Hydroxyprogesterone Caproate

Product NDC: 69238-1797
11-digit product format: 692381797
Labeler code: 69238
Product ID: 69238-1797_69e5d090-659a-48d7-870f-d6014743d263
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxyprogesterone Caproate
Dosage form: INJECTION
Route: INTRAMUSCULAR
Labeler: Amneal Pharmaceuticals of NY LLC
Application: ANDA210723
Marketing category: ANDA
Marketing start: 2019-03-11
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: 2023-12-31
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	69238-1797		I	Inactivated by FDA		2026-08-17
excluded package	package	69238-1797	69238-1797-1	I	Inactivated by FDA		2026-08-17

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 · 34 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69238-1797-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69238-1797-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69238-1797-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69238-1797-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69238-1797-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69238-1797-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69238-1797-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69238-1797-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69238-1797-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69238-1797-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69238-1797-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69238-1797-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69238-1797-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69238-1797-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69238-1797-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69238-1797-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69238-1797-1	`bd6a592717d7…`	`303034d00443…`

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210723-001	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	2018-06-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210723-001	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	2018-06-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210723-001	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	2018-06-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210723-001	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	2018-06-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210723-001	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	2018-06-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210723-001	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	2018-06-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210723-001	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	2018-06-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210723-001	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	2018-06-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210723-001	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	2018-06-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210723-001	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	2018-06-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210723-001	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	2018-06-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210723-001	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	2018-06-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210723-001	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	2018-06-21	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	A210723-001	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	2018-06-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210723-001	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	2018-06-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210723-001	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	2018-06-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210723-001	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	2018-06-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210723-001	HYDROXYPROGESTERONE CAPROATE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	2018-06-21	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210723-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210723-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210723-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210723-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210723-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210723-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210723-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210723-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210723-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210723-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210723-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210723-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210723-001	AP	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	A210723-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210723-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210723-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210723-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210723-001	AP	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3f8ce7d0-fe1e-f6af-e620-f015de6193ca	Product name	5	20200123
fc034902-c257-4d88-ae77-2436fbeafed3	Product name	2	20200121
2286aae4-2877-44f1-aa6e-273758ac39a3	Product name	2	20190628

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69238-1797-1	2024-01-30	C162847	48780-1	d6a99b39-f84a-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use HYDROXYPROGESTERONE CAPROATE INJECTION safely and effectively. See full prescribing information for HYDROXYPROGESTERONE CAPROATE INJECTION. HYDROXYPROGESTERONE CAPROATE injection, for intramuscular use. Initial U.S. Approval: 1956
69238-1797-1	2022-04-11	C162847	48780-1	d6a99b39-f84a-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use HYDROXYPROGESTERONE CAPROATE INJECTION safely and effectively. See full prescribing information for HYDROXYPROGESTERONE CAPROATE INJECTION. HYDROXYPROGESTERONE CAPROATE injection, for intramuscular use. Initial U.S. Approval: 1956
69238-1797-1	2022-01-28	C162847	48780-1	d6a99b39-f84a-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use HYDROXYPROGESTERONE CAPROATE INJECTION safely and effectively. See full prescribing information for HYDROXYPROGESTERONE CAPROATE INJECTION. HYDROXYPROGESTERONE CAPROATE injection, for intramuscular use. Initial U.S. Approval: 1956

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69238-1797-1	Hydroxyprogesterone Caproate	1 in 1 BOX	INJECTION	1		13
69238-1797-1	Hydroxyprogesterone Caproate	1 mL in 1 VIAL	INJECTION	1		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69238-1797-1	ML - Milliliter	69238-1797	34f763ab-fca0-4280-b067-ed315a5d6008	1	2019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69238-1797	HYDROXYPROGESTERONE CAPROATE INJECTION [AMNEAL PHARMACEUTICALS OF NY LLC]	13	Legacy NDC, 2 package rows	20220415_79cd136b-2098-43a4-aeec-7d8b8869f6ae.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
276F2O42F5	HYDROXYPROGESTERONE CAPROATE	630-56-8	HYDROXYPROGESTERONE CAPROATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1796690	HYDROXYprogesterone caproate 250 MG in 1 ML Injection	PSN	79cd136b-2098-43a4-aeec-7d8b8869f6ae	13
1796690	1 ML hydroxyprogesterone caproate (USP) 250 MG/ML Injection	SCD	79cd136b-2098-43a4-aeec-7d8b8869f6ae	13
1796690	hydroxyprogesterone caproate 250 MG per 1 ML Injection	SY	79cd136b-2098-43a4-aeec-7d8b8869f6ae	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69238-1797-1	69238179701	1 VIAL in 1 BOX (69238-1797-1) > 1 mL in 1 VIAL	1 vial	2019-03-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydroxyprogesterone Caproate	Amneal Pharmaceuticals of NY LLC \| American Regent, Inc.	2018-08-01	HUMAN PRESCRIPTION DRUG LABEL	13