National Council for Prescription Drug Programs indexing - billing unit

Manufacturer: National Council for Prescription Drug Programs
Effective date: 2012-07-24
Label type: Indexing - Billing Unit
Version: 1
Source: full-release
Hydrated at: 2026-06-05 01:00:33

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64011-243-01	ML - Milliliter	64011-243	03c20a4e-36e2-494a-922f-298903bd3074	1	2012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
64011-243	64011-243-01

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.