Compro

Product NDC
0574-7226
11-digit product format
005747226
Labeler code
0574
Product ID
0574-7226_4135b435-2e63-49fd-aa69-d05bcaa2eaf9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROCHLORPERAZINE
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Padagis US LLC
Application
ANDA040246
Marketing category
ANDA
Marketing start
2000-09-01
Substance
PROCHLORPERAZINE
Active strength
25 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040246-001COMPROPROCHLORPERAZINE25MGSUPPOSITORY / RECTALAB2000-06-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040246-001AB

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040246-001COMPRO25MGSUPPOSITORY / RECTALAB2000-06-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040246-001COMPRO25MGSUPPOSITORY / RECTALAB2000-06-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040246-001COMPRO25MGSUPPOSITORY / RECTALAB2000-06-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A040246-001COMPRO25MGSUPPOSITORY / RECTALAB2000-06-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040246-001COMPRO25MGSUPPOSITORY / RECTALAB2000-06-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040246-001COMPRO25MGSUPPOSITORY / RECTALAB2000-06-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040246-001COMPRO25MGSUPPOSITORY / RECTALAB2000-06-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040246-001COMPRO25MGSUPPOSITORY / RECTALAB2000-06-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040246-001COMPRO25MGSUPPOSITORY / RECTALAB2000-06-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040246-001COMPRO25MGSUPPOSITORY / RECTALAB2000-06-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040246-001COMPRO25MGSUPPOSITORY / RECTALAB2000-06-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040246-001COMPRO25MGSUPPOSITORY / RECTALAB2000-06-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040246-001COMPRO25MGSUPPOSITORY / RECTALAB2000-06-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040246-001COMPRO25MGSUPPOSITORY / RECTALAB2000-06-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040246-001COMPRO25MGSUPPOSITORY / RECTALAB2000-06-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040246-001COMPRO25MGSUPPOSITORY / RECTALAB2000-06-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040246-001COMPRO25MGSUPPOSITORY / RECTALAB2000-06-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040246-001COMPRO25MGSUPPOSITORY / RECTALAB2000-06-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040246-001COMPRO25MGSUPPOSITORY / RECTALAB2000-06-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040246-001COMPRO25MGSUPPOSITORY / RECTALAB2000-06-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040246-001COMPRO25MGSUPPOSITORY / RECTALAB2000-06-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040246-001COMPRO25MGSUPPOSITORY / RECTALAB2000-06-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A040246-001COMPRO25MGSUPPOSITORY / RECTALAB2000-06-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040246-001COMPRO25MGSUPPOSITORY / RECTALAB2000-06-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040246-001COMPRO25MGSUPPOSITORY / RECTALAB2000-06-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040246-001COMPRO25MGSUPPOSITORY / RECTALAB2000-06-283f01610625f2…
2019-09-15 20:21 UTC2019-09A040246-001COMPRO25MGSUPPOSITORY / RECTALAB2000-06-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A040246-001COMPRO25MGSUPPOSITORY / RECTALAB2000-06-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040246-001COMPRO25MGSUPPOSITORY / RECTALAB2000-06-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040246-001COMPRO25MGSUPPOSITORY / RECTALAB2000-06-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040246-001COMPRO25MGSUPPOSITORY / RECTALAB2000-06-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040246-001COMPRO25MGSUPPOSITORY / RECTALAB2000-06-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040246-001COMPRO25MGSUPPOSITORY / RECTALAB2000-06-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040246-001COMPRO25MGSUPPOSITORY / RECTALAB2000-06-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040246-001COMPRO25MGSUPPOSITORY / RECTALAB2000-06-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A040246-001COMPRO25MGSUPPOSITORY / RECTALAB2000-06-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A040246-001COMPRO25MGSUPPOSITORY / RECTALAB2000-06-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040246-001COMPRO25MGSUPPOSITORY / RECTALAB2000-06-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040246-001COMPRO25MGSUPPOSITORY / RECTALAB2000-06-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040246-001COMPRO25MGSUPPOSITORY / RECTALAB2000-06-28e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A040246-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040246-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040246-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040246-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040246-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040246-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040246-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040246-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040246-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040246-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040246-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040246-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040246-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040246-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040246-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040246-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040246-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040246-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040246-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040246-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040246-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040246-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A040246-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040246-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040246-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040246-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A040246-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040246-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040246-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040246-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040246-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040246-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040246-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040246-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040246-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040246-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040246-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040246-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040246-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040246-001AB1e64feba35796…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROCHLORPERAZINE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
YHP6YLT61TInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198159Internal RxNorm lookup
284254Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ea381bc5-0957-4c91-826a-0ff680cebaccAvailable 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
0574-7226-12Compro12 in 1 CARTONSUPPOSITORY1212
0574-7226-12Compro1 in 1 PACKETSUPPOSITORY112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0574-7226-12EA - Each0574-722650603081-2e07-47d4-a8a4-da632d31b72b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROCHLORPERAZINEACTIVE INGREDIENTYHP6YLT61TCOMPRO (PROCHLORPERAZINE) SUPPOSITORY [PADDOCK LABORATORIES, LLC]6
PROCHLORPERAZINEACTIVE MOIETYYHP6YLT61TCOMPRO (PROCHLORPERAZINE) SUPPOSITORY [PADDOCK LABORATORIES, LLC]6
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOMPRO (PROCHLORPERAZINE) SUPPOSITORY [PADDOCK LABORATORIES, LLC]6
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4COMPRO (PROCHLORPERAZINE) SUPPOSITORY [PADDOCK LABORATORIES, LLC]6
GLYCERYL PALMITATEINACTIVE INGREDIENT6Y2XJ05B35COMPRO (PROCHLORPERAZINE) SUPPOSITORY [PADDOCK LABORATORIES, LLC]6
HYDROGENATED COCONUT OILINACTIVE INGREDIENTJY81OXM1OMCOMPRO (PROCHLORPERAZINE) SUPPOSITORY [PADDOCK LABORATORIES, LLC]6
HYDROGENATED PALM KERNEL OILINACTIVE INGREDIENTFM8D1RE2VPCOMPRO (PROCHLORPERAZINE) SUPPOSITORY [PADDOCK LABORATORIES, LLC]6
PROCHLORPERAZINEACTIVE INGREDIENTYHP6YLT61TCOMPRO (PROCHLORPERAZINE) SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]5
PROCHLORPERAZINEACTIVE MOIETYYHP6YLT61TCOMPRO (PROCHLORPERAZINE) SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOMPRO (PROCHLORPERAZINE) SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]5
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4COMPRO (PROCHLORPERAZINE) SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]5
HYDROGENATED COCONUT OILINACTIVE INGREDIENTJY81OXM1OMCOMPRO (PROCHLORPERAZINE) SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]5
PALM KERNEL OILINACTIVE INGREDIENTB0S90M0233COMPRO (PROCHLORPERAZINE) SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0574-7226COMPRO (PROCHLORPERAZINE) SUPPOSITORY [PADAGIS US LLC]12Current NDC, Legacy NDC, 2 package rows20241123_ea381bc5-0957-4c91-826a-0ff680cebacc.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ComproPROCHLORPERAZINEPD-Rx Pharmaceuticals, Inc.b23b67eb-78b7-48eb-84ff-c95d3ce8683c2025-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040246
application number: ANDA040246
ComproPROCHLORPERAZINEPadagis US LLCea381bc5-0957-4c91-826a-0ff680cebacc2024-11-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040246
application number: ANDA040246
ndc (product): 0574-7226

