OSHIH

Product NDC: 59651-504
Requested package NDC: 59651-504-88
11-digit product format: 596510504
Labeler code: 59651
Product ID: 59651-504_3bf10185-1849-49a1-9b3b-ba35a0413408
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: norethindrone acetate and ethinyl estradiol and ferrous fumarate
Dosage form: KIT
Labeler: Aurobindo Pharma Limited
Application: ANDA216558
Marketing category: ANDA
Marketing start: 2023-12-06
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A216558-001	OSHIH	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	TABLET / ORAL			2023-12-06

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A216558-001	OSHIH	0.02MG;1MG	TABLET / ORAL		2023-12-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216558-001	OSHIH	0.02MG;1MG	TABLET / ORAL		2023-12-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216558-001	OSHIH	0.02MG;1MG	TABLET / ORAL		2023-12-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216558-001	OSHIH	0.02MG;1MG	TABLET / ORAL		2023-12-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216558-001	OSHIH	0.02MG;1MG	TABLET / ORAL		2023-12-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216558-001	OSHIH	0.02MG;1MG	TABLET / ORAL		2023-12-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216558-001	OSHIH	0.02MG;1MG	TABLET / ORAL		2023-12-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216558-001	OSHIH	0.02MG;1MG	TABLET / ORAL		2023-12-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216558-001	OSHIH	0.02MG;1MG	TABLET / ORAL		2023-12-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216558-001	OSHIH	0.02MG;1MG	TABLET / ORAL		2023-12-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216558-001	OSHIH	0.02MG;1MG	TABLET / ORAL		2023-12-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216558-001	OSHIH	0.02MG;1MG	TABLET / ORAL		2023-12-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216558-001	OSHIH	0.02MG;1MG	TABLET / ORAL		2023-12-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216558-001	OSHIH	0.02MG;1MG	TABLET / ORAL		2023-12-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216558-001	OSHIH	0.02MG;1MG	TABLET / ORAL		2023-12-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216558-001	OSHIH	0.02MG;1MG	TABLET / ORAL	AB	2023-12-06	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216558-001	OSHIH	0.02MG;1MG	TABLET / ORAL	AB	2023-12-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216558-001	OSHIH	0.02MG;1MG	TABLET / ORAL	AB	2023-12-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216558-001	OSHIH	0.02MG;1MG	TABLET / ORAL	AB	2023-12-06	`ea1830bbd6c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216558-001	OSHIH	0.02MG;1MG	TABLET / ORAL		2023-12-06	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-05-31 18:47 UTC	2024-05	A216558-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216558-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216558-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216558-001	AB	1	`ea1830bbd6c7…`

