Irbesartan
- Product NDC
- 0955-1042
- 11-digit product format
- 009551042
- Labeler code
- 0955
- Product ID
- 0955-1042_5236a5fb-5969-4cc2-bcd1-400e261fbf46
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- irbesartan
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Winthrop U.S.
- Application
- NDA020757
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2019-09-30
- Marketing end
- 0000-00-00
- Substance
- IRBESARTAN
- Active strength
- 300 mg/1
- Pharmacologic classes
- Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 34942a29-de4f-d63c-7755-ba18fe1411a0 | Product name | 6 | 20180619 |
| a7349398-661d-d9fc-46df-7e128bbd61d9 | Product name | 5 | 20171113 |
| e0eeb018-194e-4b70-a57d-bac47a97b8ea | Product name | 1 | 20160825 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0955-1042-90 | 2024-12-06 | C162847 | 48780-1 | 1030e365-45d3-111a-e063-dadaa90a10e2 | 8c5a4a2a-234e-4702-9ba0-844ea86ec8b9 |
| 0955-1042-90 | 2024-07-30 | C162847 | 48780-1 | 1030e365-45d3-111a-e063-dadaa90a10e2 | 8c5a4a2a-234e-4702-9ba0-844ea86ec8b9 |
| 0955-1042-90 | 2024-01-30 | C162847 | 48780-1 | 1030e365-45d3-111a-e063-dadaa90a10e2 | 8c5a4a2a-234e-4702-9ba0-844ea86ec8b9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0955-1042-30 | EA - Each | 0955-1042 | c26b5778-fa87-4829-b861-f4df93d0ea76 | 1 | 2012-07-24 |
| 0955-1042-90 | EA - Each | 0955-1042 | fad81a20-2384-4558-85e9-2ead6a20952c | 1 | 2012-07-24 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 200096 | irbesartan 300 MG Oral Tablet | PSN | 07a6a82f-6a28-4784-8fbc-6f356ecdcdd1 | 6 |
| 200096 | irbesartan 300 MG Oral Tablet | SCD | 07a6a82f-6a28-4784-8fbc-6f356ecdcdd1 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0955-1042-90 | 00955104290 | 90 TABLET, FILM COATED in 1 BOTTLE (0955-1042-90) | 2019-09-30 | 0000-00-00 | No | No | Current |