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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018655-001 | NORPACE CR | DISOPYRAMIDE PHOSPHATE | EQ 100MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-07-20 | |
| N018655-002 | NORPACE CR | DISOPYRAMIDE PHOSPHATE | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 1982-07-20 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N018655-001 | NORPACE CR | EQ 100MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-07-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018655-002 | NORPACE CR | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 1982-07-20 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018655-001 | NORPACE CR | EQ 100MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-07-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018655-002 | NORPACE CR | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 1982-07-20 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018655-001 | NORPACE CR | EQ 100MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-07-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018655-002 | NORPACE CR | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 1982-07-20 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018655-001 | NORPACE CR | EQ 100MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-07-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018655-002 | NORPACE CR | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 1982-07-20 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018655-001 | NORPACE CR | EQ 100MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-07-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018655-002 | NORPACE CR | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 1982-07-20 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018655-001 | NORPACE CR | EQ 100MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-07-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018655-002 | NORPACE CR | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 1982-07-20 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018655-001 | NORPACE CR | EQ 100MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-07-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018655-002 | NORPACE CR | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 1982-07-20 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018655-001 | NORPACE CR | EQ 100MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-07-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018655-002 | NORPACE CR | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 1982-07-20 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018655-001 | NORPACE CR | EQ 100MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-07-20 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018655-002 | NORPACE CR | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 1982-07-20 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N018655-001 | NORPACE CR | EQ 100MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-07-20 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N018655-002 | NORPACE CR | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 1982-07-20 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018655-001 | NORPACE CR | EQ 100MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-07-20 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018655-002 | NORPACE CR | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 1982-07-20 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018655-001 | NORPACE CR | EQ 100MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-07-20 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018655-002 | NORPACE CR | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 1982-07-20 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018655-001 | NORPACE CR | EQ 100MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-07-20 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018655-002 | NORPACE CR | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 1982-07-20 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N018655-001 | NORPACE CR | EQ 100MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-07-20 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N018655-002 | NORPACE CR | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 1982-07-20 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018655-001 | NORPACE CR | EQ 100MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-07-20 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018655-002 | NORPACE CR | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 1982-07-20 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N018655-001 | NORPACE CR | EQ 100MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-07-20 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N018655-002 | NORPACE CR | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 1982-07-20 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N018655-001 | NORPACE CR | EQ 100MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-07-20 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N018655-002 | NORPACE CR | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 1982-07-20 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N018655-001 | NORPACE CR | EQ 100MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-07-20 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N018655-002 | NORPACE CR | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 1982-07-20 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N018655-001 | NORPACE CR | EQ 100MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-07-20 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N018655-002 | NORPACE CR | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 1982-07-20 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N018655-001 | NORPACE CR | EQ 100MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1982-07-20 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N018655-002 | NORPACE CR | EQ 150MG BASE | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 1982-07-20 | 782e0a99824c… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Norpace CR
