Indications and uses
relieves heartburn associated with acid indigestion and sour stomach prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages
relieves heartburn associated with acid indigestion and sour stomach prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages
For Famotidine 10 mg: adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. to prevent symptoms, swallow 1 tablet with a glass of water at any time from 15 to 60 minutes before eating food or drinking beverages that cause heartburn do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor For Famotidine 20 mg: adults and chil...
read the directions and warnings before use keep the carton. It contains important information. store at 20°-25°C (68°-77°F) protect from moisture
Famotidine USP, 10 mg/20 mg
Acid reducer
Allergy alert: Do not use if you are allergic to famotidine or other acid reducers
Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
For Famotidine 10 mg:
For Famotidine 20 mg:
Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, talc, and titanium dioxide
Please call Ascent Pharmaceuticals, Inc. at 1-855-221-1622 (toll-free number)
Tips for Managing Heartburn
| Class | Version | Type | Effective |
|---|---|---|---|
| FAMOTIDINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 396bde5c-c78e-2f8b-ab1f-2ee6ba32bcae | Product name | 7 | 20260317 |
| 1e73f975-1ce7-705e-2bcf-788b1b5e24ba | Product name | 5 | 20251124 |
| cf645750-2e70-f6e1-c05a-a52847def5dd | Product name | 9 | 20250312 |
| 4fdc761c-585e-054b-8ebe-86130a26e4c1 | Product name | 2 | 20221205 |
| fc2e1e31-353a-2c24-a4b4-fcf93bf7e38e | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43602-511-03 | FAMOTIDINE | 300 in 1 BOTTLE | TABLET | 300 | 3 | |
| 43602-511-03 | FAMOTIDINE | 1 in 1 CARTON | TABLET | 1 | 3 | |
| 43602-511-30 | FAMOTIDINE | 30 in 1 BOTTLE | TABLET | 30 | 3 | |
| 43602-511-30 | FAMOTIDINE | 1 in 1 CARTON | TABLET | 1 | 3 | |
| 43602-602-03 | FAMOTIDINE | 1 in 1 CARTON | TABLET | 1 | 3 | |
| 43602-602-03 | FAMOTIDINE | 300 in 1 BOTTLE | TABLET | 300 | 3 | |
| 43602-602-30 | FAMOTIDINE | 30 in 1 BOTTLE | TABLET | 30 | 3 | |
| 43602-602-30 | FAMOTIDINE | 1 in 1 CARTON | TABLET | 1 | 3 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 43602-511 | FAMOTIDINE TABLET [ASCENT PHARMACEUTICALS, INC.] | 3 | Current NDC, Legacy NDC, 4 package rows | 20220218_b481dd30-7d64-43ec-85d4-2289db62cad7.zip |
| 43602-602 | FAMOTIDINE TABLET [ASCENT PHARMACEUTICALS, INC.] | 3 | Current NDC, Legacy NDC, 4 package rows | 20220218_b481dd30-7d64-43ec-85d4-2289db62cad7.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 43602-511 | 43602-511-30, 43602-511-03 |
| 43602-602 | 43602-602-30, 43602-602-03 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|---|
| A216030-001 | FAMOTIDINE | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-03 | ||
| A216030-002 | FAMOTIDINE | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-03 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A216030-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-03 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A216030-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-03 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A216030-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-03 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A216030-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-03 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A216030-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-03 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A216030-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-03 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216030-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-03 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216030-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-03 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A216030-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-03 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A216030-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-03 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216030-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-03 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216030-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-03 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216030-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-03 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216030-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-03 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216030-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-03 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216030-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-03 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216030-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-03 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216030-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-03 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216030-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-03 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216030-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-03 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216030-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-03 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216030-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-03 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A216030-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-03 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A216030-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-03 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216030-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-03 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216030-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-03 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216030-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-03 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216030-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-03 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216030-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-03 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216030-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-03 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A216030-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-03 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A216030-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-03 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A216030-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-03 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A216030-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-03 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A216030-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-03 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A216030-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-03 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A216030-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-03 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A216030-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-03 | 4b0b4de00fa7… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A216030-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2021-11-03 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A216030-002 | FAMOTIDINE | 20MG | TABLET / ORAL | 2021-11-03 | bb7c543d1eb4… |
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 |
|---|---|---|---|---|---|---|
| FAMOTIDINE | FAMOTIDINE | Ascent Pharmaceuticals, Inc. | b481dd30-7d64-43ec-85d4-2289db62cad7 | 2022-02-14 | Warnings | 43602-602-30 43602-602-03 43602-511-30 43602-511-03 43602-602 43602-511 43602060203 43602051130 43602051103 43602060230 a2adad08-283e-4617-b3db-1eade7f5b296 b481dd30-7d64-43ec-85d4-2289db62cad7 |
Adverse event summaries are temporarily unavailable. Other product information remains available.