Makena

Product NDC: 64011-247
11-digit product format: 640110247
Labeler code: 64011
Product ID: 64011-247_2586f54d-3cef-46fe-b5e8-1dc9a9861ee3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydroxyprogesterone caproate
Dosage form: INJECTION
Route: INTRAMUSCULAR
Labeler: AMAG Pharmaceuticals, Inc.
Application: NDA021945
Marketing category: NDA
Marketing start: 2011-02-03
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	64011-247		D	Discontinued by firm		2026-08-17
excluded package	package	64011-247	64011-247-02	D	Discontinued by firm		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 · 24 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	64011-247-02	`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	64011-247-02	`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	64011-247-02	`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	64011-247-02	`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	64011-247-02	`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	64011-247-02	`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	64011-247-02	`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	64011-247-02	`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	64011-247-02	`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	64011-247-02	`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	64011-247-02	`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	64011-247-02	`557ba5c1ecfa…`	`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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021945-001	MAKENA	1250MG/5ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP1	RLD, RS	2011-02-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021945-002	MAKENA PRESERVATIVE FREE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	RLD, RS	2016-02-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021945-004	MAKENA (AUTOINJECTOR)	275MG/1.1ML (250MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2018-02-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021945-001	MAKENA	1250MG/5ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP1	RLD, RS	2011-02-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021945-002	MAKENA PRESERVATIVE FREE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	RLD, RS	2016-02-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021945-004	MAKENA (AUTOINJECTOR)	275MG/1.1ML (250MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2018-02-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021945-001	MAKENA	1250MG/5ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP1	RLD, RS	2011-02-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021945-002	MAKENA PRESERVATIVE FREE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	RLD, RS	2016-02-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021945-004	MAKENA (AUTOINJECTOR)	275MG/1.1ML (250MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2018-02-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021945-001	MAKENA	1250MG/5ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP1	RLD, RS	2011-02-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021945-002	MAKENA PRESERVATIVE FREE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	RLD, RS	2016-02-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021945-004	MAKENA (AUTOINJECTOR)	275MG/1.1ML (250MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2018-02-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021945-001	MAKENA	1250MG/5ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP1	RLD, RS	2011-02-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021945-002	MAKENA PRESERVATIVE FREE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	RLD, RS	2016-02-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021945-004	MAKENA (AUTOINJECTOR)	275MG/1.1ML (250MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2018-02-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021945-001	MAKENA	1250MG/5ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP1	RLD, RS	2011-02-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021945-002	MAKENA PRESERVATIVE FREE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	RLD, RS	2016-02-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021945-004	MAKENA (AUTOINJECTOR)	275MG/1.1ML (250MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2018-02-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021945-001	MAKENA	1250MG/5ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP1	RLD, RS	2011-02-03	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021945-002	MAKENA PRESERVATIVE FREE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	RLD, RS	2016-02-19	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021945-004	MAKENA (AUTOINJECTOR)	275MG/1.1ML (250MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2018-02-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021945-001	MAKENA	1250MG/5ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP1	RLD, RS	2011-02-03	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021945-002	MAKENA PRESERVATIVE FREE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	RLD, RS	2016-02-19	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021945-004	MAKENA (AUTOINJECTOR)	275MG/1.1ML (250MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2018-02-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021945-001	MAKENA	1250MG/5ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP1	RLD, RS	2011-02-03	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021945-002	MAKENA PRESERVATIVE FREE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	RLD, RS	2016-02-19	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021945-004	MAKENA (AUTOINJECTOR)	275MG/1.1ML (250MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2018-02-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021945-001	MAKENA	1250MG/5ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP1	RLD, RS	2011-02-03	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021945-002	MAKENA PRESERVATIVE FREE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	RLD, RS	2016-02-19	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021945-004	MAKENA (AUTOINJECTOR)	275MG/1.1ML (250MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2018-02-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021945-001	MAKENA	1250MG/5ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP1	RLD, RS	2011-02-03	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021945-002	MAKENA PRESERVATIVE FREE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	RLD, RS	2016-02-19	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021945-004	MAKENA (AUTOINJECTOR)	275MG/1.1ML (250MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2018-02-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021945-001	MAKENA	1250MG/5ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP1	RLD, RS	2011-02-03	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021945-002	MAKENA PRESERVATIVE FREE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	RLD, RS	2016-02-19	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021945-004	MAKENA (AUTOINJECTOR)	275MG/1.1ML (250MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2018-02-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021945-001	MAKENA	1250MG/5ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP1	RLD, RS	2011-02-03	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021945-002	MAKENA PRESERVATIVE FREE	250MG/ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP	RLD, RS	2016-02-19	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021945-004	MAKENA (AUTOINJECTOR)	275MG/1.1ML (250MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2018-02-14	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N021945-001	MAKENA	1250MG/5ML (250MG/ML)	SOLUTION / INTRAMUSCULAR	AP1	RLD, RS	2011-02-03	`3bdfa0b2c4d7…`

