Norpace CR

Product NDC
0025-2732
11-digit product format
000252732
Labeler code
0025
Product ID
0025-2732_acc7751f-7484-4d53-8a6b-0194f23da1c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
disopyramide phosphate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
NDA018655
Marketing category
NDA
Marketing start
1982-07-20
Substance
DISOPYRAMIDE PHOSPHATE
Active strength
100 mg/1
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018655-001NORPACE CRDISOPYRAMIDE PHOSPHATEEQ 100MG BASECAPSULE, EXTENDED RELEASE / ORALRLD1982-07-20
N018655-002NORPACE CRDISOPYRAMIDE PHOSPHATEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALRLD, RS1982-07-20

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N018655-001NORPACE CREQ 100MG BASECAPSULE, EXTENDED RELEASE / ORALRLD1982-07-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018655-002NORPACE CREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALRLD, RS1982-07-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018655-001NORPACE CREQ 100MG BASECAPSULE, EXTENDED RELEASE / ORALRLD1982-07-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018655-002NORPACE CREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALRLD, RS1982-07-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08N018655-001NORPACE CREQ 100MG BASECAPSULE, EXTENDED RELEASE / ORALRLD1982-07-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018655-002NORPACE CREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALRLD, RS1982-07-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018655-001NORPACE CREQ 100MG BASECAPSULE, EXTENDED RELEASE / ORALRLD1982-07-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018655-002NORPACE CREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALRLD, RS1982-07-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018655-001NORPACE CREQ 100MG BASECAPSULE, EXTENDED RELEASE / ORALRLD1982-07-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018655-002NORPACE CREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALRLD, RS1982-07-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018655-001NORPACE CREQ 100MG BASECAPSULE, EXTENDED RELEASE / ORALRLD1982-07-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018655-002NORPACE CREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALRLD, RS1982-07-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018655-001NORPACE CREQ 100MG BASECAPSULE, EXTENDED RELEASE / ORALRLD1982-07-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018655-002NORPACE CREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALRLD, RS1982-07-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018655-001NORPACE CREQ 100MG BASECAPSULE, EXTENDED RELEASE / ORALRLD1982-07-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018655-002NORPACE CREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALRLD, RS1982-07-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018655-001NORPACE CREQ 100MG BASECAPSULE, EXTENDED RELEASE / ORALRLD1982-07-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018655-002NORPACE CREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALRLD, RS1982-07-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018655-001NORPACE CREQ 100MG BASECAPSULE, EXTENDED RELEASE / ORALRLD1982-07-20d06236e962d9…
2024-10-29 15:01 UTC2024-10N018655-002NORPACE CREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALRLD, RS1982-07-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018655-001NORPACE CREQ 100MG BASECAPSULE, EXTENDED RELEASE / ORALRLD1982-07-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018655-002NORPACE CREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALRLD, RS1982-07-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018655-001NORPACE CREQ 100MG BASECAPSULE, EXTENDED RELEASE / ORALRLD1982-07-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018655-002NORPACE CREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALRLD, RS1982-07-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018655-001NORPACE CREQ 100MG BASECAPSULE, EXTENDED RELEASE / ORALRLD1982-07-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018655-002NORPACE CREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALRLD, RS1982-07-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018655-001NORPACE CREQ 100MG BASECAPSULE, EXTENDED RELEASE / ORALRLD1982-07-208072bd15b7f6…
2024-05-31 18:47 UTC2024-05N018655-002NORPACE CREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALRLD, RS1982-07-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018655-001NORPACE CREQ 100MG BASECAPSULE, EXTENDED RELEASE / ORALRLD1982-07-205c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018655-002NORPACE CREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALRLD, RS1982-07-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018655-001NORPACE CREQ 100MG BASECAPSULE, EXTENDED RELEASE / ORALRLD1982-07-205d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N018655-002NORPACE CREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALRLD, RS1982-07-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018655-001NORPACE CREQ 100MG BASECAPSULE, EXTENDED RELEASE / ORALRLD1982-07-204b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N018655-002NORPACE CREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALRLD, RS1982-07-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018655-001NORPACE CREQ 100MG BASECAPSULE, EXTENDED RELEASE / ORALRLD1982-07-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N018655-002NORPACE CREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALRLD, RS1982-07-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018655-001NORPACE CREQ 100MG BASECAPSULE, EXTENDED RELEASE / ORALRLD1982-07-20bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N018655-002NORPACE CREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALRLD, RS1982-07-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018655-001NORPACE CREQ 100MG BASECAPSULE, EXTENDED RELEASE / ORALRLD1982-07-20782e0a99824c…
2021-12-28 21:50 UTC2021-12N018655-002NORPACE CREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALRLD, RS1982-07-20782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DISOPYRAMIDE PHOSPHATE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
N6BOM1935WInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
209066Internal RxNorm lookup
209692Internal RxNorm lookup
309958Internal RxNorm lookup
309960Internal RxNorm lookup
636793Internal RxNorm lookup
636794Internal RxNorm lookup
902648Internal RxNorm lookup
902652Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e2aa1642-d262-4520-bc6a-9fd3ad795677Available on FDA.report

