65841-637 | 65841-637-14, 65841-637-16, 65841-637-01, 65841-637-05 |
| 65841-638 | 65841-638-16, 65841-638-01, 65841-638-05 |
Every source-derived ingredient row is available through these pages.
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION / OPHTHALMIC | 0.5 %w/w | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, ORALLY DISINTEGRATING / ORAL | 80 mg | ||
| TALC | TALC | 7SEV7J4R1U | PELLET / ORAL | 69 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | POWDER, FOR SUSPENSION / ORAL | 600 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET / ORAL | 232 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE / ORAL | 729 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | ENEMA / RECTAL | 150 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE / ORAL | 254 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER, FOR SUSPENSION / ORAL | 120 mg | ||
| HYDROXYPROPYL CELLULOSE | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | TABLET, COATED / ORAL | 13.6 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SYSTEM / TRANSDERMAL | 35 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, EXTENDED RELEASE / ORAL | 119.7 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, DELAYED RELEASE / ORAL | 40 mg | ||
| HYDROXYPROPYL CELLULOSE | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | FILM, EXTENDED RELEASE / TRANSDERMAL | 19 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / TOPICAL | 6 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, EXTENDED RELEASE / ORAL | 5119 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION / ORAL | 305 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, DELAYED RELEASE / ORAL | 66 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION / ORAL | 360 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / ORAL | 2 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SYSTEM / TOPICAL | 420 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SOAP / TOPICAL | 1 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / ORAL | 602 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GRANULE, FOR SUSPENSION / ORAL | 143 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SYSTEM / INTRAVITREAL | 0.02 mg | ||
| POLYVINYL ALCOHOL | POLYVINYL ALCOHOL | 532B59J990 | CAPSULE / ORAL | 1.67 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | GEL / RECTAL | 348 mg | ||
| HYDROXYPROPYL CELLULOSE | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | SOLUTION / TOPICAL | 200 mg | ||
| TALC | TALC | 7SEV7J4R1U | GRANULE, FOR SUSPENSION / ORAL | 296 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, LIQUID FILLED / ORAL | 12 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | PELLET / ORAL | 24 mg | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | POWDER, FOR SUSPENSION / ORAL | 39 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | GRANULE, FOR SUSPENSION / ORAL | 450 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / SUBLINGUAL | 17.5 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED / ORAL | 3 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, COATED PELLETS / ORAL | 14 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, ORALLY DISINTEGRATING / ORAL | 41 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION / RECTAL | 452 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, ORALLY DISINTEGRATING / ORAL | 0.15 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SUSPENSION, EXTENDED RELEASE / ORAL | 71 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / ORAL | 300 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | DROPS / ORAL | NA | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, FOR SUSPENSION / ORAL | 24 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 9 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, DELAYED RELEASE / ORAL | 349 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CREAM / TOPICAL | 80 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, COATED / ORAL | 320.75 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | INSERT / VAGINAL | 8 mg | ||
| TALC | TALC | 7SEV7J4R1U | SUSPENSION / ORAL | 234 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / TOPICAL | 104 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 2350 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, SUGAR COATED / ORAL | NA | ||
| POLYVINYL ALCOHOL | POLYVINYL ALCOHOL | 532B59J990 | TABLET, ORALLY DISINTEGRATING / ORAL | 2 mg | ||
| POLYVINYL ALCOHOL | POLYVINYL ALCOHOL | 532B59J990 | SOLUTION/ DROPS / OPHTHALMIC | 1.4 %w/v | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / RESPIRATORY (INHALATION) | 2 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / BUCCAL | 11 mg | ||
| POLYVINYL ALCOHOL | POLYVINYL ALCOHOL | 532B59J990 | SUSPENSION/ DROPS / OPHTHALMIC | 1.4 %w/v | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / ORAL | 1000 mg |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078239-001 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-27 | |
| A078239-002 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-04 |
| Application-product | TE code |
|---|---|
| A078239-001 | AB |
| A078239-002 | AB |
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 | A078239-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-27 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A078239-002 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-04 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A078239-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078239-002 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-04 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A078239-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078239-002 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-04 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078239-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078239-002 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-04 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078239-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078239-002 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-04 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078239-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078239-002 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-04 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078239-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078239-002 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-04 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078239-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078239-002 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-04 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078239-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078239-002 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-04 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078239-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078239-002 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-04 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078239-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078239-002 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-04 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078239-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078239-002 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-04 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078239-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078239-002 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-04 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078239-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-27 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078239-002 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-04 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078239-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-27 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078239-002 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-04 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078239-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-27 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078239-002 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-04 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078239-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-27 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078239-002 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-04 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078239-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-27 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078239-002 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-04 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A078239-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-27 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A078239-002 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-04 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A078239-001 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-27 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A078239-002 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-04 | 4b0b4de00fa7… |
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A078239-001 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A078239-002 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A078239-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078239-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A078239-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078239-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078239-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078239-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078239-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078239-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078239-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078239-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078239-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078239-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078239-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078239-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078239-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078239-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078239-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078239-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078239-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078239-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078239-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078239-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078239-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078239-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078239-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078239-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078239-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078239-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078239-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078239-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A078239-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A078239-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078239-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078239-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A078239-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A078239-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A078239-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A078239-002 | AB | 1 | 4b0b4de00fa7… |
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 |
|---|---|---|---|---|---|---|
| 26712420-739a-4027-8db7-f73d832efbeb | 4f40e035-fdad-42c9-bd31-c1582215f83e | 2025-09-19 | 4f40e035-fdad-42c9-bd31-c1582215f83e |
Adverse event summaries are temporarily unavailable. Other product information remains available.