Lupaneta Pack

Product NDC: 0074-1053
11-digit product format: 000741053
Labeler code: 0074
Product ID: 0074-1053_303366b1-a979-4be1-9f40-1331e9d71b3d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: leuprolide acetate and norethindrone acetate
Dosage form: KIT
Labeler: AbbVie Inc.
Application: NDA203696
Marketing category: NDA
Marketing start: 2013-07-01
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2022-12-31
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	0074-1053		D	Discontinued by firm		2026-08-03
excluded package	package	0074-1053	0074-1053-05	D	Discontinued by firm		2026-08-03

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	0074-1053-05	`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	0074-1053-05	`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	0074-1053-05	`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	0074-1053-05	`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	0074-1053-05	`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	0074-1053-05	`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	0074-1053-05	`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	0074-1053-05	`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	0074-1053-05	`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	0074-1053-05	`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	0074-1053-05	`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	0074-1053-05	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N203696-001	LUPANETA PACK	LEUPROLIDE ACETATE; NORETHINDRONE ACETATE	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL		RLD	2012-12-14
N203696-002	LUPANETA PACK	LEUPROLIDE ACETATE; NORETHINDRONE ACETATE	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL		RLD	2012-12-14

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N203696-001	LUPANETA PACK	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203696-002	LUPANETA PACK	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203696-001	LUPANETA PACK	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203696-002	LUPANETA PACK	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203696-001	LUPANETA PACK	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203696-002	LUPANETA PACK	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203696-001	LUPANETA PACK	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203696-002	LUPANETA PACK	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203696-001	LUPANETA PACK	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203696-002	LUPANETA PACK	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203696-001	LUPANETA PACK	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203696-002	LUPANETA PACK	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203696-001	LUPANETA PACK	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203696-002	LUPANETA PACK	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203696-001	LUPANETA PACK	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203696-002	LUPANETA PACK	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203696-001	LUPANETA PACK	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203696-002	LUPANETA PACK	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203696-001	LUPANETA PACK	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203696-002	LUPANETA PACK	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203696-001	LUPANETA PACK	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203696-002	LUPANETA PACK	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203696-001	LUPANETA PACK	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203696-002	LUPANETA PACK	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203696-001	LUPANETA PACK	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203696-002	LUPANETA PACK	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203696-001	LUPANETA PACK	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N203696-002	LUPANETA PACK	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203696-001	LUPANETA PACK	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203696-002	LUPANETA PACK	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203696-001	LUPANETA PACK	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203696-002	LUPANETA PACK	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203696-001	LUPANETA PACK	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203696-002	LUPANETA PACK	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203696-001	LUPANETA PACK	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203696-002	LUPANETA PACK	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD, RS	2012-12-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203696-001	LUPANETA PACK	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N203696-002	LUPANETA PACK	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203696-001	LUPANETA PACK	3.75MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N203696-002	LUPANETA PACK	11.25MG/VIAL,N/A;N/A,5MG	INJECTABLE, TABLET / INTRAMUSCULAR, ORAL	RLD	2012-12-14	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0074-1053-05	EA - Each	0074-1053	2ffa6038-5562-4704-a350-13bd5f3fd67c	1	2014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ISOPROPYL ALCOHOL	ACTIVE INGREDIENT	ND2M416302	LUPANETA PACK (LEUPROLIDE ACETATE AND NORETHINDRONE ACETATE) KIT [ABBVIE INC.]	76
LEUPROLIDE ACETATE	ACTIVE INGREDIENT	37JNS02E7V	LUPANETA PACK (LEUPROLIDE ACETATE AND NORETHINDRONE ACETATE) KIT [ABBVIE INC.]	76
NORETHINDRONE ACETATE	ACTIVE INGREDIENT	9S44LIC7OJ	LUPANETA PACK (LEUPROLIDE ACETATE AND NORETHINDRONE ACETATE) KIT [ABBVIE INC.]	76
ISOPROPYL ALCOHOL	ACTIVE MOIETY	ND2M416302	LUPANETA PACK (LEUPROLIDE ACETATE AND NORETHINDRONE ACETATE) KIT [ABBVIE INC.]	76
LEUPROLIDE	ACTIVE MOIETY	EFY6W0M8TG	LUPANETA PACK (LEUPROLIDE ACETATE AND NORETHINDRONE ACETATE) KIT [ABBVIE INC.]	76
NORETHINDRONE	ACTIVE MOIETY	T18F433X4S	LUPANETA PACK (LEUPROLIDE ACETATE AND NORETHINDRONE ACETATE) KIT [ABBVIE INC.]	76
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	LUPANETA PACK (LEUPROLIDE ACETATE AND NORETHINDRONE ACETATE) KIT [ABBVIE INC.]	76
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	INACTIVE INGREDIENT	K679OBS311	LUPANETA PACK (LEUPROLIDE ACETATE AND NORETHINDRONE ACETATE) KIT [ABBVIE INC.]	76
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LUPANETA PACK (LEUPROLIDE ACETATE AND NORETHINDRONE ACETATE) KIT [ABBVIE INC.]	76
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LUPANETA PACK (LEUPROLIDE ACETATE AND NORETHINDRONE ACETATE) KIT [ABBVIE INC.]	76
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LUPANETA PACK (LEUPROLIDE ACETATE AND NORETHINDRONE ACETATE) KIT [ABBVIE INC.]	76
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	LUPANETA PACK (LEUPROLIDE ACETATE AND NORETHINDRONE ACETATE) KIT [ABBVIE INC.]	76
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	LUPANETA PACK (LEUPROLIDE ACETATE AND NORETHINDRONE ACETATE) KIT [ABBVIE INC.]	76
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LUPANETA PACK (LEUPROLIDE ACETATE AND NORETHINDRONE ACETATE) KIT [ABBVIE INC.]	76
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LUPANETA PACK (LEUPROLIDE ACETATE AND NORETHINDRONE ACETATE) KIT [ABBVIE INC.]	76
WATER	INACTIVE INGREDIENT	059QF0KO0R	LUPANETA PACK (LEUPROLIDE ACETATE AND NORETHINDRONE ACETATE) KIT [ABBVIE INC.]	76

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0074-1053-05	00074105305	1 KIT in 1 CARTON (0074-1053-05) * 90 TABLET in 1 BOTTLE * 1 mL in 1 PACKET * 1.5 mL in 1 SYRINGE	1 kit	2013-07-01	0000-00-00	No	No	Current