Famotidine
- Product NDC
- 55111-118
- 11-digit product format
- 551110118
- Labeler code
- 55111
- Product ID
- 55111-118_e818465f-a1ca-0e6a-f18c-cf2cb2a2cc82
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Famotidine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Dr.Reddys Laboratories Limited
- Application
- ANDA077367
- Marketing category
- ANDA
- Marketing start
- 2006-09-30
- Substance
- FAMOTIDINE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [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 | 55111-118 | UNFINISHED | Active or certified unfinished drug listing | 2026-08-17 | ||
| unfinished package | package | 55111-118 | 55111-118-98 | UNFINISHED | Active or certified unfinished drug listing | 2026-08-17 |
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 | 55111-118-98 | 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 | 55111-118-98 | 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 | 55111-118-98 | 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 | 55111-118-98 | 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 | 55111-118-98 | 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 | 55111-118-98 | 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 | 55111-118-98 | 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 | 55111-118-98 | 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 | 55111-118-98 | 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 | 55111-118-98 | 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 | 55111-118-98 | 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 | 55111-118-98 | 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 | 55111-118-98 | 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 | 55111-118-98 | 50b4072663b7… | eae3003ed65e… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | unfinished product | product | 906f6e251498… | bf70b80e44f0… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | unfinished package | package | 55111-118-98 | 906f6e251498… | bf70b80e44f0… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | unfinished product | product | 6db9cb8d1e19… | 3449e1ec5b70… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | unfinished package | package | 55111-118-98 | 6db9cb8d1e19… | 3449e1ec5b70… |
| 2021-02-18 23:40 UTC · source 2021-02-18 | unfinished product | product | 8fc7167e32ce… | e96bbc724034… | |
| 2021-02-18 23:40 UTC · source 2021-02-18 | unfinished package | package | 55111-118-98 | 8fc7167e32ce… | e96bbc724034… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | unfinished product | product | 4184dd79f89f… | 545327b3e20f… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | unfinished package | package | 55111-118-98 | 4184dd79f89f… | 545327b3e20f… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077367-001 | FAMOTIDINE | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | ||
| A077367-002 | FAMOTIDINE | FAMOTIDINE | 10MG | TABLET / ORAL | 2001-08-17 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A077367-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077367-002 | FAMOTIDINE | 10MG | TABLET / ORAL | 2001-08-17 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077367-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077367-002 | FAMOTIDINE | 10MG | TABLET / ORAL | 2001-08-17 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077367-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077367-002 | FAMOTIDINE | 10MG | TABLET / ORAL | 2001-08-17 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077367-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077367-002 | FAMOTIDINE | 10MG | TABLET / ORAL | 2001-08-17 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077367-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077367-002 | FAMOTIDINE | 10MG | TABLET / ORAL | 2001-08-17 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077367-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077367-002 | FAMOTIDINE | 10MG | TABLET / ORAL | 2001-08-17 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077367-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077367-002 | FAMOTIDINE | 10MG | TABLET / ORAL | 2001-08-17 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077367-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077367-002 | FAMOTIDINE | 10MG | TABLET / ORAL | 2001-08-17 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077367-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077367-002 | FAMOTIDINE | 10MG | TABLET / ORAL | 2001-08-17 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077367-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077367-002 | FAMOTIDINE | 10MG | TABLET / ORAL | 2001-08-17 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077367-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077367-002 | FAMOTIDINE | 10MG | TABLET / ORAL | 2001-08-17 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077367-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077367-002 | FAMOTIDINE | 10MG | TABLET / ORAL | 2001-08-17 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077367-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077367-002 | FAMOTIDINE | 10MG | TABLET / ORAL | 2001-08-17 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077367-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077367-002 | FAMOTIDINE | 10MG | TABLET / ORAL | 2001-08-17 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077367-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077367-002 | FAMOTIDINE | 10MG | TABLET / ORAL | 2001-08-17 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077367-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077367-002 | FAMOTIDINE | 10MG | TABLET / ORAL | 2001-08-17 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077367-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077367-002 | FAMOTIDINE | 10MG | TABLET / ORAL | 2001-08-17 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077367-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077367-002 | FAMOTIDINE | 10MG | TABLET / ORAL | 2001-08-17 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A077367-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A077367-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A077367-002 | FAMOTIDINE | 10MG | TABLET / ORAL | 2001-08-17 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A077367-001 | FAMOTIDINE | 20MG | TABLET / ORAL | 2006-09-25 | 782e0a99824c… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Famotidine
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FAMOTIDINE | 10 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5QZO15J2Z8 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 387088a6-8eaa-fc49-8050-a546d0f0fd32 | Available on FDA.report |
DailyMed Product Concepts#
| 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 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| 4fdc761c-585e-054b-8ebe-86130a26e4c1 | Product name | 2 | 20221205 |
| fc2e1e31-353a-2c24-a4b4-fcf93bf7e38e | Product name | 1 | 20140508 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55111-118-90 | EA - Each | 55111-118 | b0358378-0ed2-4912-b058-89e7e6d918f7 | 1 | 2021-04-08 |
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 |
|---|---|---|---|---|---|---|
| Famotidine | FAMOTIDINE | Chain Drug Marketing Association INC | 7fbc5e10-30c6-7f8d-1040-d48a80fe4d79 | 2025-07-22 | Warnings | 077367 ANDA077367 |
| Acid Reducer Original Strength | FAMOTIDINE | Dr.Reddys Laboratories Inc. | ca039876-f7e5-3e60-da5a-a1f40637a417 | 2025-07-17 | Warnings | 077367 ANDA077367 |
| Famotidine | FAMOTIDINE | Albertsons Companies | 27314f55-5e31-703c-b98c-ec89bf308472 | 2025-07-17 | Warnings | 077367 ANDA077367 |
| Famotidine | FAMOTIDINE | Family Dollar Stores, Inc. | 0f81e8ac-ddad-13d6-e883-6a5310e058de | 2025-07-17 | Warnings | 077367 ANDA077367 |
| Famotidine | FAMOTIDINE | Discount Drug Mart, Inc | c5d81352-c45b-3ea1-9974-8a096bd05009 | 2025-07-17 | Warnings | 077367 ANDA077367 |
| Famotidine | FAMOTIDINE | Chain Drug Consortium, LLC | 937f7bce-955b-9418-5aed-2e84aee50de3 | 2025-07-17 | Warnings | 077367 ANDA077367 |
| Famotidine | FAMOTIDINE | Chain Drug Marketing Association INC | 1d78bc9e-cf7b-8853-c6dc-b36e5de4dd0a | 2025-07-17 | Warnings | 077367 ANDA077367 |
| Famotidine | FAMOTIDINE | Dr.Reddys Laboratories Limited | 387088a6-8eaa-fc49-8050-a546d0f0fd32 | 2025-06-03 | Warnings | 077367 ANDA077367 55111-118 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55111-118-04 | 55111011804 | 1 BOTTLE in 1 CARTON (55111-118-04) / 120 TABLET in 1 BOTTLE | 1 bottle | 2020-10-01 | 0000-00-00 | No | No | Current |
| 55111-118-12 | 55111011812 | 1 BLISTER PACK in 1 CARTON (55111-118-12) / 12 TABLET in 1 BLISTER PACK | 1 blister pack | 2006-09-30 | 0000-00-00 | No | No | Current |
| 55111-118-18 | 55111011818 | 1 BOTTLE in 1 CARTON (55111-118-18) / 180 TABLET in 1 BOTTLE | 1 bottle | 2006-09-30 | 0000-00-00 | No | No | Current |
| 55111-118-24 | 55111011824 | 4 BLISTER PACK in 1 CARTON (55111-118-24) / 6 TABLET in 1 BLISTER PACK | 4 blister pack | 2006-09-30 | 0000-00-00 | No | No | Current |
| 55111-118-30 | 55111011830 | 1 BOTTLE in 1 CARTON (55111-118-30) / 30 TABLET in 1 BOTTLE | 1 bottle | 2006-09-30 | 0000-00-00 | No | No | Current |
| 55111-118-35 | 55111011835 | 3 BLISTER PACK in 1 CARTON (55111-118-35) / 6 TABLET in 1 BLISTER PACK | 3 blister pack | 2006-09-30 | 0000-00-00 | No | No | Current |
| 55111-118-40 | 55111011840 | 1 BOTTLE in 1 CARTON (55111-118-40) / 40 TABLET in 1 BOTTLE | 1 bottle | 2020-10-01 | 0000-00-00 | No | No | Current |
| 55111-118-60 | 55111011860 | 1 BOTTLE in 1 CARTON (55111-118-60) / 60 TABLET in 1 BOTTLE | 1 bottle | 2006-09-30 | 0000-00-00 | No | No | Current |
| 55111-118-79 | 55111011879 | 1 BLISTER PACK in 1 CARTON (55111-118-79) / 10 TABLET in 1 BLISTER PACK | 1 blister pack | 2006-09-30 | 0000-00-00 | No | No | Current |
| 55111-118-81 | 55111011881 | 3 BLISTER PACK in 1 CARTON (55111-118-81) / 10 TABLET in 1 BLISTER PACK | 3 blister pack | 2006-09-30 | 0000-00-00 | No | No | Current |
| 55111-118-90 | 55111011890 | 1 BOTTLE in 1 CARTON (55111-118-90) / 90 TABLET in 1 BOTTLE | 1 bottle | 2006-09-30 | 0000-00-00 | No | No | Current |
| 55111-118-98 | 55111011898 | 20000 TABLET in 1 POUCH (55111-118-98) | 20000 tablet | 09-OCT-20 | Current |