Norpace

Product NDC
68151-0527
11-digit product format
681510527
Labeler code
68151
Product ID
68151-0527_ab01df3a-64fa-41c8-a5f3-e71003d5b298
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
disopyramide phosphate
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Carilion Materials Management
Application
NDA018655
Marketing category
NDA
Marketing start
1982-07-20
Marketing end
0000-00-00
Substance
DISOPYRAMIDE PHOSPHATE
Active strength
150 mg/1
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68151-0527IInactivated by FDA2026-08-07
excluded packagepackage68151-052768151-0527-3IInactivated by FDA2026-08-07

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68151-0527-3IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68151-0527-3IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68151-0527-3IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68151-0527-3IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68151-0527-3IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68151-0527-3IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68151-0527-3IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68151-0527-3IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68151-0527-3IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68151-0527-3IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68151-0527-3IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68151-0527-3IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68151-0527-3IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68151-0527-3IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68151-0527-3IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68151-0527-3IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68151-0527-3IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68151-0527-3IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68151-0527-3IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage68151-0527-3IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage68151-0527-3IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage68151-0527-3EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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…

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68151-0527-32020-01-31C16284748780-19d75b9d0-9ffd-f424-e053-dadaa90a57ceNorpace disopyramide phosphate capsules Norpace CR disopyramide phosphate extended-release capsules ® ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-0527-3Norpace1 in 1 PACKAGECAPSULE, GELATIN COATED12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNORPACE (DISOPYRAMIDE PHOSPHATE) CAPSULE, GELATIN COATED [CARILION MATERIALS MANAGEMENT]2
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYNORPACE (DISOPYRAMIDE PHOSPHATE) CAPSULE, GELATIN COATED [CARILION MATERIALS MANAGEMENT]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NORPACE (DISOPYRAMIDE PHOSPHATE) CAPSULE, GELATIN COATED [CARILION MATERIALS MANAGEMENT]2
GELATININACTIVE INGREDIENT2G86QN327LNORPACE (DISOPYRAMIDE PHOSPHATE) CAPSULE, GELATIN COATED [CARILION MATERIALS MANAGEMENT]2
SHELLACINACTIVE INGREDIENT46N107B71ONORPACE (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
68151-0527NORPACE (DISOPYRAMIDE PHOSPHATE) CAPSULE, GELATIN COATED [CARILION MATERIALS MANAGEMENT]2Legacy NDC, 1 package rows20140707_f5e0c230-db38-4476-8357-9a227ccff1bc.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309960disopyramide phosphate 150 MG Oral CapsulePSNf5e0c230-db38-4476-8357-9a227ccff1bc2
209692Norpace 150 MG Oral CapsulePSNf5e0c230-db38-4476-8357-9a227ccff1bc2
209692disopyramide 150 MG Oral Capsule [Norpace]SBDf5e0c230-db38-4476-8357-9a227ccff1bc2
309960disopyramide 150 MG Oral CapsuleSCDf5e0c230-db38-4476-8357-9a227ccff1bc2
309960disopyramide 150 MG (as disopyramide phosphate) Oral CapsuleSYf5e0c230-db38-4476-8357-9a227ccff1bc2
209692Norpace (as disopyramide phosphate) 150 MG Oral CapsuleSYf5e0c230-db38-4476-8357-9a227ccff1bc2
209692Norpace 150 MG Oral CapsuleSYf5e0c230-db38-4476-8357-9a227ccff1bc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-0527-3681510527031 in 1 PACKAGEHistorical