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
0025-2732-31Norpace CR100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0025-2732-31EA - Each0025-2732b308d85c-b733-44ac-b6ac-e4174ebac31d12012-07-24
0025-2732-51EA - Each0025-2732912e8e37-ef5d-4797-a474-faa4c08fd87412012-07-24

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
disopyramide phosphateACTIVE INGREDIENTN6BOM1935WNORPACE (DISOPYRAMIDE PHOSPHATE) CAPSULE, GELATIN COATED [CARILION MATERIALS MANAGEMENT]2
disopyramideACTIVE MOIETYGFO928U8MQNORPACE (DISOPYRAMIDE PHOSPHATE) CAPSULE, GELATIN COATED [CARILION MATERIALS MANAGEMENT]2
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BNORPACE (DISOPYRAMIDE PHOSPHATE) CAPSULE, GELATIN COATED [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNORPACE (DISOPYRAMIDE PHOSPHATE) CAPSULE, GELATIN COATED [CARILION MATERIALS MANAGEMENT]2
SUCROSEINACTIVE INGREDIENTC151H8M554NORPACE (DISOPYRAMIDE PHOSPHATE) CAPSULE, GELATIN COATED [CARILION MATERIALS MANAGEMENT]2
TALCINACTIVE INGREDIENT7SEV7J4R1UNORPACE (DISOPYRAMIDE PHOSPHATE) CAPSULE, GELATIN COATED [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNORPACE (DISOPYRAMIDE PHOSPHATE) CAPSULE, GELATIN COATED [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0025-2732NORPACE (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

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
Norpace CRDISOPYRAMIDE PHOSPHATEPfizer Laboratories Div Pfizer Ince2aa1642-d262-4520-bc6a-9fd3ad7956772026-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018655
application number: NDA018655
ndc (product): 0025-2732

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
309958disopyramide phosphate 100 MG Oral CapsulePSN4c02f1b8-4493-429c-b9f7-21f364e330f82
209066Norpace 100 MG Oral CapsulePSN4c02f1b8-4493-429c-b9f7-21f364e330f82
209066disopyramide 100 MG Oral Capsule [Norpace]SBD4c02f1b8-4493-429c-b9f7-21f364e330f82
309958disopyramide 100 MG Oral CapsuleSCD4c02f1b8-4493-429c-b9f7-21f364e330f82
309958disopyramide 100 MG (as disopyramide phosphate) Oral CapsuleSY4c02f1b8-4493-429c-b9f7-21f364e330f82
209066Norpace (as disopyramide phosphate) 100 MG Oral CapsuleSY4c02f1b8-4493-429c-b9f7-21f364e330f82
209066Norpace 100 MG Oral CapsuleSY4c02f1b8-4493-429c-b9f7-21f364e330f82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0025-2732-3100025273231100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0025-2732-31) 1982-07-200000-00-00NoNoCurrent