PROCHLORPERAZINE MALEATE

Product NDC
69452-309
Requested package NDC
69452-309-32
11-digit product format
694520309
Labeler code
69452
Product ID
69452-309_2f9f880c-a70d-317b-e063-6294a90a2280
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prochlorperazine Maleate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA217478
Marketing category
ANDA
Marketing start
2023-09-13
Substance
PROCHLORPERAZINE MALEATE
Active strength
5 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 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
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 · 46 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A217478-001PROCHLORPERAZINE 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…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A217478-001PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORALAB2023-04-04a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A217478-002PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORALAB2023-04-04a67488948f0b…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 46 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A217478-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A217478-002AB1a67488948f0b…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROCHLORPERAZINE MALEATE5 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
052d351a-978b-6fc3-e063-6294a90aef55Available 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
69452-309-20PROCHLORPERAZINE MALEATE100 in 1 BOTTLETABLET, FILM COATED1002
69452-309-32PROCHLORPERAZINE MALEATE1000 in 1 BOTTLETABLET, FILM COATED10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69452-309-20EA - Each69452-3099d91d46d-1e77-4e62-8301-133db4a5158212024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-309PROCHLORPERAZINE MALEATE TABLET, FILM COATED [BIONPHARMA INC.]2Current NDC, 2 package rows20250308_052d351a-978b-6fc3-e063-6294a90aef55.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
ndc (package): 69452-309-32
ndc (product): 69452-309
ndc11 (package): 69452030932
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEBionpharma Inc.2cf363d6-b9e4-2c22-e063-6394a90a76492025-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217478
application number: ANDA217478
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
312635prochlorperazine maleate 5 MG Oral TabletPSN18988af8-545a-3b69-e063-6394a90ae0743
312635prochlorperazine maleate 5 MG Oral TabletPSN86102abe-0b72-4352-95ce-db88d2e140023
312635prochlorperazine 5 MG Oral TabletSCD18988af8-545a-3b69-e063-6394a90ae0743
312635prochlorperazine 5 MG Oral TabletSCD86102abe-0b72-4352-95ce-db88d2e140023
312635prochlorperazine 5 MG (as prochlorperazine maleate) Oral TabletSY18988af8-545a-3b69-e063-6394a90ae0743
312635prochlorperazine 5 MG (as prochlorperazine maleate) Oral TabletSY86102abe-0b72-4352-95ce-db88d2e140023
198365prochlorperazine maleate 10 MG Oral TabletPSN052d351a-978b-6fc3-e063-6294a90aef552
312635prochlorperazine maleate 5 MG Oral TabletPSN052d351a-978b-6fc3-e063-6294a90aef552
198365prochlorperazine 10 MG Oral TabletSCD052d351a-978b-6fc3-e063-6294a90aef552
312635prochlorperazine 5 MG Oral TabletSCD052d351a-978b-6fc3-e063-6294a90aef552
198365prochlorperazine (as prochlorperazine maleate) 10 MG Oral TabletSY052d351a-978b-6fc3-e063-6294a90aef552
312635prochlorperazine 5 MG (as prochlorperazine maleate) Oral TabletSY052d351a-978b-6fc3-e063-6294a90aef552
312635prochlorperazine maleate 5 MG Oral TabletPSN3ccd11d3-5e5e-4ed8-9b0c-49b0a84535ab1
312635prochlorperazine 5 MG Oral TabletSCD3ccd11d3-5e5e-4ed8-9b0c-49b0a84535ab1
312635prochlorperazine 5 MG (as prochlorperazine maleate) Oral TabletSY3ccd11d3-5e5e-4ed8-9b0c-49b0a84535ab1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69452-309-32694520309321000 TABLET, FILM COATED in 1 BOTTLE (69452-309-32) 2023-09-13NoNoCurrent