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: OSHIH
Listing expiration: 2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
259176	Internal RxNorm lookup
1426288	Internal RxNorm lookup
1426600	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
7c07e339-3aae-4c77-a170-e6715bbe7563	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d1ecea64-06d1-4fdc-a2a1-b801e0cd0d11	Product name	4	20250623
d39a542a-f5b0-4c2d-a820-0f5d39e6621f	Product name	1	20250307
8511fc19-172b-4e1f-90ec-2f09c85b16de	Product name	2	20250116
d9a998ac-31a9-4391-9054-c30e50912603	Product name	2	20240829
782f1593-b73e-4d35-8017-647969d714d8	Product name	4	20240805
859c4b0b-8cba-4f41-9afe-cc181a01fb62	Product name	2	20240215
1a545a57-aed5-4b6e-b1f9-a93c26d50eff	Product name	1	20230829
a0f93f28-4e91-4bb1-8dcb-5456fd4bfc50	Product name	3	20230718
a057e1a7-94b1-4663-8d17-a3bbf3a12689	Product name	5	20230627
0d9f32e2-f85b-4d63-9f04-b06059c34749	Product name	3	20230323
fa479cfe-0bd0-7366-d57a-92f3682e87c5	Product name	3	20210518
20e1a411-dba8-4afa-b9f9-1205d5b0bde9	Product name	3	20210513
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
5956a0e2-c373-452c-bdcf-c93d354432ef	Product name	1	20200714
ca306105-d51c-4821-9ec1-8eec753d073d	Product name	1	20200619
f1d1b304-0b6c-25e9-a872-86d3d4bd2ab9	Product name	8	20200612
0381745d-0d4c-bcc1-87eb-abb98c1e6cb6	Product name	8	20191120
f4d31098-441e-52d3-27f1-49c829f8a3a1	Product name	5	20190703
6dd982ab-2966-22ee-3b75-d225abb791aa	Product name	5	20190612
d2c4820a-bb24-f61d-8cd0-dd0290a6bd4d	Product name	7	20190612
f92411e4-13dd-7baf-106e-9b3fcf758c39	Product name	4	20190502
c21bcd2e-ecbd-48e6-ab68-12cc12256c0f	Product name	2	20190213
60ff9adc-7870-42ca-8836-514bd9732fa8	Product name	4	20181220
ddff2484-d547-4e6a-bacd-95eef7e31c64	Product name	2	20180807
c6636356-4ccb-40e9-a952-59eb1f2fc859	Product name	4	20180806
79d5025d-8129-440a-b861-6df2d2661609	Product name	3	20180607
e042bc86-5d40-8945-82f8-de9dd95420dd	Product name	6	20180606
d871c48c-6b0b-4203-b55d-72ead21ea7ad	Product name	5	20180419
90854981-3820-4bc4-a1d3-666ec508941c	Product name	2	20180214
390e6d23-3a11-4327-9294-c958a378baae	Product name	4	20180124
12434b90-2738-45d5-9e1b-55001e853273	Product name	2	20171122
b651f154-0364-4007-9dc6-9d33036db1d7	Product name	4	20170808
3395ac9b-f30b-4991-80ba-fd5196be0214	Product name	3	20170802
2d386545-84d1-e1e9-1402-7fc8962353e8	Product name	2	20170717
a5e2d962-d98c-4fbf-8183-ffd42dd01e19	Product name	6	20170711
30783b73-16b0-4cc1-b03a-e5d801c0d7a8	Product name	4	20170608
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
120cc5ad-761c-444c-9e82-dec22f96dfe1	Product name	7	20161219
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
d0cc7d42-77a7-b452-c6c3-a162fa11225f	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59651-504-88	OSHIH	3 in 1 CARTON	KIT	3		2
59651-504-88	OSHIH	1 in 1 POUCH	KIT	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59651-504	OSHIH (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [AUROBINDO PHARMA LIMITED]	2	Current NDC, 2 package rows	20240216_7c07e339-3aae-4c77-a170-e6715bbe7563.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OSHIH	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	Aurobindo Pharma Limited	7c07e339-3aae-4c77-a170-e6715bbe7563	2024-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216558 application number: ANDA216558 ndc (package): 59651-504-88 ndc (product): 59651-504 ndc11 (package): 59651050488

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1426600	{24 (ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Chewable Tablet) / 4 (ferrous fumarate 75 MG Oral Tablet) } Pack	GPCK	7c07e339-3aae-4c77-a170-e6715bbe7563	2
1426600	Eth estra-Noreth Ac 0.02-1 MG (24) Chewable Tablet / Ferr fum 75 MG (4) Oral Tablet 28 Day Pack	PSN	7c07e339-3aae-4c77-a170-e6715bbe7563	2
259176	ferrous fumarate 75 MG Oral Tablet	PSN	7c07e339-3aae-4c77-a170-e6715bbe7563	2
1426288	norethindrone acetate 1 MG / ethinyl estradiol 20 MCG Chewable Tablet	PSN	7c07e339-3aae-4c77-a170-e6715bbe7563	2
1426288	ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Chewable Tablet	SCD	7c07e339-3aae-4c77-a170-e6715bbe7563	2
259176	ferrous fumarate 75 MG Oral Tablet	SCD	7c07e339-3aae-4c77-a170-e6715bbe7563	2
1426288	ethinyl estradiol 20 MCG / norethindrone acetate 1 MG Chewable Tablet	SY	7c07e339-3aae-4c77-a170-e6715bbe7563	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
59651-504-88	59651050488	3 POUCH in 1 CARTON (59651-504-88) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK	3 pouch	2023-12-06	No	No	Current