PROCHLORPERAZINE MALEATE

Product NDC
69452-472
11-digit product format
694520472
Labeler code
69452
Product ID
69452-472_2cf363d6-b9e5-2c22-e063-6394a90a7649
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prochlorperazine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA217478
Marketing category
ANDA
Marketing start
2025-01-31
Substance
PROCHLORPERAZINE MALEATE
Active strength
10 mg/1
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A217478-001PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORALAB2023-04-04
A217478-002PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORALAB2023-04-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A217478-001AB
A217478-002AB

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 2 · 48 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A217478-001PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORALAB2023-04-04caaa826d4ba7…
2026-08-18 06:07:402026-07A217478-002PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORALAB2023-04-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217478-001PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORALAB2023-04-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217478-002PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORALAB2023-04-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217478-001PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORALAB2023-04-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217478-002PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORALAB2023-04-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A217478-001PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORALAB2023-04-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217478-002PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORALAB2023-04-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217478-001PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORALAB2023-04-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217478-002PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORALAB2023-04-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217478-001PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORALAB2023-04-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217478-002PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORALAB2023-04-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217478-001PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORALAB2023-04-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217478-002PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORALAB2023-04-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217478-001PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORALAB2023-04-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217478-002PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORALAB2023-04-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217478-001PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORALAB2023-04-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217478-002PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORALAB2023-04-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217478-001PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORALAB2023-04-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217478-002PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORALAB2023-04-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217478-001PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORALAB2023-04-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A217478-002PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORALAB2023-04-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217478-001PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORALAB2023-04-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217478-002PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORALAB2023-04-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217478-001PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORALAB2023-04-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217478-002PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORALAB2023-04-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217478-001PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORALAB2023-04-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217478-002PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORALAB2023-04-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217478-001PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORALAB2023-04-048072bd15b7f6…
2024-05-31 18:47 UTC2024-05A217478-002PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORALAB2023-04-048072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217478-001PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORALAB2023-04-046a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217478-002PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORALAB2023-04-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A217478-001PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORALAB2023-04-041c564ffb4f44…
2024-02-18 07:12 UTC2024-02A217478-002PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORALAB2023-04-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12A217478-001PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORALAB2023-04-04ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A217478-002PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORALAB2023-04-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217478-001PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORALAB2023-04-04a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217478-002PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORALAB2023-04-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A217478-001PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORALAB2023-04-049b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A217478-002PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORALAB2023-04-049b2671bbb829…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A217478-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A217478-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217478-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217478-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217478-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217478-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217478-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217478-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217478-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217478-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217478-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217478-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217478-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217478-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217478-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217478-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217478-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217478-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217478-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217478-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217478-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A217478-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217478-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217478-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217478-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217478-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217478-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217478-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217478-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A217478-002AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217478-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217478-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A217478-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A217478-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A217478-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A217478-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217478-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217478-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A217478-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A217478-002AB19b2671bbb829…

Additional Listing Data#

Finished product
Yes
Brand name base
PROCHLORPERAZINE MALEATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROCHLORPERAZINE MALEATE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
I1T8O1JTL6Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198365Internal RxNorm lookup
312635Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2cf363d6-b9e4-2c22-e063-6394a90a7649Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9bfe4595-32b8-9175-3af8-875e9c4c0538Product name620260305
7335ddeb-6cbd-135c-487d-96fa4587ad65Product name620250331
a6ffe0a0-7823-b305-75e9-2a5c6f2be4acProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69452-472-20PROCHLORPERAZINE MALEATE100 in 1 BOTTLETABLET1001
69452-472-32PROCHLORPERAZINE MALEATE1000 in 1 BOTTLETABLET10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69452-472-20EA - Each69452-47224d5ce6e-dc33-466e-96f1-2025c324fefa12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-472PROCHLORPERAZINE MALEATE TABLET [BIONPHARMA INC.]1Current NDC, 2 package rows20250202_2cf363d6-b9e4-2c22-e063-6394a90a7649.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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATERedpharm Drug44f278eb-3588-af83-e063-6394a90a73cf2025-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217478
application number: ANDA217478
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEA-S Medication Solutionsf387b07a-2d99-4fd5-bcd1-8f04e69b8a392025-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217478
application number: ANDA217478
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATERedpharm Drug3dd03606-1f58-43ac-e063-6294a90a44392025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217478
application number: ANDA217478
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEREMEDYREPACK INC.c622550a-4f61-47f7-bc6b-9545d5d4e0312025-10-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217478
application number: ANDA217478
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEPreferred Pharmaceuticals Inc.f3adc8a4-2c2b-4d5e-803f-38361966cc682025-09-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217478
application number: ANDA217478
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEBryant Ranch Prepacka826f111-4186-47d3-99c1-a72d75776c4c2025-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217478
application number: ANDA217478
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATERedpharm Drug18988af8-545a-3b69-e063-6394a90ae0742025-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217478
application number: ANDA217478
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEBryant Ranch Prepack3ccd11d3-5e5e-4ed8-9b0c-49b0a84535ab2025-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217478
application number: ANDA217478
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEBionpharma Inc.052d351a-978b-6fc3-e063-6294a90aef552025-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217478
application number: ANDA217478
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEBionpharma Inc.2cf363d6-b9e4-2c22-e063-6394a90a76492025-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217478
application number: ANDA217478
ndc (product): 69452-472
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEA-S Medication Solutions86102abe-0b72-4352-95ce-db88d2e140022024-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217478
application number: ANDA217478

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198365prochlorperazine maleate 10 MG Oral TabletPSN44f278eb-3588-af83-e063-6394a90a73cf2
198365prochlorperazine 10 MG Oral TabletSCD44f278eb-3588-af83-e063-6394a90a73cf2
198365prochlorperazine (as prochlorperazine maleate) 10 MG Oral TabletSY44f278eb-3588-af83-e063-6394a90a73cf2
198365prochlorperazine maleate 10 MG Oral TabletPSN2cf363d6-b9e4-2c22-e063-6394a90a76491
312635prochlorperazine maleate 5 MG Oral TabletPSN2cf363d6-b9e4-2c22-e063-6394a90a76491
198365prochlorperazine 10 MG Oral TabletSCD2cf363d6-b9e4-2c22-e063-6394a90a76491
312635prochlorperazine 5 MG Oral TabletSCD2cf363d6-b9e4-2c22-e063-6394a90a76491
198365prochlorperazine (as prochlorperazine maleate) 10 MG Oral TabletSY2cf363d6-b9e4-2c22-e063-6394a90a76491
312635prochlorperazine 5 MG (as prochlorperazine maleate) Oral TabletSY2cf363d6-b9e4-2c22-e063-6394a90a76491

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69452-472-2069452047220100 TABLET in 1 BOTTLE (69452-472-20) 100 tablet2025-01-31NoNoCurrent
69452-472-32694520472321000 TABLET in 1 BOTTLE (69452-472-32) 1000 tablet2025-01-31NoNoCurrent