Hydroxyprogesterone Caproate

Product NDC
66993-039
11-digit product format
669930039
Labeler code
66993
Product ID
66993-039_93786de0-25a2-4b63-b580-5d191e953365
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyprogesterone caproate
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Prasco Laboratories
Application
NDA021945
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2018-07-02
Marketing end
0000-00-00
Substance
HYDROXYPROGESTERONE CAPROATE
Active strength
250 mg/mL
Pharmacologic classes
Progesterone Congeners [CS],Progestin [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
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 productproduct66993-039DDiscontinued by firm2026-08-17
excluded packagepackage66993-03966993-039-01DDiscontinued by firm2026-08-17

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66993-039-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66993-039-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66993-039-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66993-039-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66993-039-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66993-039-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66993-039-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66993-039-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66993-039-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66993-039-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage66993-039-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66993-039-01557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog.

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 · 54 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021945-001MAKENA1250MG/5ML (250MG/ML)SOLUTION / INTRAMUSCULARAP1RLD, RS2011-02-035c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021945-002MAKENA PRESERVATIVE FREE250MG/ML (250MG/ML)SOLUTION / INTRAMUSCULARAPRLD, RS2016-02-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021945-004MAKENA (AUTOINJECTOR)275MG/1.1ML (250MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-02-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021945-001MAKENA1250MG/5ML (250MG/ML)SOLUTION / INTRAMUSCULARAP1RLD, RS2011-02-035d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021945-002MAKENA PRESERVATIVE FREE250MG/ML (250MG/ML)SOLUTION / INTRAMUSCULARAPRLD, RS2016-02-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021945-004MAKENA (AUTOINJECTOR)275MG/1.1ML (250MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-02-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021945-001MAKENA1250MG/5ML (250MG/ML)SOLUTION / INTRAMUSCULARAP1RLD, RS2011-02-034b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021945-002MAKENA PRESERVATIVE FREE250MG/ML (250MG/ML)SOLUTION / INTRAMUSCULARAPRLD, RS2016-02-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021945-004MAKENA (AUTOINJECTOR)275MG/1.1ML (250MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-02-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021945-001MAKENA1250MG/5ML (250MG/ML)SOLUTION / INTRAMUSCULARAP1RLD, RS2011-02-0374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021945-002MAKENA PRESERVATIVE FREE250MG/ML (250MG/ML)SOLUTION / INTRAMUSCULARAPRLD, RS2016-02-1974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021945-004MAKENA (AUTOINJECTOR)275MG/1.1ML (250MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-02-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021945-001MAKENA1250MG/5ML (250MG/ML)SOLUTION / INTRAMUSCULARAP1RLD, RS2011-02-03bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021945-002MAKENA PRESERVATIVE FREE250MG/ML (250MG/ML)SOLUTION / INTRAMUSCULARAPRLD, RS2016-02-19bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021945-004MAKENA (AUTOINJECTOR)275MG/1.1ML (250MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-02-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021945-001MAKENA1250MG/5ML (250MG/ML)SOLUTION / INTRAMUSCULARAP1RLD, RS2011-02-03782e0a99824c…
2021-12-28 21:50 UTC2021-12N021945-002MAKENA PRESERVATIVE FREE250MG/ML (250MG/ML)SOLUTION / INTRAMUSCULARAPRLD, RS2016-02-19782e0a99824c…
2021-12-28 21:50 UTC2021-12N021945-004MAKENA (AUTOINJECTOR)275MG/1.1ML (250MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-02-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021945-001MAKENA1250MG/5ML (250MG/ML)SOLUTION / INTRAMUSCULARAP1RLD, RS2011-02-0387673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021945-002MAKENA PRESERVATIVE FREE250MG/ML (250MG/ML)SOLUTION / INTRAMUSCULARAPRLD, RS2016-02-1987673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021945-004MAKENA (AUTOINJECTOR)275MG/1.1ML (250MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-02-1487673890dc5c…
2021-03-12 10:30 UTC2021-03N021945-001MAKENA1250MG/5ML (250MG/ML)SOLUTION / INTRAMUSCULARAP1RLD, RS2011-02-035aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021945-002MAKENA PRESERVATIVE FREE250MG/ML (250MG/ML)SOLUTION / INTRAMUSCULARAPRLD, RS2016-02-195aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021945-004MAKENA (AUTOINJECTOR)275MG/1.1ML (250MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-02-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021945-001MAKENA1250MG/5ML (250MG/ML)SOLUTION / INTRAMUSCULARAP1RLD, RS2011-02-038869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021945-002MAKENA PRESERVATIVE FREE250MG/ML (250MG/ML)SOLUTION / INTRAMUSCULARAPRLD, RS2016-02-198869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021945-004MAKENA (AUTOINJECTOR)275MG/1.1ML (250MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-02-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021945-001MAKENA1250MG/5ML (250MG/ML)SOLUTION / INTRAMUSCULARAP1RLD, RS2011-02-03c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021945-002MAKENA PRESERVATIVE FREE250MG/ML (250MG/ML)SOLUTION / INTRAMUSCULARAPRLD, RS2016-02-19c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021945-004MAKENA (AUTOINJECTOR)275MG/1.1ML (250MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-02-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021945-001MAKENA1250MG/5ML (250MG/ML)SOLUTION / INTRAMUSCULARAP1RLD, RS2011-02-033f01610625f2…
2019-12-14 00:12 UTC2019-12N021945-002MAKENA PRESERVATIVE FREE250MG/ML (250MG/ML)SOLUTION / INTRAMUSCULARAPRLD, RS2016-02-193f01610625f2…
2019-12-14 00:12 UTC2019-12N021945-004MAKENA (AUTOINJECTOR)275MG/1.1ML (250MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-02-143f01610625f2…
2019-09-15 20:21 UTC2019-09N021945-001MAKENA1250MG/5ML (250MG/ML)SOLUTION / INTRAMUSCULARAP1RLD, RS2011-02-03b00525d2431f…
2019-09-15 20:21 UTC2019-09N021945-002MAKENA PRESERVATIVE FREE250MG/ML (250MG/ML)SOLUTION / INTRAMUSCULARAPRLD, RS2016-02-19b00525d2431f…
2019-09-15 20:21 UTC2019-09N021945-004MAKENA (AUTOINJECTOR)275MG/1.1ML (250MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-02-14b00525d2431f…
2019-07-19 19:46 UTC2019-07N021945-001MAKENA1250MG/5ML (250MG/ML)SOLUTION / INTRAMUSCULARAP1RLD, RS2011-02-03ea99ee380514…
