TAGAMET
- Product NDC
- 52183-223
- Requested package NDC
- 52183-223-30
- 11-digit product format
- 521830223
- Labeler code
- 52183
- Product ID
- 52183-223_e042ef55-48d2-43c6-91d1-55becd1f9f7c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- cimetidine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Prestige Brands Holdings, Inc.
- Application
- NDA020238
- Marketing category
- NDA
- Marketing start
- 2023-02-01
- Substance
- CIMETIDINE
- Active strength
- 200 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020238-001 | TAGAMET HB | CIMETIDINE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-06-19 | |
| N020238-002 | TAGAMET HB | CIMETIDINE | 200MG | TABLET / ORAL | RLD, RS | 1996-08-21 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N020238-001 | TAGAMET HB | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-06-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020238-002 | TAGAMET HB | 200MG | TABLET / ORAL | RLD, RS | 1996-08-21 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N020238-001 | TAGAMET HB | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-06-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020238-002 | TAGAMET HB | 200MG | TABLET / ORAL | RLD, RS | 1996-08-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020238-001 | TAGAMET HB | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-06-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020238-002 | TAGAMET HB | 200MG | TABLET / ORAL | RLD, RS | 1996-08-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020238-001 | TAGAMET HB | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-06-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020238-002 | TAGAMET HB | 200MG | TABLET / ORAL | RLD, RS | 1996-08-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020238-001 | TAGAMET HB | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-06-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020238-002 | TAGAMET HB | 200MG | TABLET / ORAL | RLD, RS | 1996-08-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020238-001 | TAGAMET HB | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-06-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020238-002 | TAGAMET HB | 200MG | TABLET / ORAL | RLD, RS | 1996-08-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020238-001 | TAGAMET HB | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-06-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020238-002 | TAGAMET HB | 200MG | TABLET / ORAL | RLD, RS | 1996-08-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020238-001 | TAGAMET HB | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-06-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020238-002 | TAGAMET HB | 200MG | TABLET / ORAL | RLD, RS | 1996-08-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020238-001 | TAGAMET HB | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-06-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020238-002 | TAGAMET HB | 200MG | TABLET / ORAL | RLD, RS | 1996-08-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020238-001 | TAGAMET HB | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-06-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020238-002 | TAGAMET HB | 200MG | TABLET / ORAL | RLD, RS | 1996-08-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020238-001 | TAGAMET HB | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-06-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020238-002 | TAGAMET HB | 200MG | TABLET / ORAL | RLD, RS | 1996-08-21 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020238-001 | TAGAMET HB | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-06-19 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020238-002 | TAGAMET HB | 200MG | TABLET / ORAL | RLD, RS | 1996-08-21 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020238-001 | TAGAMET HB | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-06-19 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020238-002 | TAGAMET HB | 200MG | TABLET / ORAL | RLD, RS | 1996-08-21 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020238-001 | TAGAMET HB | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-06-19 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020238-002 | TAGAMET HB | 200MG | TABLET / ORAL | RLD, RS | 1996-08-21 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020238-001 | TAGAMET HB | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-06-19 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020238-002 | TAGAMET HB | 200MG | TABLET / ORAL | RLD, RS | 1996-08-21 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020238-001 | TAGAMET HB | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-06-19 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020238-002 | TAGAMET HB | 200MG | TABLET / ORAL | RLD, RS | 1996-08-21 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020238-001 | TAGAMET HB | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-06-19 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020238-002 | TAGAMET HB | 200MG | TABLET / ORAL | RLD, RS | 1996-08-21 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020238-001 | TAGAMET HB | 100MG | TABLET / ORAL | RLD | 1995-06-19 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020238-002 | TAGAMET HB | 200MG | TABLET / ORAL | RLD, RS | 1996-08-21 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020238-001 | TAGAMET HB | 100MG | TABLET / ORAL | RLD | 1995-06-19 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020238-002 | TAGAMET HB | 200MG | TABLET / ORAL | RLD, RS | 1996-08-21 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020238-001 | TAGAMET HB | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1995-06-19 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020238-002 | TAGAMET HB | 200MG | TABLET / ORAL | RLD, RS | 1996-08-21 | 74a2ff9319b5… |
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
- TAGAMET
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CIMETIDINE | 200 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 80061L1WGD | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| c8ba8815-9d99-439f-b397-3869f729d9f4 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 8f48ba86-02a3-4def-9efa-3a8140fd7adf | Product name | 2 | 20250624 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52183-223-30 | TAGAMET | 10 in 1 BLISTER PACK | TABLET | 10 | 1 | |
| 52183-223-30 | TAGAMET | 3 in 1 BOX | TABLET | 3 | 1 |
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 |
|---|---|---|---|---|---|---|
| Tagamet | CIMETIDINE | Medtech Products Inc. | e6401e0a-8612-42e8-bf89-2d67243f28dc | 2024-06-10 | Warnings | 020238 NDA020238 |
| TAGAMET | CIMETIDINE | Prestige Brands Holdings, Inc. | c8ba8815-9d99-439f-b397-3869f729d9f4 | 2023-01-20 | Warnings | 020238 NDA020238 52183-223-30 52183-223 52183022330 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197505 | cimetidine 200 MG Oral Tablet | PSN | c8ba8815-9d99-439f-b397-3869f729d9f4 | 1 |
| 104062 | Tagamet HB 200 MG Oral Tablet | PSN | c8ba8815-9d99-439f-b397-3869f729d9f4 | 1 |
| 104062 | cimetidine 200 MG Oral Tablet [Tagamet] | SBD | c8ba8815-9d99-439f-b397-3869f729d9f4 | 1 |
| 197505 | cimetidine 200 MG Oral Tablet | SCD | c8ba8815-9d99-439f-b397-3869f729d9f4 | 1 |
| 104062 | Tagamet 200 MG Oral Tablet | SY | c8ba8815-9d99-439f-b397-3869f729d9f4 | 1 |
| 104062 | Tagamet HB 200 MG Oral Tablet | SY | c8ba8815-9d99-439f-b397-3869f729d9f4 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 52183-223-30 | 52183022330 | 3 BLISTER PACK in 1 BOX (52183-223-30) / 10 TABLET in 1 BLISTER PACK | 3 blister pack | 2023-02-01 | No | No | Current |