FDA.reportPublic FDA data

Norpace

Product NDC
0025-2762
11-digit product format
000252762
Labeler code
0025
Product ID
0025-2762_acc7751f-7484-4d53-8a6b-0194f23da1c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
disopyramide phosphate
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
NDA017447
Marketing category
NDA
Marketing start
1977-09-01
Substance
DISOPYRAMIDE PHOSPHATE
Active strength
150 mg/1
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Norpace
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DISOPYRAMIDE PHOSPHATE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN6BOM1935W
Rxcui209066, 209692, 309958, 309960, 636793, 636794, 902648, 902652

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d08b5e1c-4339-4b83-bd26-a59d84e2a782Product name120170614

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0025-2762-31Norpace100 in 1 BOTTLECAPSULE, GELATIN COATED10021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0025-2762-31EA - Each0025-27622225b7bd-1173-45e0-915f-5e570e536b5b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
disopyramide phosphateACTIVE INGREDIENTN6BOM1935WNORPACE (DISOPYRAMIDE PHOSPHATE) CAPSULE, GELATIN COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC]3
disopyramideACTIVE MOIETYGFO928U8MQNORPACE (DISOPYRAMIDE PHOSPHATE) CAPSULE, GELATIN COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC]3
ethylcelluloseINACTIVE INGREDIENT7Z8S9VYZ4BNORPACE (DISOPYRAMIDE PHOSPHATE) CAPSULE, GELATIN COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNORPACE (DISOPYRAMIDE PHOSPHATE) CAPSULE, GELATIN COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC]3
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYNORPACE (DISOPYRAMIDE PHOSPHATE) CAPSULE, GELATIN COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NORPACE (DISOPYRAMIDE PHOSPHATE) CAPSULE, GELATIN COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC]3
gelatinINACTIVE INGREDIENT2G86QN327LNORPACE (DISOPYRAMIDE PHOSPHATE) CAPSULE, GELATIN COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC]3
lactoseINACTIVE INGREDIENTJ2B2A4N98GNORPACE (DISOPYRAMIDE PHOSPHATE) CAPSULE, GELATIN COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC]3
shellacINACTIVE INGREDIENT46N107B71ONORPACE (DISOPYRAMIDE PHOSPHATE) CAPSULE, GELATIN COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC]3
starch, cornINACTIVE INGREDIENTO8232NY3SJNORPACE (DISOPYRAMIDE PHOSPHATE) CAPSULE, GELATIN COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC]3
sucroseINACTIVE INGREDIENTC151H8M554NORPACE (DISOPYRAMIDE PHOSPHATE) CAPSULE, GELATIN COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC]3
talcINACTIVE INGREDIENT7SEV7J4R1UNORPACE (DISOPYRAMIDE PHOSPHATE) CAPSULE, GELATIN COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC]3
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPNORPACE (DISOPYRAMIDE PHOSPHATE) CAPSULE, GELATIN COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0025-2762NORPACE (DISOPYRAMIDE PHOSPHATE) CAPSULE, GELATIN COATED NORPACE CR (DISOPYRAMIDE PHOSPHATE) CAPSULE, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]19Current NDC, Legacy NDC, 1 package rows20240817_e2aa1642-d262-4520-bc6a-9fd3ad795677.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636793disopyramide phosphate 100 MG 12HR Extended Release Oral CapsulePSNe2aa1642-d262-4520-bc6a-9fd3ad79567721
309958disopyramide phosphate 100 MG Oral CapsulePSNe2aa1642-d262-4520-bc6a-9fd3ad79567721
636794disopyramide phosphate 150 MG 12HR Extended Release Oral CapsulePSNe2aa1642-d262-4520-bc6a-9fd3ad79567721
309960disopyramide phosphate 150 MG Oral CapsulePSNe2aa1642-d262-4520-bc6a-9fd3ad79567721
209066Norpace 100 MG Oral CapsulePSNe2aa1642-d262-4520-bc6a-9fd3ad79567721
209692Norpace 150 MG Oral CapsulePSNe2aa1642-d262-4520-bc6a-9fd3ad79567721
902648Norpace CR 100 MG 12HR Extended Release Oral CapsulePSNe2aa1642-d262-4520-bc6a-9fd3ad79567721
902652Norpace CR 150 MG 12HR Extended Release Oral CapsulePSNe2aa1642-d262-4520-bc6a-9fd3ad79567721
90264812 HR disopyramide 100 MG Extended Release Oral Capsule [Norpace]SBDe2aa1642-d262-4520-bc6a-9fd3ad79567721
90265212 HR disopyramide 150 MG Extended Release Oral Capsule [Norpace]SBDe2aa1642-d262-4520-bc6a-9fd3ad79567721
209066disopyramide 100 MG Oral Capsule [Norpace]SBDe2aa1642-d262-4520-bc6a-9fd3ad79567721
209692disopyramide 150 MG Oral Capsule [Norpace]SBDe2aa1642-d262-4520-bc6a-9fd3ad79567721
63679312 HR disopyramide 100 MG Extended Release Oral CapsuleSCDe2aa1642-d262-4520-bc6a-9fd3ad79567721
63679412 HR disopyramide 150 MG Extended Release Oral CapsuleSCDe2aa1642-d262-4520-bc6a-9fd3ad79567721
309958disopyramide 100 MG Oral CapsuleSCDe2aa1642-d262-4520-bc6a-9fd3ad79567721
309960disopyramide 150 MG Oral CapsuleSCDe2aa1642-d262-4520-bc6a-9fd3ad79567721
90264812 HR Norpace 100 MG Extended Release Oral CapsuleSYe2aa1642-d262-4520-bc6a-9fd3ad79567721
90265212 HR Norpace 150 MG Extended Release Oral CapsuleSYe2aa1642-d262-4520-bc6a-9fd3ad79567721
309958disopyramide 100 MG (as disopyramide phosphate) Oral CapsuleSYe2aa1642-d262-4520-bc6a-9fd3ad79567721
636793disopyramide 100 MG 12 HR Extended Release Oral CapsuleSYe2aa1642-d262-4520-bc6a-9fd3ad79567721
309960disopyramide 150 MG (as disopyramide phosphate) Oral CapsuleSYe2aa1642-d262-4520-bc6a-9fd3ad79567721
636794disopyramide 150 MG 12 HR Extended Release Oral CapsuleSYe2aa1642-d262-4520-bc6a-9fd3ad79567721
209066Norpace (as disopyramide phosphate) 100 MG Oral CapsuleSYe2aa1642-d262-4520-bc6a-9fd3ad79567721
209692Norpace (as disopyramide phosphate) 150 MG Oral CapsuleSYe2aa1642-d262-4520-bc6a-9fd3ad79567721
209066Norpace 100 MG Oral CapsuleSYe2aa1642-d262-4520-bc6a-9fd3ad79567721
209692Norpace 150 MG Oral CapsuleSYe2aa1642-d262-4520-bc6a-9fd3ad79567721
902648Norpace CR (as disopyramide phosphate) 100 MG 12 HR Extended Release Oral CapsuleSYe2aa1642-d262-4520-bc6a-9fd3ad79567721
902652Norpace CR (as disopyramide phosphate) 150 MG 12 HR Extended Release Oral CapsuleSYe2aa1642-d262-4520-bc6a-9fd3ad79567721

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0025-2762-3100025276231100 CAPSULE, GELATIN COATED in 1 BOTTLE (0025-2762-31) 1977-09-010000-00-00NoNoCurrent