2019-07-19 19:46 UTC2019-07N021945-002MAKENA PRESERVATIVE FREE250MG/ML (250MG/ML)SOLUTION / INTRAMUSCULARAPRLD, RS2016-02-19ea99ee380514…
2019-07-19 19:46 UTC2019-07N021945-004MAKENA (AUTOINJECTOR)275MG/1.1ML (250MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2018-02-14ea99ee380514…
2023-01-26 05:58 UTC2023-01N021945-001MAKENA1250MG/5ML (250MG/ML)SOLUTION / INTRAMUSCULARAP1RLD, RS2011-02-033bdfa0b2c4d7…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021945-001AP115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021945-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021945-001AP115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021945-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021945-001AP114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021945-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021945-001AP1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021945-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021945-001AP11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021945-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021945-001AP11782e0a99824c…
2021-12-28 21:50 UTC2021-12N021945-002AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021945-001AP1187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021945-002AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N021945-001AP115aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021945-002AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021945-001AP118869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021945-002AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021945-001AP11c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021945-002AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021945-001AP113f01610625f2…
2019-12-14 00:12 UTC2019-12N021945-002AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N021945-001AP11b00525d2431f…
2019-09-15 20:21 UTC2019-09N021945-002AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021945-001AP11ea99ee380514…
2019-07-19 19:46 UTC2019-07N021945-002AP1ea99ee380514…
2023-01-26 05:58 UTC2023-01N021945-001AP113bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N021945-002AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021945-001AP113a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021945-002AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021945-001AP11f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N021945-002AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021945-001AP11e64feba35796…
2022-09-29 23:25 UTC2022-09N021945-002AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021945-001AP11cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021945-002AP1cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 5 · 165 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021945-00485625642026-01-24Drug product2018-03-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021945-00491802592026-01-24Drug product2018-03-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021945-00495331022026-01-24Drug product2018-03-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021945-00496299592026-01-24Drug product2018-03-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021945-00480213352026-10-04Drug product2018-03-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021945-00497892572034-02-11Drug product2018-03-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021945-004104710752036-05-02U-22362019-11-185c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021945-004111545622036-05-02U-22362021-11-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021945-004113049622036-05-02U-22362022-05-105c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021945-00498445582036-05-02U-22362018-03-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021945-00485625642026-01-24Drug product2018-03-025d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021945-00491802592026-01-24Drug product2018-03-025d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021945-00495331022026-01-24Drug product2018-03-025d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021945-00496299592026-01-24Drug product2018-03-025d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021945-00480213352026-10-04Drug product2018-03-025d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021945-00497892572034-02-11Drug product2018-03-025d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021945-004104710752036-05-02U-22362019-11-185d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021945-004111545622036-05-02U-22362021-11-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021945-00498445582036-05-02U-22362018-03-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021945-00485625642026-01-24Drug product2018-03-024b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021945-00491802592026-01-24Drug product2018-03-024b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021945-00495331022026-01-24Drug product2018-03-024b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021945-00496299592026-01-24Drug product2018-03-024b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021945-00480213352026-10-04Drug product2018-03-024b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021945-00497892572034-02-11Drug product2018-03-024b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021945-004104710752036-05-02U-22362019-11-184b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021945-004111545622036-05-02U-22362021-11-174b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021945-00498445582036-05-02U-22362018-03-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021945-004RE448462019-08-10Drug product2018-03-0274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021945-00485625642026-01-24Drug product2018-03-0274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021945-00491802592026-01-24Drug product2018-03-0274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021945-00495331022026-01-24Drug product2018-03-0274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021945-00496299592026-01-24Drug product2018-03-0274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021945-00480213352026-10-04Drug product2018-03-0274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021945-00497892572034-02-11Drug product2018-03-0274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021945-00498445582036-05-02U-22362018-03-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021945-00485625642026-01-24Drug product2018-03-02bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021945-00491802592026-01-24Drug product2018-03-02bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021945-00495331022026-01-24Drug product2018-03-02bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021945-00496299592026-01-24Drug product2018-03-02bb7c543d1eb4…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66993-039-01ML - Milliliter66993-03915f4a75e-0c3b-44ca-84f6-d49cbae3082712018-09-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
66993-039-01669930039011 VIAL, GLASS in 1 CARTON (66993-039-01) > 5 mL in 1 VIAL, GLASS2018-07-020000-00-00NoNoCurrent