Cimetidine
- Product NDC
- 55289-581
- Requested package NDC
- 55289-581-30
- 11-digit product format
- 552890581
- Labeler code
- 55289
- Product ID
- 55289-581_419aec97-c220-0c91-e063-6294a90a67b0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cimetidine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA074246
- Marketing category
- ANDA
- Marketing start
- 1994-05-17
- Substance
- CIMETIDINE
- Active strength
- 400 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 |
|---|---|---|---|---|---|---|---|
| A074246-001 | CIMETIDINE | CIMETIDINE | 200MG | TABLET / ORAL | AB | 1994-05-17 | |
| A074246-002 | CIMETIDINE | CIMETIDINE | 300MG | TABLET / ORAL | AB | 1994-05-17 | |
| A074246-003 | CIMETIDINE | CIMETIDINE | 400MG | TABLET / ORAL | AB | 1994-05-17 | |
| A074246-004 | CIMETIDINE | CIMETIDINE | 800MG | TABLET / ORAL | AB | RS | 1994-05-17 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A074246-001 | AB |
| A074246-002 | AB |
| A074246-003 | AB |
| A074246-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A074246-001 | CIMETIDINE | 200MG | TABLET / ORAL | AB | 1994-05-17 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A074246-002 | CIMETIDINE | 300MG | TABLET / ORAL | AB | 1994-05-17 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A074246-003 | CIMETIDINE | 400MG | TABLET / ORAL | AB | 1994-05-17 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A074246-004 | CIMETIDINE | 800MG | TABLET / ORAL | AB | RS | 1994-05-17 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A074246-001 | CIMETIDINE | 200MG | TABLET / ORAL | AB | 1994-05-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A074246-002 | CIMETIDINE | 300MG | TABLET / ORAL | AB | 1994-05-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A074246-003 | CIMETIDINE | 400MG | TABLET / ORAL | AB | 1994-05-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A074246-004 | CIMETIDINE | 800MG | TABLET / ORAL | AB | RS | 1994-05-17 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A074246-001 | CIMETIDINE | 200MG | TABLET / ORAL | AB | 1994-05-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A074246-002 | CIMETIDINE | 300MG | TABLET / ORAL | AB | 1994-05-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A074246-003 | CIMETIDINE | 400MG | TABLET / ORAL | AB | 1994-05-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A074246-004 | CIMETIDINE | 800MG | TABLET / ORAL | AB | RS | 1994-05-17 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074246-001 | CIMETIDINE | 200MG | TABLET / ORAL | AB | 1994-05-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074246-002 | CIMETIDINE | 300MG | TABLET / ORAL | AB | 1994-05-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074246-003 | CIMETIDINE | 400MG | TABLET / ORAL | AB | 1994-05-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074246-004 | CIMETIDINE | 800MG | TABLET / ORAL | AB | RS | 1994-05-17 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A074246-001 | CIMETIDINE | 200MG | TABLET / ORAL | AB | 1994-05-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A074246-002 | CIMETIDINE | 300MG | TABLET / ORAL | AB | 1994-05-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A074246-003 | CIMETIDINE | 400MG | TABLET / ORAL | AB | 1994-05-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A074246-004 | CIMETIDINE | 800MG | TABLET / ORAL | AB | RS | 1994-05-17 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074246-001 | CIMETIDINE | 200MG | TABLET / ORAL | AB | 1994-05-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074246-002 | CIMETIDINE | 300MG | TABLET / ORAL | AB | 1994-05-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074246-003 | CIMETIDINE | 400MG | TABLET / ORAL | AB | 1994-05-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074246-004 | CIMETIDINE | 800MG | TABLET / ORAL | AB | RS | 1994-05-17 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074246-001 | CIMETIDINE | 200MG | TABLET / ORAL | AB | 1994-05-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074246-002 | CIMETIDINE | 300MG | TABLET / ORAL | AB | 1994-05-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074246-003 | CIMETIDINE | 400MG | TABLET / ORAL | AB | 1994-05-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074246-004 | CIMETIDINE | 800MG | TABLET / ORAL | AB | RS | 1994-05-17 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074246-001 | CIMETIDINE | 200MG | TABLET / ORAL | AB | 1994-05-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074246-002 | CIMETIDINE | 300MG | TABLET / ORAL | AB | 1994-05-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074246-003 | CIMETIDINE | 400MG | TABLET / ORAL | AB | 1994-05-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074246-004 | CIMETIDINE | 800MG | TABLET / ORAL | AB | RS | 1994-05-17 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074246-001 | CIMETIDINE | 200MG | TABLET / ORAL | AB | 1994-05-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074246-002 | CIMETIDINE | 300MG | TABLET / ORAL | AB | 1994-05-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074246-003 | CIMETIDINE | 400MG | TABLET / ORAL | AB | 1994-05-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074246-004 | CIMETIDINE | 800MG | TABLET / ORAL | AB | RS | 1994-05-17 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074246-001 | CIMETIDINE | 200MG | TABLET / ORAL | AB | 