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DISOPYRAMIDE PHOSPHATE | 100 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| N6BOM1935W | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e2aa1642-d262-4520-bc6a-9fd3ad795677 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d08b5e1c-4339-4b83-bd26-a59d84e2a782 | Product name | 1 | 20170614 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0025-2732-31 | Norpace CR | 100 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 100 | 21 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0025-2732-31 | EA - Each | 0025-2732 | b308d85c-b733-44ac-b6ac-e4174ebac31d | 1 | 2012-07-24 |
| 0025-2732-51 | EA - Each | 0025-2732 | 912e8e37-ef5d-4797-a474-faa4c08fd874 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0025-2732 | NORPACE (DISOPYRAMIDE PHOSPHATE) CAPSULE, GELATIN COATED NORPACE CR (DISOPYRAMIDE PHOSPHATE) CAPSULE, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC] | 19 | Current NDC, Legacy NDC, 1 package rows | 20240817_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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Norpace CR | DISOPYRAMIDE PHOSPHATE | Pfizer Laboratories Div Pfizer Inc | e2aa1642-d262-4520-bc6a-9fd3ad795677 | 2026-03-18 | Boxed warning, Warnings, Adverse reactions | 018655 NDA018655 0025-2732 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 636793 | disopyramide phosphate 100 MG 12HR Extended Release Oral Capsule | PSN | e2aa1642-d262-4520-bc6a-9fd3ad795677 | 21 |
| 309958 | disopyramide phosphate 100 MG Oral Capsule | PSN | e2aa1642-d262-4520-bc6a-9fd3ad795677 | 21 |
| 636794 | disopyramide phosphate 150 MG 12HR Extended Release Oral Capsule | PSN | e2aa1642-d262-4520-bc6a-9fd3ad795677 | 21 |
| 309960 | disopyramide phosphate 150 MG Oral Capsule | PSN | e2aa1642-d262-4520-bc6a-9fd3ad795677 | 21 |
| 209066 | Norpace 100 MG Oral Capsule | PSN | e2aa1642-d262-4520-bc6a-9fd3ad795677 | 21 |
| 209692 | Norpace 150 MG Oral Capsule | PSN | e2aa1642-d262-4520-bc6a-9fd3ad795677 | 21 |
| 902648 | Norpace CR 100 MG 12HR Extended Release Oral Capsule | PSN | e2aa1642-d262-4520-bc6a-9fd3ad795677 | 21 |
| 902652 | Norpace CR 150 MG 12HR Extended Release Oral Capsule | PSN | e2aa1642-d262-4520-bc6a-9fd3ad795677 | 21 |
| 902648 | 12 HR disopyramide 100 MG Extended Release Oral Capsule [Norpace] | SBD | e2aa1642-d262-4520-bc6a-9fd3ad795677 | 21 |
| 902652 | 12 HR disopyramide 150 MG Extended Release Oral Capsule [Norpace] | SBD | e2aa1642-d262-4520-bc6a-9fd3ad795677 | 21 |
| 209066 | disopyramide 100 MG Oral Capsule [Norpace] | SBD | e2aa1642-d262-4520-bc6a-9fd3ad795677 | 21 |
| 209692 | disopyramide 150 MG Oral Capsule [Norpace] | SBD | e2aa1642-d262-4520-bc6a-9fd3ad795677 | 21 |
| 636793 | 12 HR disopyramide 100 MG Extended Release Oral Capsule | SCD | e2aa1642-d262-4520-bc6a-9fd3ad795677 | 21 |
| 636794 | 12 HR disopyramide 150 MG Extended Release Oral Capsule | SCD | e2aa1642-d262-4520-bc6a-9fd3ad795677 | 21 |
| 309958 | disopyramide 100 MG Oral Capsule | SCD | e2aa1642-d262-4520-bc6a-9fd3ad795677 | 21 |
| 309960 | disopyramide 150 MG Oral Capsule | SCD | e2aa1642-d262-4520-bc6a-9fd3ad795677 | 21 |
| 902648 | 12 HR Norpace 100 MG Extended Release Oral Capsule | SY | e2aa1642-d262-4520-bc6a-9fd3ad795677 | 21 |
| 902652 | 12 HR Norpace 150 MG Extended Release Oral Capsule | SY | e2aa1642-d262-4520-bc6a-9fd3ad795677 | 21 |
| 309958 | disopyramide 100 MG (as disopyramide phosphate) Oral Capsule | SY | e2aa1642-d262-4520-bc6a-9fd3ad795677 | 21 |
| 636793 | disopyramide 100 MG 12 HR Extended Release Oral Capsule | SY | e2aa1642-d262-4520-bc6a-9fd3ad795677 | 21 |
| 309960 | disopyramide 150 MG (as disopyramide phosphate) Oral Capsule | SY | e2aa1642-d262-4520-bc6a-9fd3ad795677 | 21 |
| 636794 | disopyramide 150 MG 12 HR Extended Release Oral Capsule | SY | e2aa1642-d262-4520-bc6a-9fd3ad795677 | 21 |
| 209066 | Norpace (as disopyramide phosphate) 100 MG Oral Capsule | SY | e2aa1642-d262-4520-bc6a-9fd3ad795677 | 21 |
| 209692 | Norpace (as disopyramide phosphate) 150 MG Oral Capsule | SY | e2aa1642-d262-4520-bc6a-9fd3ad795677 | 21 |
| 209066 | Norpace 100 MG Oral Capsule | SY | e2aa1642-d262-4520-bc6a-9fd3ad795677 | 21 |
| 209692 | Norpace 150 MG Oral Capsule | SY | e2aa1642-d262-4520-bc6a-9fd3ad795677 | 21 |
| 902648 | Norpace CR (as disopyramide phosphate) 100 MG 12 HR Extended Release Oral Capsule | SY | e2aa1642-d262-4520-bc6a-9fd3ad795677 | 21 |
| 902652 | Norpace CR (as disopyramide phosphate) 150 MG 12 HR Extended Release Oral Capsule | SY | e2aa1642-d262-4520-bc6a-9fd3ad795677 | 21 |
| 309958 | disopyramide phosphate 100 MG Oral Capsule | PSN | 4c02f1b8-4493-429c-b9f7-21f364e330f8 | 2 |
| 209066 | Norpace 100 MG Oral Capsule | PSN | 4c02f1b8-4493-429c-b9f7-21f364e330f8 | 2 |
| 209066 | disopyramide 100 MG Oral Capsule [Norpace] | SBD | 4c02f1b8-4493-429c-b9f7-21f364e330f8 | 2 |
| 309958 | disopyramide 100 MG Oral Capsule | SCD | 4c02f1b8-4493-429c-b9f7-21f364e330f8 | 2 |
| 309958 | disopyramide 100 MG (as disopyramide phosphate) Oral Capsule | SY | 4c02f1b8-4493-429c-b9f7-21f364e330f8 | 2 |
| 209066 | Norpace (as disopyramide phosphate) 100 MG Oral Capsule | SY | 4c02f1b8-4493-429c-b9f7-21f364e330f8 | 2 |
| 209066 | Norpace 100 MG Oral Capsule | SY | 4c02f1b8-4493-429c-b9f7-21f364e330f8 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0025-2732-31 | 00025273231 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0025-2732-31) | 1982-07-20 | 0000-00-00 | No | No | Current |