SEREVENT
- Product NDC
- 68258-8961
- 11-digit product format
- 682588961
- Labeler code
- 68258
- Product ID
- 68258-8961_198f20a2-218e-4a0f-a4c1-ae7c3b62e1c6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- salmeterol xinafoate
- Dosage form
- POWDER, METERED
- Route
- ORAL; RESPIRATORY (INHALATION)
- Labeler
- Dispensing Solutions, Inc.
- Application
- NDA020692
- Marketing category
- NDA
- Marketing start
- 1997-11-25
- Marketing end
- 0000-00-00
- Substance
- SALMETEROL XINAFOATE
- Active strength
- 50 ug/1
- Pharmacologic classes
- Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a31ad3df-8021-2ea1-94eb-0fe2f49b7729 | Product name | 4 | 20220719 |
| 0e5a25a6-9f05-44b5-8449-aa63e59f7202 | Product name | 1 | 20170426 |
| 811691fa-281f-6d95-fb49-e2337fb2e146 | Product name | 1 | 20140508 |
| aef26912-037b-9a4e-db49-225ef6dfd8f1 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68258-8961-6 | 2019-11-13 | C162847 | 48780-1 | 97449f38-d15d-f6ea-e053-dbdaa90aa703 | These highlights do not include all the information needed to use SEREVENT DISKUS safely and effectively. See full prescribing information for SEREVENT DISKUS. SEREVENT DISKUS (salmeterol xinafoate inhalation powder) FOR ORAL INHALATION Initial U.S. Approval: 1994 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68258-8961-6 | SEREVENTDISKUS | 60 in 1 INHALER | POWDER, METERED | 60 | 2 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| SALMETEROL XINAFOATE | ACTIVE INGREDIENT | 6EW8Q962A5 | SEREVENT DISKUS (SALMETEROL XINAFOATE) POWDER, METERED [DISPENSING SOLUTIONS, INC.] | 2 | |
| SALMETEROL | ACTIVE MOIETY | 2I4BC502BT | SEREVENT DISKUS (SALMETEROL XINAFOATE) POWDER, METERED [DISPENSING SOLUTIONS, INC.] | 2 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | SEREVENT DISKUS (SALMETEROL XINAFOATE) POWDER, METERED [DISPENSING SOLUTIONS, INC.] | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68258-8961 | SEREVENT DISKUS (SALMETEROL XINAFOATE) POWDER, METERED [DISPENSING SOLUTIONS, INC.] | 2 | Legacy NDC, 1 package rows | 20120928_c4925b2c-bde1-45fd-8109-dc75bee3b7a3.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 866048 | salmeterol 50 MCG/INHAL Dry Powder Inhaler, 60 Bisters | PSN | c4925b2c-bde1-45fd-8109-dc75bee3b7a3 | 2 |
| 866049 | Serevent Diskus 50 MCG/INHAL Dry Powder Inhaler, 60 Blisters | PSN | c4925b2c-bde1-45fd-8109-dc75bee3b7a3 | 2 |
| 866049 | 60 ACTUAT salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler [Serevent] | SBD | c4925b2c-bde1-45fd-8109-dc75bee3b7a3 | 2 |
| 866048 | 60 ACTUAT salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler | SCD | c4925b2c-bde1-45fd-8109-dc75bee3b7a3 | 2 |
| 866049 | 60 ACTUAT Serevent 0.05 MG/ACTUAT Dry Powder Inhaler | SY | c4925b2c-bde1-45fd-8109-dc75bee3b7a3 | 2 |
| 866048 | salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 Actuat | SY | c4925b2c-bde1-45fd-8109-dc75bee3b7a3 | 2 |
| 866049 | Serevent Diskus 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUAT | SY | c4925b2c-bde1-45fd-8109-dc75bee3b7a3 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 68258-8961-6 | 68258896106 | 60 in 1 INHALER | Historical |