Fenoprofen Calcium
- Product NDC
- 42195-100
- 11-digit product format
- 421950100
- Labeler code
- 42195
- Product ID
- 42195-100_f0305a11-4494-e237-e053-2995a90ad12e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fenoprofen calcium
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Xspire Pharma
- Application
- NDA017604
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2016-05-19
- Marketing end
- 0000-00-00
- Substance
- FENOPROFEN CALCIUM
- Active strength
- 400 mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0916fe0d-58e1-5e07-2471-9a804a1b0628 | Product name | 3 | 20240514 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| 090af53b-bc54-1ac8-5eee-2f06b5d9cff9 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 42195-100-60 | 2025-04-21 | C162847 | 48780-1 | ba0f9c33-4b9b-a910-e053-dadaa90a0b85 | ef59e72f-6218-4f42-8f00-d10a6a14223a |
| 42195-100-90 | 2025-04-21 | C162847 | 48780-1 | ba0f9c33-4b9b-a910-e053-dadaa90a0b85 | ef59e72f-6218-4f42-8f00-d10a6a14223a |
| 42195-100-60 | 2024-01-30 | C162847 | 48780-1 | ba0f9c33-4b9b-a910-e053-dadaa90a0b85 | ef59e72f-6218-4f42-8f00-d10a6a14223a |
| 42195-100-90 | 2024-01-30 | C162847 | 48780-1 | ba0f9c33-4b9b-a910-e053-dadaa90a0b85 | ef59e72f-6218-4f42-8f00-d10a6a14223a |
| 42195-100-90 | 2021-02-02 | C162847 | 48780-1 | ba0f9c33-4b9b-a910-e053-dadaa90a0b85 | ef59e72f-6218-4f42-8f00-d10a6a14223a |
| 42195-100-90 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-4b9b-a910-e053-dadaa90a0b85 | ef59e72f-6218-4f42-8f00-d10a6a14223a |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42195-100-90 | EA - Each | 42195-100 | 005c2065-6a9b-4307-a4f9-b419a162d7fd | 1 | 2015-10-02 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 858116 | fenoprofen calcium 400 MG Oral Capsule | PSN | 1a6aeca8-82c9-4bf7-99ad-6d065032762b | 4 |
| 858116 | fenoprofen 400 MG Oral Capsule | SCD | 1a6aeca8-82c9-4bf7-99ad-6d065032762b | 4 |
| 858116 | fenoprofen (as fenoprofen calcium) 400 MG Oral Capsule | SY | 1a6aeca8-82c9-4bf7-99ad-6d065032762b | 4 |
| 858116 | fenoprofen calcium 400 MG Oral Capsule | PSN | 7bf7114a-b053-46cc-9e00-dc3cc87b50a9 | 1 |
| 858116 | fenoprofen 400 MG Oral Capsule | SCD | 7bf7114a-b053-46cc-9e00-dc3cc87b50a9 | 1 |
| 858116 | fenoprofen (as fenoprofen calcium) 400 MG Oral Capsule | SY | 7bf7114a-b053-46cc-9e00-dc3cc87b50a9 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 42195-100-60 | 42195010060 | 60 CAPSULE in 1 BOTTLE (42195-100-60) | 60 capsule | 2019-03-25 | 0000-00-00 | No | No | Current |
| 42195-100-90 | 42195010090 | 90 CAPSULE in 1 BOTTLE (42195-100-90) | 90 capsule | 2016-05-19 | 0000-00-00 | No | No | Current |