ZOMIG
- Product NDC
- 21695-955
- 11-digit product format
- 216950955
- Labeler code
- 21695
- Product ID
- 21695-955_f2073122-5138-41ba-b791-a9b088bb98b7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zolmitriptan
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- Rebel Distributors Corp
- Application
- NDA021450
- Marketing category
- NDA
- Marketing start
- 2010-06-08
- Marketing end
- 0000-00-00
- Substance
- ZOLMITRIPTAN
- Active strength
- 5 mg/1
- Pharmacologic classes
- Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor 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 |
|---|---|---|---|
| a0fbe307-6e31-a71d-5232-3216747b9b34 | Product name | 2 | 20220316 |
| 49286735-675f-7ca8-3815-48cfc7bb5a5a | Product name | 9 | 20180828 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-955-06 | 2019-09-24 | C162847 | 48780-1 | 934fe258-48fc-48b1-e053-8cdaa90a720a | These highlights do not include all the information needed to use ZOMIG NASAL SPRAY. See full prescribing information for ZOMIG ® (zolmitriptan) NASAL SPRAY INITIAL U.S. APPROVAL: 1997 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-955-06 | ZOMIG | 1 in 1 BOTTLE, SPRAY | SPRAY, METERED | 1 | 1 | |
| 21695-955-06 | ZOMIG | 6 in 1 CARTON | SPRAY, METERED | 6 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-955-06 | EA - Each | 21695-955 | 70df7738-110b-4fb0-ba90-c2f5d44413ac | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ZOLMITRIPTAN | ACTIVE INGREDIENT | 2FS66TH3YW | ZOMIG (ZOLMITRIPTAN) SPRAY, METERED [REBEL DISTRIBUTORS CORP] | 1 | |
| ZOLMITRIPTAN | ACTIVE MOIETY | 2FS66TH3YW | ZOMIG (ZOLMITRIPTAN) SPRAY, METERED [REBEL DISTRIBUTORS CORP] | 1 | |
| CITRIC ACID ANHYDROUS | INACTIVE INGREDIENT | XF417D3PSL | ZOMIG (ZOLMITRIPTAN) SPRAY, METERED [REBEL DISTRIBUTORS CORP] | 1 | |
| NITROGEN | INACTIVE INGREDIENT | N762921K75 | ZOMIG (ZOLMITRIPTAN) SPRAY, METERED [REBEL DISTRIBUTORS CORP] | 1 | |
| SODIUM PHOSPHATE, DIBASIC | INACTIVE INGREDIENT | GR686LBA74 | ZOMIG (ZOLMITRIPTAN) SPRAY, METERED [REBEL DISTRIBUTORS CORP] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | ZOMIG (ZOLMITRIPTAN) SPRAY, METERED [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 402000 | ZOLMitriptan 5 MG/ACTUAT Nasal Spray | PSN | f2073122-5138-41ba-b791-a9b088bb98b7 | 1 |
| 402169 | Zomig 5 MG/ACTUAT Nasal Spray | PSN | f2073122-5138-41ba-b791-a9b088bb98b7 | 1 |
| 402169 | zolmitriptan 5 MG/ACTUAT Nasal Spray [Zomig] | SBD | f2073122-5138-41ba-b791-a9b088bb98b7 | 1 |
| 402000 | zolmitriptan 5 MG/ACTUAT Nasal Spray | SCD | f2073122-5138-41ba-b791-a9b088bb98b7 | 1 |
| 402000 | zolmitriptan 5 MG/0.1 ML Nasal Spray | SY | f2073122-5138-41ba-b791-a9b088bb98b7 | 1 |
| 402169 | Zomig 5 MG/0.1 ML Nasal Spray | SY | f2073122-5138-41ba-b791-a9b088bb98b7 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-955-06 | 21695095506 | 1 in 1 BOTTLE, SPRAY | Historical |