Norethindrone Acetate

Product NDC: 68462-304
11-digit product format: 684620304
Labeler code: 68462
Product ID: 68462-304_61f08f82-c9ec-45cf-ab8b-18afabde75e2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Norethindrone Acetate
Dosage form: TABLET
Route: ORAL
Labeler: Glenmark Pharmaceuticals Inc., USA
Application: ANDA091090
Marketing category: ANDA
Marketing start: 2010-07-21
Substance: NORETHINDRONE ACETATE
Active strength: 5 mg/1
Pharmacologic classes: Progesterone Congeners [CS], Progestin [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
A091090-001	NORETHINDRONE ACETATE	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB		2010-07-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091090-001	AB

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	A091090-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2010-07-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091090-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2010-07-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091090-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2010-07-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091090-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2010-07-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091090-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2010-07-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091090-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2010-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091090-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2010-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091090-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2010-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091090-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2010-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091090-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2010-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091090-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2010-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091090-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2010-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091090-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2010-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091090-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2010-07-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091090-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2010-07-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091090-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2010-07-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091090-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2010-07-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091090-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2010-07-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091090-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2010-07-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091090-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2010-07-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091090-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2010-07-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091090-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2010-07-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091090-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2010-07-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091090-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2010-07-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091090-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2010-07-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091090-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2010-07-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091090-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2010-07-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091090-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2010-07-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091090-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2010-07-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091090-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2010-07-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091090-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2010-07-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091090-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2010-07-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091090-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2010-07-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091090-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2010-07-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091090-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2010-07-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091090-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2010-07-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091090-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2010-07-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091090-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2010-07-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091090-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2010-07-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091090-001	NORETHINDRONE ACETATE	5MG	TABLET / ORAL	AB	2010-07-21	`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	A091090-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091090-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091090-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091090-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091090-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091090-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091090-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091090-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091090-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091090-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091090-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091090-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091090-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091090-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091090-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091090-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091090-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091090-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091090-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091090-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091090-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091090-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091090-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091090-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091090-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091090-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091090-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091090-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091090-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091090-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091090-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091090-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091090-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091090-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091090-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091090-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091090-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091090-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091090-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091090-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Norethindrone Acetate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NORETHINDRONE ACETATE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9S44LIC7OJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1000405	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
d0a94321-eb60-4aa6-a429-f0156f9f8e01	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
68462-304-05	Norethindrone Acetate	500 in 1 BOTTLE	TABLET	500		10
68462-304-50	Norethindrone Acetate	50 in 1 BOTTLE	TABLET	50		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-304-50	EA - Each	68462-304	782884ed-bb6d-48b8-8da3-552e7bd53830	1	2012-07-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-304	NORETHINDRONE ACETATE TABLET [GLENMARK PHARMACEUTICALS INC., USA]	9	Current NDC, Legacy NDC, 2 package rows	20240104_d0a94321-eb60-4aa6-a429-f0156f9f8e01.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Norethindrone Acetate	NORETHINDRONE ACETATE	Glenmark Pharmaceuticals Inc., USA	d0a94321-eb60-4aa6-a429-f0156f9f8e01	2026-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091090 application number: ANDA091090 ndc (product): 68462-304
Norethindrone Acetate	NORETHINDRONE ACETATE	American Health Packaging	eb0b80e0-5b69-4efa-ae8a-62e718a62dc3	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091090 application number: ANDA091090

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9S44LIC7OJ	NORETHINDRONE ACETATE	51-98-9	NORETHINDRONE ACETATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1000405	norethindrone acetate 5 MG Oral Tablet	PSN	d0a94321-eb60-4aa6-a429-f0156f9f8e01	10
1000405	norethindrone acetate 5 MG Oral Tablet	SCD	d0a94321-eb60-4aa6-a429-f0156f9f8e01	10
1000405	norethindrone acetate 5 MG Oral Tablet	PSN	eb0b80e0-5b69-4efa-ae8a-62e718a62dc3	2
1000405	norethindrone acetate 5 MG Oral Tablet	SCD	eb0b80e0-5b69-4efa-ae8a-62e718a62dc3	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-304-05	68462030405	500 TABLET in 1 BOTTLE (68462-304-05)	500 tablet	2010-07-21	0000-00-00	No	No	Current
68462-304-50	68462030450	50 TABLET in 1 BOTTLE (68462-304-50)	50 tablet	2010-07-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Norethindrone Acetate Tablets USP, 5 mg	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited	2026-01-29	HUMAN PRESCRIPTION DRUG LABEL	10
Norethindrone Acetate Tablets USP Rx Only 8492121/0625F	American Health Packaging	2026-01-14	HUMAN PRESCRIPTION DRUG LABEL	2
Norethindrone Acetate Tablets USP, 5 mg	KAISER FOUNDATION HOSPITALS	2018-11-21	HUMAN PRESCRIPTION DRUG LABEL	2