FDA.reportPublic FDA data

SymlinPen

Product NDC
0310-6627
11-digit product format
003106627
Labeler code
0310
Product ID
0310-6627_a84753f1-6ac5-4a47-a382-29972938ccaa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pramlintide acetate
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
AstraZeneca Pharmaceuticals LP
Application
NDA021332
Marketing category
NDA
Marketing start
2015-01-08
Marketing end
2027-01-31
Substance
PRAMLINTIDE ACETATE
Active strength
1000 ug/mL
Pharmacologic classes
Amylin Agonists [MoA], Amylin Analog [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SymlinPen

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMLINTIDE ACETATE1000 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii726I6TE06G
Rxcui861042, 861043, 861044, 861045

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0310-6627-022024-04-11C16284748780-10191ceaa-65d6-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use SYMLIN safely and effectively. See full prescribing information for SYMLIN. SYMLIN ® (pramlintide acetate) injection for subcutaneous use Initial U.S. Approval: 2005
0310-6627-022023-07-28C16284748780-10191ceaa-65d6-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use SYMLIN safely and effectively. See full prescribing information for SYMLIN. SYMLIN ® (pramlintide acetate) injection for subcutaneous use Initial U.S. Approval: 2005

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0310-6627-02SymlinPen2.7 mL in 1 CARTRIDGEINJECTION2.718
0310-6627-02SymlinPen2 in 1 CARTONINJECTION218

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0310-6627-02ML - Milliliter0310-6627a732ec1b-2ae0-4b80-b485-ee7cd04d423612015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
pramlintide acetateACTIVE INGREDIENT726I6TE06GSYMLINPEN (PRAMLINTIDE ACETATE) INJECTION [ASTRAZENECA PHARMACEUTICALS LP]3
pramlintideACTIVE MOIETYD3FM8FA78TSYMLINPEN (PRAMLINTIDE ACETATE) INJECTION [ASTRAZENECA PHARMACEUTICALS LP]3
acetic acidINACTIVE INGREDIENTQ40Q9N063PSYMLINPEN (PRAMLINTIDE ACETATE) INJECTION [ASTRAZENECA PHARMACEUTICALS LP]3
mannitolINACTIVE INGREDIENT3OWL53L36ASYMLINPEN (PRAMLINTIDE ACETATE) INJECTION [ASTRAZENECA PHARMACEUTICALS LP]3
metacresolINACTIVE INGREDIENTGGO4Y809LOSYMLINPEN (PRAMLINTIDE ACETATE) INJECTION [ASTRAZENECA PHARMACEUTICALS LP]3
sodium acetateINACTIVE INGREDIENT4550K0SC9BSYMLINPEN (PRAMLINTIDE ACETATE) INJECTION [ASTRAZENECA PHARMACEUTICALS LP]3
waterINACTIVE INGREDIENT059QF0KO0RSYMLINPEN (PRAMLINTIDE ACETATE) INJECTION [ASTRAZENECA PHARMACEUTICALS LP]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0310-6627SYMLINPEN (PRAMLINTIDE ACETATE) INJECTION [ASTRAZENECA PHARMACEUTICALS LP]18Current NDC, Legacy NDC, 2 package rows20240820_4aea30ff-eb0d-45c1-b114-3127966328ff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861044pramlintide acetate 1000 MCG/ML in 1.5 ML Pen InjectorPSN4aea30ff-eb0d-45c1-b114-3127966328ff18
861042pramlintide acetate 1000 MCG/ML in 2.7 ML Pen InjectorPSN4aea30ff-eb0d-45c1-b114-3127966328ff18
861043SymlinPen 120 1000 MCG/ML in 2.7 mL Pen InjectorPSN4aea30ff-eb0d-45c1-b114-3127966328ff18
861045SymlinPen 60 1000 MCG/ML in 1.5 ML Pen InjectorPSN4aea30ff-eb0d-45c1-b114-3127966328ff18
8610451.5 ML pramlintide acetate 1 MG/ML Pen Injector [Symlin]SBD4aea30ff-eb0d-45c1-b114-3127966328ff18
8610432.7 ML pramlintide acetate 1 MG/ML Pen Injector [Symlin]SBD4aea30ff-eb0d-45c1-b114-3127966328ff18
8610441.5 ML pramlintide acetate 1 MG/ML Pen InjectorSCD4aea30ff-eb0d-45c1-b114-3127966328ff18
8610422.7 ML pramlintide acetate 1 MG/ML Pen InjectorSCD4aea30ff-eb0d-45c1-b114-3127966328ff18
8610441.5 ML pramlintide acetate 1000 MCG/ML Pen InjectorSY4aea30ff-eb0d-45c1-b114-3127966328ff18
8610451.5 ML Symlin 1 MG/ML Pen InjectorSY4aea30ff-eb0d-45c1-b114-3127966328ff18
8610432.7 ML Symlin 1 MG/ML Pen InjectorSY4aea30ff-eb0d-45c1-b114-3127966328ff18
861044pramlintide acetate 1.5 MG per 1.5 ML Pen InjectorSY4aea30ff-eb0d-45c1-b114-3127966328ff18
861044pramlintide acetate 1500 MCG per 1.5 ML Pen InjectorSY4aea30ff-eb0d-45c1-b114-3127966328ff18
861042pramlintide acetate 2.7 MG per 2.7 ML Pen InjectorSY4aea30ff-eb0d-45c1-b114-3127966328ff18
861042pramlintide acetate 2700 MCG per 2.7 ML Pen InjectorSY4aea30ff-eb0d-45c1-b114-3127966328ff18
861045Symlin 1 MG/ML 1.5 ML Prefilled PenSY4aea30ff-eb0d-45c1-b114-3127966328ff18
861043Symlin 1 MG/ML 2.7 ML Prefilled PenSY4aea30ff-eb0d-45c1-b114-3127966328ff18
861043SymlinPen 120 1000 MCG per ML Pen Injector, 2.7 MLSY4aea30ff-eb0d-45c1-b114-3127966328ff18
861045SymlinPen 60 1000 MCG per ML Pen Injector, 1.5 MLSY4aea30ff-eb0d-45c1-b114-3127966328ff18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0310-6627-02003106627022 CARTRIDGE in 1 CARTON (0310-6627-02) / 2.7 mL in 1 CARTRIDGE2 cartridge2015-01-082027-01-31NoNoCurrent