FDA.reportPublic FDA data

Naratriptan

Product NDC
69452-341
11-digit product format
694520341
Labeler code
69452
Product ID
69452-341_4dcbf4e0-a9ed-44d9-b610-024173094971
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naratriptan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA091441
Marketing category
ANDA
Marketing start
2022-04-11
Substance
NARATRIPTAN HYDROCHLORIDE
Active strength
2.5 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
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Naratriptan
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NARATRIPTAN HYDROCHLORIDE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii10X8X4P12Z
Rxcui311918, 314135

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4672872e-6e11-64c5-0823-02c8882da049Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69452-341-60Naratriptan9 in 1 BLISTER PACKTABLET, FILM COATED93
69452-341-72Naratriptan1 in 1 CARTONTABLET, FILM COATED13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69452-341-60EA - Each69452-341bde575cc-6588-4edb-824a-97d4c31bbbca12025-05-14
69452-341-72EA - Each69452-34158c4ced4-2bc7-47fd-a253-3dd01437e3ff12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-341NARATRIPTAN TABLET, FILM COATED [BIONPHARMA INC.]3Current NDC, Legacy NDC, 2 package rows20231219_93b7e6c2-e6a7-4f6b-9ecd-62d6bb0a6dda.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311918naratriptan 1 MG Oral TabletPSN93b7e6c2-e6a7-4f6b-9ecd-62d6bb0a6dda3
314135naratriptan 2.5 MG Oral TabletPSN93b7e6c2-e6a7-4f6b-9ecd-62d6bb0a6dda3
311918naratriptan 1 MG Oral TabletSCD93b7e6c2-e6a7-4f6b-9ecd-62d6bb0a6dda3
314135naratriptan 2.5 MG Oral TabletSCD93b7e6c2-e6a7-4f6b-9ecd-62d6bb0a6dda3
311918naratriptan (as naratriptan hydrochloride) 1 MG Oral TabletSY93b7e6c2-e6a7-4f6b-9ecd-62d6bb0a6dda3
314135naratriptan (as naratriptan hydrochloride) 2.5 MG Oral TabletSY93b7e6c2-e6a7-4f6b-9ecd-62d6bb0a6dda3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69452-341-60694520341609 in 1 BLISTER PACKHistorical
69452-341-72694520341721 BLISTER PACK in 1 CARTON (69452-341-72) / 9 TABLET, FILM COATED in 1 BLISTER PACK (69452-341-60) 1 blister pack2022-04-110000-00-00NoNoCurrent