LAZANDA
- Product NDC
- 71500-140
- 11-digit product format
- 715000140
- Labeler code
- 71500
- Product ID
- 71500-140_be24d79a-2287-2b3a-e053-2a95a90a8243
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fentanyl
- Dosage form
- SPRAY
- Route
- NASAL
- Labeler
- West Therapeutic Development LLC
- Application
- NDA022569
- Marketing category
- NDA
- Marketing start
- 2018-08-25
- Marketing end
- 0000-00-00
- Substance
- FENTANYL CITRATE
- Active strength
- 400 ug/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CII
- 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 |
|---|---|---|---|
| 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 |
| 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 71500-140-01 | 2023-01-30 | C162847 | 48780-1 | f386c649-fcb9-0266-e053-dadaa90a7c1a | Lazanda (fentanyl citrate) Nasal Spray, 100 mcg, 300 mcg, 400 mcg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71500-140-01 | LAZANDA | 8 in 1 BOTTLE, SPRAY | SPRAY | 8 | 4 | |
| 71500-140-01 | LAZANDA | 1 in 1 CARTON | SPRAY | 1 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71500-140-01 | EA - Each | 71500-140 | f777fb05-52e7-4a45-82e7-cc7320542322 | 1 | 2020-02-13 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1115573 | fentaNYL 100 MCG/ACTUAT Metered Dose Nasal Spray | PSN | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
| 1729320 | fentaNYL 300 MCG/ACTUAT Metered Dose Nasal Spray | PSN | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
| 1115577 | fentaNYL 400 MCG/ACTUAT Metered Dose Nasal Spray | PSN | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
| 1115575 | Lazanda 100 MCG/ACTUAT Metered Dose Nasal Spray | PSN | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
| 1729322 | Lazanda 300 MCG/ACTUAT Metered Dose Nasal Spray | PSN | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
| 1115579 | Lazanda 400 MCG/ACTUAT Metered Dose Nasal Spray | PSN | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
| 1115575 | fentanyl 0.1 MG/ACTUAT Metered Dose Nasal Spray [Lazanda] | SBD | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
| 1729322 | fentanyl 0.3 MG/ACTUAT Metered Dose Nasal Spray [Lazanda] | SBD | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
| 1115579 | fentanyl 0.4 MG/ACTUAT Metered Dose Nasal Spray [Lazanda] | SBD | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
| 1115573 | fentanyl 0.1 MG/ACTUAT Metered Dose Nasal Spray | SCD | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
| 1729320 | fentanyl 0.3 MG/ACTUAT Metered Dose Nasal Spray | SCD | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
| 1115577 | fentanyl 0.4 MG/ACTUAT Metered Dose Nasal Spray | SCD | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
| 1115573 | fentanyl (as fentanyl citrate) 100 MCG/ACTUAT Metered Dose Nasal Spray | SY | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
| 1115577 | fentanyl (as fentanyl citrate) 400 MCG/ACTUAT Metered Dose Nasal Spray | SY | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
| 1729320 | fentanyl 300 MCG/ACTUAT Metered Dose Nasal Spray | SY | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
| 1115575 | Lazanda 0.1 MG/ACTUAT Metered Dose Nasal Spray | SY | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
| 1729322 | Lazanda 0.3 MG/ACTUAT Metered Dose Nasal Spray | SY | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
| 1115579 | Lazanda 0.4 MG/ACTUAT Metered Dose Nasal Spray | SY | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
| 1115575 | Lazanda 100 MCG/ACTUAT Metered Dose Nasal Spray | SY | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
| 1729322 | Lazanda 300 MCG/ACTUAT Metered Dose Nasal Spray | SY | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
| 1115579 | Lazanda 400 MCG/ACTUAT Metered Dose Nasal Spray | SY | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 71500-140-01 | 71500014001 | 1 BOTTLE, SPRAY in 1 CARTON (71500-140-01) > 8 SPRAY in 1 BOTTLE, SPRAY | 2018-08-25 | 0000-00-00 | No | No | Current |