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	N021945-001	AP1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021945-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021945-001	AP1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021945-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021945-001	AP1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021945-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021945-001	AP1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021945-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021945-001	AP1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021945-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021945-001	AP1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021945-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021945-001	AP1	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021945-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021945-001	AP1	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021945-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021945-001	AP1	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021945-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021945-001	AP1	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021945-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021945-001	AP1	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021945-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021945-001	AP1	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021945-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021945-001	AP1	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021945-002	AP	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N021945-001	AP1	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021945-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021945-001	AP1	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021945-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021945-001	AP1	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021945-002	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021945-001	AP1	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N021945-002	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021945-001	AP1	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021945-002	AP	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 165 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021945-004	8562564	2026-01-24		Drug product	2018-03-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021945-004	9180259	2026-01-24		Drug product	2018-03-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021945-004	9533102	2026-01-24		Drug product	2018-03-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021945-004	9629959	2026-01-24		Drug product	2018-03-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021945-004	8021335	2026-10-04		Drug product	2018-03-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021945-004	9789257	2034-02-11		Drug product	2018-03-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021945-004	10471075	2036-05-02	U-2236		2019-11-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021945-004	11154562	2036-05-02	U-2236		2021-11-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021945-004	11304962	2036-05-02	U-2236		2022-05-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021945-004	9844558	2036-05-02	U-2236		2018-03-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021945-004	8562564	2026-01-24		Drug product	2018-03-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021945-004	9180259	2026-01-24		Drug product	2018-03-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021945-004	9533102	2026-01-24		Drug product	2018-03-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021945-004	9629959	2026-01-24		Drug product	2018-03-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021945-004	8021335	2026-10-04		Drug product	2018-03-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021945-004	9789257	2034-02-11		Drug product	2018-03-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021945-004	10471075	2036-05-02	U-2236		2019-11-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021945-004	11154562	2036-05-02	U-2236		2021-11-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021945-004	9844558	2036-05-02	U-2236		2018-03-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021945-004	8562564	2026-01-24		Drug product	2018-03-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021945-004	9180259	2026-01-24		Drug product	2018-03-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021945-004	9533102	2026-01-24		Drug product	2018-03-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021945-004	9629959	2026-01-24		Drug product	2018-03-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021945-004	8021335	2026-10-04		Drug product	2018-03-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021945-004	9789257	2034-02-11		Drug product	2018-03-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021945-004	10471075	2036-05-02	U-2236		2019-11-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021945-004	11154562	2036-05-02	U-2236		2021-11-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021945-004	9844558	2036-05-02	U-2236		2018-03-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021945-004	RE44846	2019-08-10		Drug product	2018-03-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021945-004	8562564	2026-01-24		Drug product	2018-03-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021945-004	9180259	2026-01-24		Drug product	2018-03-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021945-004	9533102	2026-01-24		Drug product	2018-03-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021945-004	9629959	2026-01-24		Drug product	2018-03-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021945-004	8021335	2026-10-04		Drug product	2018-03-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021945-004	9789257	2034-02-11		Drug product	2018-03-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021945-004	9844558	2036-05-02	U-2236		2018-03-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021945-004	8562564	2026-01-24		Drug product	2018-03-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021945-004	9180259	2026-01-24		Drug product	2018-03-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021945-004	9533102	2026-01-24		Drug product	2018-03-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021945-004	9629959	2026-01-24		Drug product	2018-03-02	`bb7c543d1eb4…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64011-247-02	ML - Milliliter	64011-247	f5cc6d0c-4037-49d1-aa6b-948cce066496	1	2016-04-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROXYPROGESTERONE CAPROATE	ACTIVE INGREDIENT	276F2O42F5	MAKENA (HYDROXYPROGESTERONE CAPROATE) INJECTION [LUMARA HEALTH INC.]	8
HYDROXYPROGESTERONE	ACTIVE MOIETY	21807M87J2	MAKENA (HYDROXYPROGESTERONE CAPROATE) INJECTION [LUMARA HEALTH INC.]	8
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	MAKENA (HYDROXYPROGESTERONE CAPROATE) INJECTION [LUMARA HEALTH INC.]	8
BENZYL BENZOATE	INACTIVE INGREDIENT	N863NB338G	MAKENA (HYDROXYPROGESTERONE CAPROATE) INJECTION [LUMARA HEALTH INC.]	8
CASTOR OIL	INACTIVE INGREDIENT	D5340Y2I9G	MAKENA (HYDROXYPROGESTERONE CAPROATE) INJECTION [LUMARA HEALTH INC.]	8

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64011-247-02	64011024702	4 CARTON in 1 TRAY (64011-247-02) > 1 VIAL, GLASS in 1 CARTON > 1 mL in 1 VIAL, GLASS	4 carton	2011-02-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Makena	AMAG Pharmaceuticals, Inc. \| Piramal Pharma Solutions Inc. \| Pharmacia and Upjohn Company LLC \| Fresenius Kabi Austria	2022-12-19	HUMAN PRESCRIPTION DRUG LABEL	16