FDA.reportPublic FDA data

PAMELOR

Product NDC
0406-9910
11-digit product format
004069910
Labeler code
0406
Product ID
0406-9910_0c3b20b3-e852-4959-815a-90ed989a30e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nortriptyline hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
SpecGx LLC
Application
NDA018013
Marketing category
NDA
Marketing start
1977-08-01
Marketing end
2027-11-30
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PAMELOR

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NORTRIPTYLINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii00FN6IH15D
Rxcui198045, 198046, 198047, 209329, 209339, 209350, 209391, 317136

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
de76de11-1019-6138-2d8a-16fa566ae22aProduct name220241009
53e88688-54e1-9681-22b8-e499bd715088Product name220210729

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0406-9910-03PAMELOR30 in 1 BOTTLECAPSULE3024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0406-9910-03EA - Each0406-991035c17e73-a9a8-402a-971d-1b36429eb45912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NORTRIPTYLINE HYDROCHLORIDEACTIVE INGREDIENT00FN6IH15DPAMELOR (NORTRIPTYLINE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]14
NORTRIPTYLINEACTIVE MOIETYBL03SY4LXBPAMELOR (NORTRIPTYLINE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]14
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPAMELOR (NORTRIPTYLINE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]14
DIMETHICONE 350INACTIVE INGREDIENT2Y53S6ATLUPAMELOR (NORTRIPTYLINE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]14
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PAMELOR (NORTRIPTYLINE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]14
GELATININACTIVE INGREDIENT2G86QN327LPAMELOR (NORTRIPTYLINE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]14
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPAMELOR (NORTRIPTYLINE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]14
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAMELOR (NORTRIPTYLINE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0406-9910PAMELOR (NORTRIPTYLINE HYDROCHLORIDE) CAPSULE [SPECGX LLC]23Current NDC, Legacy NDC, 1 package rows20241208_e17dc299-f52d-414d-ab6e-e809bd6f8acb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198045nortriptyline HCl 10 MG Oral CapsulePSNe17dc299-f52d-414d-ab6e-e809bd6f8acb24
317136nortriptyline HCl 25 MG Oral CapsulePSNe17dc299-f52d-414d-ab6e-e809bd6f8acb24
198046nortriptyline HCl 50 MG Oral CapsulePSNe17dc299-f52d-414d-ab6e-e809bd6f8acb24
198047nortriptyline HCl 75 MG Oral CapsulePSNe17dc299-f52d-414d-ab6e-e809bd6f8acb24
209329Pamelor 10 MG Oral CapsulePSNe17dc299-f52d-414d-ab6e-e809bd6f8acb24
209339Pamelor 25 MG Oral CapsulePSNe17dc299-f52d-414d-ab6e-e809bd6f8acb24
209350Pamelor 50 MG Oral CapsulePSNe17dc299-f52d-414d-ab6e-e809bd6f8acb24
209391Pamelor 75 MG Oral CapsulePSNe17dc299-f52d-414d-ab6e-e809bd6f8acb24
209329nortriptyline 10 MG Oral Capsule [Pamelor]SBDe17dc299-f52d-414d-ab6e-e809bd6f8acb24
209339nortriptyline 25 MG Oral Capsule [Pamelor]SBDe17dc299-f52d-414d-ab6e-e809bd6f8acb24
209350nortriptyline 50 MG Oral Capsule [Pamelor]SBDe17dc299-f52d-414d-ab6e-e809bd6f8acb24
209391nortriptyline 75 MG Oral Capsule [Pamelor]SBDe17dc299-f52d-414d-ab6e-e809bd6f8acb24
198045nortriptyline 10 MG Oral CapsuleSCDe17dc299-f52d-414d-ab6e-e809bd6f8acb24
317136nortriptyline 25 MG Oral CapsuleSCDe17dc299-f52d-414d-ab6e-e809bd6f8acb24
198046nortriptyline 50 MG Oral CapsuleSCDe17dc299-f52d-414d-ab6e-e809bd6f8acb24
198047nortriptyline 75 MG Oral CapsuleSCDe17dc299-f52d-414d-ab6e-e809bd6f8acb24
198045nortriptyline (as nortriptyline HCl) 10 MG Oral CapsuleSYe17dc299-f52d-414d-ab6e-e809bd6f8acb24
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSYe17dc299-f52d-414d-ab6e-e809bd6f8acb24
198046nortriptyline (as nortriptyline HCl) 50 MG Oral CapsuleSYe17dc299-f52d-414d-ab6e-e809bd6f8acb24
198047nortriptyline (as nortriptyline HCl) 75 MG Oral CapsuleSYe17dc299-f52d-414d-ab6e-e809bd6f8acb24
209329Pamelor (nortriptyline hydrochloride) 10 MG Oral CapsuleSYe17dc299-f52d-414d-ab6e-e809bd6f8acb24
209339Pamelor (nortriptyline hydrochloride) 25 MG Oral CapsuleSYe17dc299-f52d-414d-ab6e-e809bd6f8acb24
209350Pamelor (nortriptyline hydrochloride) 50 MG Oral CapsuleSYe17dc299-f52d-414d-ab6e-e809bd6f8acb24
209391Pamelor (nortriptyline hydrochloride) 75 MG Oral CapsuleSYe17dc299-f52d-414d-ab6e-e809bd6f8acb24
209329Pamelor 10 MG Oral CapsuleSYe17dc299-f52d-414d-ab6e-e809bd6f8acb24
209339Pamelor 25 MG Oral CapsuleSYe17dc299-f52d-414d-ab6e-e809bd6f8acb24
209350Pamelor 50 MG Oral CapsuleSYe17dc299-f52d-414d-ab6e-e809bd6f8acb24
209391Pamelor 75 MG Oral CapsuleSYe17dc299-f52d-414d-ab6e-e809bd6f8acb24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0406-9910-030040699100330 CAPSULE in 1 BOTTLE (0406-9910-03) 30 capsule1977-08-012027-11-30NoNoCurrent