Nora BE

Product NDC: 0480-3475
11-digit product format: 004803475
Labeler code: 0480
Product ID: 0480-3475_78fd3447-1830-42be-9ebf-7555ad7ec5b6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Norethindrone
Dosage form: TABLET
Route: ORAL
Labeler: Teva Pharmaceuticals, Inc.
Application: NDA017060
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2023-12-01
Substance: NORETHINDRONE
Active strength: .35 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 44.

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
N017060-001	NOR-QD	NORETHINDRONE	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N017060-001	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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-10-15 13:18:30	2026-09	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017060-001	NOR-QD	0.35MG	TABLET / ORAL-28	AB1	RLD, RS, Approved before 1982	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N017060-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017060-001	AB1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017060-001	AB1	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017060-001	AB1	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Nora BE
Listing expiration: 2027-12-31

Active Ingredients#

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

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
0480-3475-16	Nora BE	6 in 1 CARTON	TABLET	6		3
0480-3475-16	Nora BE	28 in 1 PACKAGE	TABLET	28		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0480-3475-16	EA - Each	0480-3475	657fffa1-65b0-4796-b627-ff2470582959	1	2024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0480-3475	NORA BE (NORETHINDRONE) TABLET [TEVA PHARMACEUTICALS, INC.]	3	Current NDC, 2 package rows	20241102_426ac898-7745-4645-bf9b-bae319e260e8.zip

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
748977	{28 (norethindrone 0.35 MG Oral Tablet) } Pack [Nora-BE 28 Day]	BPCK	426ac898-7745-4645-bf9b-bae319e260e8	3
748961	{28 (norethindrone 0.35 MG Oral Tablet) } Pack	GPCK	426ac898-7745-4645-bf9b-bae319e260e8	3
748977	Nora-BE 28 Day Pack	PSN	426ac898-7745-4645-bf9b-bae319e260e8	3
748961	Noreth 0.35 MG (28) Oral Tablet 28 Day Pack	PSN	426ac898-7745-4645-bf9b-bae319e260e8	3
198042	norethindrone 0.35 MG Oral Tablet	PSN	426ac898-7745-4645-bf9b-bae319e260e8	3
198042	norethindrone 0.35 MG Oral Tablet	SCD	426ac898-7745-4645-bf9b-bae319e260e8	3
748977	Nora-BE 28 Day Pack	SY	426ac898-7745-4645-bf9b-bae319e260e8	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0480-3475-16	00480347516	6 PACKAGE in 1 CARTON (0480-3475-16) / 28 TABLET in 1 PACKAGE	6 package	2023-12-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nora-BE ® (Norethindrone 0.35 mg tablets USP)	Teva Pharmaceuticals, Inc.	2024-04-02	HUMAN PRESCRIPTION DRUG LABEL	3