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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct0310-6627IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage0310-66270310-6627-02IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021332-001SYMLINPRAMLINTIDE ACETATEEQ 3MG BASE/5ML (EQ 600MCG BASE/ML)INJECTABLE / SUBCUTANEOUS2005-03-16
N021332-002SYMLINPRAMLINTIDE ACETATEEQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)INJECTABLE / SUBCUTANEOUSRLD2007-09-25
N021332-003SYMLINPRAMLINTIDE ACETATEEQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)INJECTABLE / SUBCUTANEOUSRLD2007-09-25

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N021332-001SYMLINEQ 3MG BASE/5ML (EQ 600MCG BASE/ML)INJECTABLE / SUBCUTANEOUS2005-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07N021332-002SYMLINEQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)INJECTABLE / SUBCUTANEOUSRLD2007-09-25caaa826d4ba7…
2026-08-18 06:07:402026-07N021332-003SYMLINEQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)INJECTABLE / SUBCUTANEOUSRLD2007-09-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021332-001SYMLINEQ 3MG BASE/5ML (EQ 600MCG BASE/ML)INJECTABLE / SUBCUTANEOUS2005-03-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021332-002SYMLINEQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)INJECTABLE / SUBCUTANEOUSRLD2007-09-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021332-003SYMLINEQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)INJECTABLE / SUBCUTANEOUSRLD2007-09-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021332-001SYMLINEQ 3MG BASE/5ML (EQ 600MCG BASE/ML)INJECTABLE / SUBCUTANEOUS2005-03-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021332-002SYMLINEQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)INJECTABLE / SUBCUTANEOUSRLD2007-09-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021332-003SYMLINEQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)INJECTABLE / SUBCUTANEOUSRLD2007-09-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N021332-001SYMLINEQ 3MG BASE/5ML (EQ 600MCG BASE/ML)INJECTABLE / SUBCUTANEOUS2005-03-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021332-002SYMLINEQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)INJECTABLE / SUBCUTANEOUSRLD2007-09-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021332-003SYMLINEQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)INJECTABLE / SUBCUTANEOUSRLD, RS2007-09-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021332-001SYMLINEQ 3MG BASE/5ML (EQ 600MCG BASE/ML)INJECTABLE / SUBCUTANEOUS2005-03-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021332-002SYMLINEQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)INJECTABLE / SUBCUTANEOUSRLD2007-09-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021332-003SYMLINEQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)INJECTABLE / SUBCUTANEOUSRLD, RS2007-09-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021332-001SYMLINEQ 3MG BASE/5ML (EQ 600MCG BASE/ML)INJECTABLE / SUBCUTANEOUS2005-03-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021332-002SYMLINEQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)INJECTABLE / SUBCUTANEOUSRLD2007-09-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021332-003SYMLINEQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)INJECTABLE / SUBCUTANEOUSRLD, RS2007-09-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021332-001SYMLINEQ 3MG BASE/5ML (EQ 600MCG BASE/ML)INJECTABLE / SUBCUTANEOUS2005-03-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021332-002SYMLINEQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)INJECTABLE / SUBCUTANEOUSRLD2007-09-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021332-003SYMLINEQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)INJECTABLE / SUBCUTANEOUSRLD, RS2007-09-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021332-001SYMLINEQ 3MG BASE/5ML (EQ 600MCG BASE/ML)INJECTABLE / SUBCUTANEOUS2005-03-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021332-002SYMLINEQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)INJECTABLE / SUBCUTANEOUSRLD2007-09-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021332-003SYMLINEQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)INJECTABLE / SUBCUTANEOUSRLD, RS2007-09-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021332-001SYMLINEQ 3MG BASE/5ML (EQ 600MCG BASE/ML)INJECTABLE / SUBCUTANEOUS2005-03-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021332-002SYMLINEQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)INJECTABLE / SUBCUTANEOUSRLD2007-09-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021332-003SYMLINEQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)INJECTABLE / SUBCUTANEOUSRLD, RS2007-09-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021332-001SYMLINEQ 3MG BASE/5ML (EQ 600MCG BASE/ML)INJECTABLE / SUBCUTANEOUS2005-03-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021332-002SYMLINEQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)INJECTABLE / SUBCUTANEOUSRLD2007-09-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021332-003SYMLINEQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)INJECTABLE / SUBCUTANEOUSRLD, RS2007-09-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021332-001SYMLINEQ 3MG BASE/5ML (EQ 600MCG BASE/ML)INJECTABLE / SUBCUTANEOUS2005-03-16d06236e962d9…
2024-10-29 15:01 UTC2024-10N021332-002SYMLINEQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)INJECTABLE / SUBCUTANEOUSRLD2007-09-25d06236e962d9…
2024-10-29 15:01 UTC2024-10N021332-003SYMLINEQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)INJECTABLE / SUBCUTANEOUSRLD, RS2007-09-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021332-001SYMLINEQ 3MG BASE/5ML (EQ 600MCG BASE/ML)INJECTABLE / SUBCUTANEOUS2005-03-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021332-002SYMLINEQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)INJECTABLE / SUBCUTANEOUSRLD2007-09-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021332-003SYMLINEQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)INJECTABLE / SUBCUTANEOUSRLD, RS2007-09-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021332-001SYMLINEQ 3MG BASE/5ML (EQ 600MCG BASE/ML)INJECTABLE / SUBCUTANEOUS2005-03-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021332-002SYMLINEQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)INJECTABLE / SUBCUTANEOUSRLD2007-09-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021332-003SYMLINEQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)INJECTABLE / SUBCUTANEOUSRLD, RS2007-09-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021332-001SYMLINEQ 3MG BASE/5ML (EQ 600MCG BASE/ML)INJECTABLE / SUBCUTANEOUS2005-03-161e350fbaab3a…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021332-00156864112019-03-16U-638Drug substance, Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021332-00256864112019-03-16U-638Drug substance, Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021332-00356864112019-03-16U-638Drug substance, Drug product74a2ff9319b5…
2019-12-14 00:12 UTC2019-12N021332-00156864112019-03-16U-638Drug substance, Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021332-00256864112019-03-16U-638Drug substance, Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021332-00356864112019-03-16U-638Drug substance, Drug product3f01610625f2…
2019-09-15 20:21 UTC2019-09N021332-00156864112019-03-16U-638Drug substance, Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021332-00256864112019-03-16U-638Drug substance, Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021332-00356864112019-03-16U-638Drug substance, Drug productb00525d2431f…
2019-07-19 19:46 UTC2019-07N021332-00156864112019-03-16U-638Drug substance, Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021332-00256864112019-03-16U-638Drug substance, Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021332-00356864112019-03-16U-638Drug substance, Drug productea99ee380514…

Additional Listing Data#

Finished product
Yes
Brand name base
SymlinPen

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMLINTIDE ACETATE1000 ug/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
726I6TE06GInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
861042Internal RxNorm lookup
861043Internal RxNorm lookup
861044Internal RxNorm lookup
861045Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4aea30ff-eb0d-45c1-b114-3127966328ffAvailable on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SymlinPenPRAMLINTIDE ACETATEAstraZeneca Pharmaceuticals LP4aea30ff-eb0d-45c1-b114-3127966328ff2019-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021332
application number: NDA021332
ndc (product): 0310-6627

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