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284254Compro 25 MG Rectal SuppositoryPSNb23b67eb-78b7-48eb-84ff-c95d3ce8683c16
198159prochlorperazine 25 MG Rectal SuppositoryPSNb23b67eb-78b7-48eb-84ff-c95d3ce8683c16
284254prochlorperazine 25 MG Rectal Suppository [Compro]SBDb23b67eb-78b7-48eb-84ff-c95d3ce8683c16
198159prochlorperazine 25 MG Rectal SuppositorySCDb23b67eb-78b7-48eb-84ff-c95d3ce8683c16
284254Compro 25 MG Rectal SuppositorySYb23b67eb-78b7-48eb-84ff-c95d3ce8683c16
284254Compro 25 MG Rectal SuppositoryPSNea381bc5-0957-4c91-826a-0ff680cebacc12
198159prochlorperazine 25 MG Rectal SuppositoryPSNea381bc5-0957-4c91-826a-0ff680cebacc12
284254prochlorperazine 25 MG Rectal Suppository [Compro]SBDea381bc5-0957-4c91-826a-0ff680cebacc12
198159prochlorperazine 25 MG Rectal SuppositorySCDea381bc5-0957-4c91-826a-0ff680cebacc12
284254Compro 25 MG Rectal SuppositorySYea381bc5-0957-4c91-826a-0ff680cebacc12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0574-7226-120057472261212 PACKET in 1 CARTON (0574-7226-12) / 1 SUPPOSITORY in 1 PACKET12 packet2000-09-010000-00-00NoNoCurrent