1994-05-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074246-002 | CIMETIDINE | 300MG | TABLET / ORAL | AB | 1994-05-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074246-003 | CIMETIDINE | 400MG | TABLET / ORAL | AB | 1994-05-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074246-004 | CIMETIDINE | 800MG | TABLET / ORAL | AB | RS | 1994-05-17 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A074246-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A074246-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A074246-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A074246-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A074246-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A074246-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A074246-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A074246-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A074246-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A074246-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A074246-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A074246-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074246-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074246-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074246-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074246-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A074246-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A074246-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A074246-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A074246-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074246-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074246-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074246-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074246-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074246-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074246-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074246-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074246-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074246-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074246-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074246-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074246-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074246-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074246-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074246-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074246-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074246-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074246-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074246-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074246-004 | AB | 1 | 5bbf6a4d5a75… |
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
- Cimetidine
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CIMETIDINE | 400 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 80061L1WGD | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 197507 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 28fd7158-a617-436a-8f5c-71ffbaafe527 | 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 |
|---|---|---|---|---|---|---|
| 55289-581-10 | Cimetidine | 10 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 10 | 13 | |
| 55289-581-20 | Cimetidine | 20 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 20 | 13 | |
| 55289-581-30 | Cimetidine | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | 13 | |
| 55289-581-60 | Cimetidine | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | 13 | |
| 55289-581-90 | Cimetidine | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | 13 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55289-581-10 | EA - Each | 55289-581 | 4de6bce8-5292-4dcd-9c39-d56e62910bb2 | 1 | 2012-07-24 |
| 55289-581-20 | EA - Each | 55289-581 | f33b34dd-917b-48ab-b03c-22d669e38837 | 1 | 2012-07-24 |
| 55289-581-30 | EA - Each | 55289-581 | fa390290-26df-43f4-8f80-816d9db2a909 | 1 | 2012-07-24 |
| 55289-581-60 | EA - Each | 55289-581 | acb3ce1a-e9f3-482c-96b2-c6c05c0b3142 | 1 | 2012-07-24 |
| 55289-581-90 | EA - Each | 55289-581 | b789d56f-a6e0-419e-b4b2-113382dad25c | 1 | 2012-07-24 |
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 |
|---|---|---|---|---|---|---|
| Cimetidine | CIMETIDINE | Mylan Pharmaceuticals Inc. | 06c0a509-026f-44e0-9975-a94a8de51d43 | 2026-07-15 | Adverse reactions | 074246 ANDA074246 |
| Cimetidine | CIMETIDINE | Northwind Health Company, LLC | db482bd8-e68d-3a38-e053-2995a90a38a5 | 2026-01-01 | Adverse reactions | 074246 ANDA074246 |
| Cimetidine | CIMETIDINE | PD-Rx Pharmaceuticals, Inc. | 28fd7158-a617-436a-8f5c-71ffbaafe527 | 2025-10-20 | Adverse reactions | 074246 ANDA074246 55289-581-30 55289-581 55289058130 |
| Cimetidine | CIMETIDINE | A-S Medication Solutions | 28fa98b3-6c78-4b7b-9a37-84c879dbf58a | 2025-05-02 | Adverse reactions | 074246 ANDA074246 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197507 | cimetidine 400 MG Oral Tablet | PSN | 28fd7158-a617-436a-8f5c-71ffbaafe527 | 13 |
| 197507 | cimetidine 400 MG Oral Tablet | SCD | 28fd7158-a617-436a-8f5c-71ffbaafe527 | 13 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 55289-581-30 | 55289058130 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-581-30) | 2015-11-02 | 0000-00-00 | No | No | Current |