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 FDA2026-08-17
excluded packagepackage68151-052768151-0527-3IInactivated by FDA2026-08-17

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 42.

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N018655-001NORPACE CREQ 100MG BASECAPSULE, EXTENDED RELEASE / ORALRLD1982-07-20caaa826d4ba7…
2026-08-18 06:07:402026-07N018655-002NORPACE CREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALRLD, RS1982-07-20caaa826d4ba7…
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…

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

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