NORETHINDRONE

Product NDC: 68180-876
Requested package NDC: 68180-876-13
11-digit product format: 681800876
Labeler code: 68180
Product ID: 68180-876_21d08d75-2957-4610-94c1-76c844ba2f1b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: NORETHINDRONE
Dosage form: TABLET
Route: ORAL
Labeler: Lupin Pharmaceuticals, Inc.
Application: ANDA091325
Marketing category: ANDA
Marketing start: 2020-11-11
Substance: NORETHINDRONE
Active strength: .35 mg/1
Pharmacologic classes: Progesterone Congeners [CS], Progestin [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68180-876	68180-876-13	D	Discontinued by firm		2026-08-11

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091325-001	NORETHINDRONE	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1		2011-09-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A091325-001	AB1

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 · 41 observed 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
2026-02-19 14:30 UTC	2026-02	A091325-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2011-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091325-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2011-09-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091325-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2011-09-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091325-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2011-09-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091325-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2011-09-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091325-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2011-09-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091325-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2011-09-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091325-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2011-09-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091325-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2011-09-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091325-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2011-09-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091325-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2011-09-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091325-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2011-09-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091325-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2011-09-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091325-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2011-09-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091325-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2011-09-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091325-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2011-09-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091325-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2011-09-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091325-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2011-09-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091325-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2011-09-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091325-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2011-09-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091325-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2011-09-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091325-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2011-09-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091325-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2011-09-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091325-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2011-09-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091325-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2011-09-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091325-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2011-09-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091325-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2011-09-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091325-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2011-09-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091325-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2011-09-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091325-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2011-09-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091325-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2011-09-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091325-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2011-09-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091325-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2011-09-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091325-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2011-09-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091325-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2011-09-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091325-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2011-09-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091325-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2011-09-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091325-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2011-09-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091325-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2011-09-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091325-001	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	2011-09-19	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091325-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091325-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091325-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091325-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091325-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091325-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091325-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091325-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091325-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091325-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091325-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091325-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091325-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091325-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091325-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091325-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091325-001	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091325-001	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091325-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091325-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091325-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091325-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091325-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091325-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091325-001	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091325-001	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091325-001	AB1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091325-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091325-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091325-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091325-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091325-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091325-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091325-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091325-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091325-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091325-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091325-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091325-001	AB1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091325-001	AB1	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: NORETHINDRONE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NORETHINDRONE	.35 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
T18F433X4S	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198042	Internal RxNorm lookup
748961	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
121fbf86-1d76-4579-be2f-be9a957b23ab	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d39a542a-f5b0-4c2d-a820-0f5d39e6621f	Product name	1	20250307
859c4b0b-8cba-4f41-9afe-cc181a01fb62	Product name	2	20240215
0d9f32e2-f85b-4d63-9f04-b06059c34749	Product name	3	20230323
833edb59-a012-45c2-aff5-2ed74b66fa59	Product name	1	20201207
cec4644c-0fed-4608-a5ea-d3a1b1b6d697	Product name	2	20200728
00a01e22-7ea3-6f8f-0cc1-380aac10f424	Product name	6	20200716
f4d31098-441e-52d3-27f1-49c829f8a3a1	Product name	5	20190703
c21bcd2e-ecbd-48e6-ab68-12cc12256c0f	Product name	2	20190213
c6636356-4ccb-40e9-a952-59eb1f2fc859	Product name	4	20180806
e042bc86-5d40-8945-82f8-de9dd95420dd	Product name	6	20180606
390e6d23-3a11-4327-9294-c958a378baae	Product name	4	20180124
b651f154-0364-4007-9dc6-9d33036db1d7	Product name	4	20170808
3395ac9b-f30b-4991-80ba-fd5196be0214	Product name	3	20170802
a5e2d962-d98c-4fbf-8183-ffd42dd01e19	Product name	6	20170711
00606b81-6e33-4c38-9ca9-bd14bd74d84c	Product name	4	20170501
f4ce24e8-8632-4fad-9984-b693f985f80f	Product name	3	20170501
b17c5419-b38b-579f-10bc-8a4ce69fc044	Product name	5	20170316
f6ac5560-6d3b-d281-41d2-adc50d283c20	Product name	3	20170228
01996782-abcb-4e6d-bcaf-4a23e6a95c0c	Product name	1	20160714
2aecf0b6-88a0-49e5-92e1-983c700c116c	Product name	1	20151222
61972742-5d4d-491d-a881-b6bc3a011577	Product name	1	20151113
23ede539-308f-46e5-817b-41ef23af8d40	Product name	1	20150930
425e3610-bbe8-4d70-9c46-8cf09afc4e4d	Product name	1	20150930
5e13e814-349e-3480-99f3-ee22a591426f	Product name	2	20150518
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68180-876-73	NORETHINDRONE	28 in 1 BLISTER PACK	TABLET	28		5
68180-876-73	NORETHINDRONE	3 in 1 CARTON	TABLET	3		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68180-876-11	EA - Each	68180-876	48bbc9ef-a39b-4026-8d14-2d679bd498fe	1	2012-07-24
68180-876-13	EA - Each	68180-876	858234e4-0c1f-4e3c-9ca9-8c77ea871049	1	2012-07-24
68180-876-71	EA - Each	68180-876	618f4a6c-e98e-4d4c-b890-21b068a35c79	1	2021-05-05
68180-876-73	EA - Each	68180-876	ae51c471-36c3-4ba3-a048-08495240fc9d	1	2021-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NORETHINDRONE	ACTIVE INGREDIENT	T18F433X4S	NORETHINDRONE TABLET [LUPIN PHARMACEUTICALS, INC.]	6
NORETHINDRONE	ACTIVE MOIETY	T18F433X4S	NORETHINDRONE TABLET [LUPIN PHARMACEUTICALS, INC.]	6
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	NORETHINDRONE TABLET [LUPIN PHARMACEUTICALS, INC.]	6
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	NORETHINDRONE TABLET [LUPIN PHARMACEUTICALS, INC.]	6
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NORETHINDRONE TABLET [LUPIN PHARMACEUTICALS, INC.]	6
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	NORETHINDRONE TABLET [LUPIN PHARMACEUTICALS, INC.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NORETHINDRONE TABLET [LUPIN PHARMACEUTICALS, INC.]	6
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	NORETHINDRONE TABLET [LUPIN PHARMACEUTICALS, INC.]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NORETHINDRONE TABLET [LUPIN PHARMACEUTICALS, INC.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68180-876	NORETHINDRONE TABLET [LUPIN PHARMACEUTICALS, INC.]	5	Current NDC, Legacy NDC, 2 package rows	20250227_121fbf86-1d76-4579-be2f-be9a957b23ab.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NORETHINDRONE	NORETHINDRONE	Proficient Rx LP	bbd54f1e-2d48-4efa-a57e-7fa7b478c457	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091325 application number: ANDA091325
NORETHINDRONE	NORETHINDRONE	Lupin Pharmaceuticals, Inc.	121fbf86-1d76-4579-be2f-be9a957b23ab	2025-02-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091325 application number: ANDA091325 ndc (product): 68180-876
NORETHINDRONE	NORETHINDRONE	A-S Medication Solutions	70231aa1-9dd2-420f-9cb3-432d3c2477d1	2025-02-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091325 application number: ANDA091325

