Fentanyl Citrate
- Product NDC
- 0093-7866
- 11-digit product format
- 000937866
- Labeler code
- 0093
- Product ID
- 0093-7866_4dbe9184-14cd-4666-aabf-1b7fece92337
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fentanyl Citrate
- Dosage form
- LOZENGE
- Route
- ORAL; TRANSMUCOSAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- NDA020747
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2015-12-08
- Marketing end
- 2026-08-31
- Substance
- FENTANYL CITRATE
- Active strength
- 400 ug/1
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fentanyl Citrate
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FENTANYL CITRATE | 400 ug/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | MUN5LYG46H |
| Rxcui | 310293, 310294, 310295, 310297, 313992, 313993 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 726062af-1135-4707-a1d7-57256991bbf9 | Product name | 2 | 20250226 |
| 77d14d2b-b9bf-4254-8dd6-c60dedb281d3 | Product name | 1 | 20231002 |
| a8df478d-5b88-9654-981b-87dff14dda8b | Product name | 2 | 20190801 |
| e9b48db2-e05b-8c2d-e4ac-a5a2efb26b57 | Product name | 2 | 20180118 |
| bb365072-425e-ca0a-021e-fd8b78162502 | Product name | 2 | 20161228 |
| 339915c8-cc8f-ceb4-1d3f-5ea267d21ea6 | Product name | 2 | 20160104 |
| 19c71a3d-ed9c-166b-a7e5-38c250c35631 | Product name | 1 | 20140508 |
| 739fa0ac-b690-63c4-9904-e20dffbf78f9 | Product name | 1 | 20140508 |
| 7763fcbb-367d-ed06-b37f-e1529b6241be | Product name | 1 | 20140508 |
| d9ff6610-5d2e-d5c8-8a19-867d4a1efb77 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0093-7866-19 | Fentanyl Citrate | 1 in 1 BLISTER PACK | LOZENGE | 1 | 16 | |
| 0093-7866-65 | Fentanyl Citrate | 30 in 1 CARTON | LOZENGE | 30 | 16 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310293 | fentaNYL citrate 1200 MCG Oral Lozenge | PSN | 78221eab-66fd-4cd8-9c81-af52eb83671c | 16 |
| 310294 | fentaNYL citrate 1600 MCG Oral Lozenge | PSN | 78221eab-66fd-4cd8-9c81-af52eb83671c | 16 |
| 310295 | fentaNYL citrate 200 MCG Oral Lozenge | PSN | 78221eab-66fd-4cd8-9c81-af52eb83671c | 16 |
| 310297 | fentaNYL citrate 400 MCG Oral Lozenge | PSN | 78221eab-66fd-4cd8-9c81-af52eb83671c | 16 |
| 313992 | fentaNYL citrate 600 MCG Oral Lozenge | PSN | 78221eab-66fd-4cd8-9c81-af52eb83671c | 16 |
| 313993 | fentaNYL citrate 800 MCG Oral Lozenge | PSN | 78221eab-66fd-4cd8-9c81-af52eb83671c | 16 |
| 310295 | fentanyl 0.2 MG Oral Lozenge | SCD | 78221eab-66fd-4cd8-9c81-af52eb83671c | 16 |
| 310297 | fentanyl 0.4 MG Oral Lozenge | SCD | 78221eab-66fd-4cd8-9c81-af52eb83671c | 16 |
| 313992 | fentanyl 0.6 MG Oral Lozenge | SCD | 78221eab-66fd-4cd8-9c81-af52eb83671c | 16 |
| 313993 | fentanyl 0.8 MG Oral Lozenge | SCD | 78221eab-66fd-4cd8-9c81-af52eb83671c | 16 |
| 310293 | fentanyl 1.2 MG Oral Lozenge | SCD | 78221eab-66fd-4cd8-9c81-af52eb83671c | 16 |
| 310294 | fentanyl 1.6 MG Oral Lozenge | SCD | 78221eab-66fd-4cd8-9c81-af52eb83671c | 16 |
| 310293 | fentanyl (as fentanyl citrate) 1200 MCG Oral Lozenge | SY | 78221eab-66fd-4cd8-9c81-af52eb83671c | 16 |
| 310294 | fentanyl (as fentanyl citrate) 1600 MCG Oral Lozenge | SY | 78221eab-66fd-4cd8-9c81-af52eb83671c | 16 |
| 310295 | fentanyl (as fentanyl citrate) 200 MCG Oral Lozenge | SY | 78221eab-66fd-4cd8-9c81-af52eb83671c | 16 |
| 310297 | fentanyl (as fentanyl citrate) 400 MCG Oral Lozenge | SY | 78221eab-66fd-4cd8-9c81-af52eb83671c | 16 |
| 313992 | fentanyl (as fentanyl citrate) 600 MCG Oral Lozenge | SY | 78221eab-66fd-4cd8-9c81-af52eb83671c | 16 |
| 313993 | fentanyl (as fentanyl citrate) 800 MCG Oral Lozenge | SY | 78221eab-66fd-4cd8-9c81-af52eb83671c | 16 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0093-7866-19 | 00093786619 | 1 in 1 BLISTER PACK | Historical | |||||
| 0093-7866-65 | 00093786665 | 30 BLISTER PACK in 1 CARTON (0093-7866-65) / 1 LOZENGE in 1 BLISTER PACK (0093-7866-19) | 30 blister pack | 2015-12-08 | 2026-08-31 | No | No | Current |