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
T18F433X4S	NORETHINDRONE	68-22-4	NORETHINDRONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
748961	{28 (norethindrone 0.35 MG Oral Tablet) } Pack	GPCK	70231aa1-9dd2-420f-9cb3-432d3c2477d1	7
748961	Noreth 0.35 MG (28) Oral Tablet 28 Day Pack	PSN	70231aa1-9dd2-420f-9cb3-432d3c2477d1	7
198042	norethindrone 0.35 MG Oral Tablet	PSN	70231aa1-9dd2-420f-9cb3-432d3c2477d1	7
198042	norethindrone 0.35 MG Oral Tablet	SCD	70231aa1-9dd2-420f-9cb3-432d3c2477d1	7
748961	{28 (norethindrone 0.35 MG Oral Tablet) } Pack	GPCK	121fbf86-1d76-4579-be2f-be9a957b23ab	5
748961	Noreth 0.35 MG (28) Oral Tablet 28 Day Pack	PSN	121fbf86-1d76-4579-be2f-be9a957b23ab	5
198042	norethindrone 0.35 MG Oral Tablet	PSN	121fbf86-1d76-4579-be2f-be9a957b23ab	5
198042	norethindrone 0.35 MG Oral Tablet	SCD	121fbf86-1d76-4579-be2f-be9a957b23ab	5
748961	{28 (norethindrone 0.35 MG Oral Tablet) } Pack	GPCK	bbd54f1e-2d48-4efa-a57e-7fa7b478c457	1
748961	Noreth 0.35 MG (28) Oral Tablet 28 Day Pack	PSN	bbd54f1e-2d48-4efa-a57e-7fa7b478c457	1
198042	norethindrone 0.35 MG Oral Tablet	PSN	bbd54f1e-2d48-4efa-a57e-7fa7b478c457	1
198042	norethindrone 0.35 MG Oral Tablet	SCD	bbd54f1e-2d48-4efa-a57e-7fa7b478c457	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68180-876-13	68180087613	3 BLISTER PACK in 1 CARTON (68180-876-13) > 28 TABLET in 1 BLISTER PACK (68180-876-11)	3 blister pack	2011-11-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Norethindrone Tablets USP	Proficient Rx LP	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	1
Norethindrone Tablets USP	Lupin Pharmaceuticals, Inc. \| LUPIN LIMITED	2025-02-25	HUMAN PRESCRIPTION DRUG LABEL	5
Norethindrone Tablets USP	A-S Medication Solutions	2025-02-18	HUMAN PRESCRIPTION DRUG LABEL	7
Norethindrone Tablets USP	Lupin Pharmaceuticals, Inc. \| LUPIN LIMITED	2023-12-13	HUMAN PRESCRIPTION DRUG LABEL	9