OCELLA

Product NDC: 0555-9131
Requested package NDC: 0555-9131-67
11-digit product format: 005559131
Labeler code: 0555
Product ID: 0555-9131_7aced6b3-f763-4234-9b64-2ffdae162347
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: drospirenone and ethinyl estradiol
Dosage form: KIT
Labeler: TEVA PHARMACEUTICALS USA, INC.
Application: NDA021098
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2001-06-11
Marketing end: 2026-06-30
NDC exclude flag: No
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	0555-9131	0555-9131-67	D	Discontinued by firm		2026-08-11

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
N021098-001	YASMIN	DROSPIRENONE; ETHINYL ESTRADIOL	3MG;0.03MG	TABLET / ORAL-28	AB	RLD, RS	2001-05-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021098-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021098-001	YASMIN	3MG;0.03MG	TABLET / ORAL-28	AB	RLD, RS	2001-05-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021098-001	YASMIN	3MG;0.03MG	TABLET / ORAL-28	AB	RLD, RS	2001-05-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021098-001	YASMIN	3MG;0.03MG	TABLET / ORAL-28	AB	RLD, RS	2001-05-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021098-001	YASMIN	3MG;0.03MG	TABLET / ORAL-28	AB	RLD, RS	2001-05-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021098-001	YASMIN	3MG;0.03MG	TABLET / ORAL-28	AB	RLD, RS	2001-05-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021098-001	YASMIN	3MG;0.03MG	TABLET / ORAL-28	AB	RLD, RS	2001-05-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021098-001	YASMIN	3MG;0.03MG	TABLET / ORAL-28	AB	RLD, RS	2001-05-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021098-001	YASMIN	3MG;0.03MG	TABLET / ORAL-28	AB	RLD, RS	2001-05-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021098-001	YASMIN	3MG;0.03MG	TABLET / ORAL-28	AB	RLD, RS	2001-05-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021098-001	YASMIN	3MG;0.03MG	TABLET / ORAL-28	AB	RLD, RS	2001-05-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021098-001	YASMIN	3MG;0.03MG	TABLET / ORAL-28	AB	RLD, RS	2001-05-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021098-001	YASMIN	3MG;0.03MG	TABLET / ORAL-28	AB	RLD, RS	2001-05-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021098-001	YASMIN	3MG;0.03MG	TABLET / ORAL-28	AB	RLD, RS	2001-05-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021098-001	YASMIN	3MG;0.03MG	TABLET / ORAL-28	AB	RLD, RS	2001-05-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021098-001	YASMIN	3MG;0.03MG	TABLET / ORAL-28	AB	RLD, RS	2001-05-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021098-001	YASMIN	3MG;0.03MG	TABLET / ORAL-28	AB	RLD, RS	2001-05-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021098-001	YASMIN	3MG;0.03MG	TABLET / ORAL-28	AB	RLD, RS	2001-05-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021098-001	YASMIN	3MG;0.03MG	TABLET / ORAL-28	AB	RLD, RS	2001-05-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021098-001	YASMIN	3MG;0.03MG	TABLET / ORAL-28	AB	RLD, RS	2001-05-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021098-001	YASMIN	3MG;0.03MG	TABLET / ORAL-28	AB	RLD, RS	2001-05-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021098-001	YASMIN	3MG;0.03MG	TABLET / ORAL-28	AB	RLD, RS	2001-05-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021098-001	YASMIN	3MG;0.03MG	TABLET / ORAL-28	AB	RLD, RS	2001-05-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021098-001	YASMIN	3MG;0.03MG	TABLET / ORAL-28	AB	RLD, RS	2001-05-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021098-001	YASMIN	3MG;0.03MG	TABLET / ORAL-28	AB	RLD, RS	2001-05-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021098-001	YASMIN	3MG;0.03MG	TABLET / ORAL-28	AB	RLD, RS	2001-05-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021098-001	YASMIN	3MG;0.03MG	TABLET / ORAL-28	AB	RLD, RS	2001-05-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021098-001	YASMIN	3MG;0.03MG	TABLET / ORAL-28	AB	RLD, RS	2001-05-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021098-001	YASMIN	3MG;0.03MG	TABLET / ORAL-28	AB	RLD, RS	2001-05-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021098-001	YASMIN	3MG;0.03MG	TABLET / ORAL-28	AB	RLD, RS	2001-05-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021098-001	YASMIN	3MG;0.03MG	TABLET / ORAL-28	AB	RLD, RS	2001-05-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021098-001	YASMIN	3MG;0.03MG	TABLET / ORAL-28	AB	RLD, RS	2001-05-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021098-001	YASMIN	3MG;0.03MG	TABLET / ORAL-28	AB	RLD, RS	2001-05-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021098-001	YASMIN	3MG;0.03MG	TABLET / ORAL-28	AB	RLD, RS	2001-05-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021098-001	YASMIN	3MG;0.03MG	TABLET / ORAL-28	AB	RLD, RS	2001-05-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021098-001	YASMIN	3MG;0.03MG	TABLET / ORAL-28	AB	RLD, RS	2001-05-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021098-001	YASMIN	3MG;0.03MG	TABLET / ORAL-28	AB	RLD, RS	2001-05-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021098-001	YASMIN	3MG;0.03MG	TABLET / ORAL-28	AB	RLD, RS	2001-05-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021098-001	YASMIN	3MG;0.03MG	TABLET / ORAL-28	AB	RLD, RS	2001-05-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021098-001	YASMIN	3MG;0.03MG	TABLET / ORAL-28	AB	RLD, RS	2001-05-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021098-001	YASMIN	3MG;0.03MG	TABLET / ORAL-28	AB	RLD, RS	2001-05-11	`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	N021098-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021098-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021098-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021098-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021098-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021098-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021098-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021098-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021098-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021098-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021098-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021098-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021098-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021098-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021098-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021098-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021098-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021098-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021098-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021098-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021098-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021098-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021098-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021098-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021098-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021098-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021098-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021098-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021098-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021098-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021098-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021098-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021098-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021098-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021098-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021098-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021098-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021098-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021098-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021098-001	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021098-001	6787531	2020-08-31	Drug product	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021098-001	6787531	2020-08-31	Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021098-001	6787531	2020-08-31	Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021098-001	6787531	2020-08-31	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021098-001	6787531	2020-08-31	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021098-001	6787531	2020-08-31	Drug product	`ea99ee380514…`

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
1a545a57-aed5-4b6e-b1f9-a93c26d50eff	Product name	1	20230829
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
94cad6dc-cea3-446b-a918-06fd714373a6	Product name	1	20211018
fa479cfe-0bd0-7366-d57a-92f3682e87c5	Product name	3	20210518
20e1a411-dba8-4afa-b9f9-1205d5b0bde9	Product name	3	20210513
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
89f15567-66a7-42ff-8abb-567b85d302d8	Product name	1	20190828
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
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
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
5e13e814-349e-3480-99f3-ee22a591426f	Product name	2	20150518
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3	Product name	1	20140508
83cac4be-cfee-33c1-5b8e-bb83ae18bce4	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
0555-9131-67	OCELLA	3 in 1 PACKAGE	KIT	3		28
0555-9131-79	OCELLA	1 in 1 BLISTER PACK	KIT	1		28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0555-9131-67	EA - Each	0555-9131	aa72b0e6-9f83-4ff7-b968-bf13300cd69d	1	2012-07-24
0555-9131-79	EA - Each	0555-9131	e64e1996-2a10-49e7-b0ba-3f674b8f3f74	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DROSPIRENONE	ACTIVE INGREDIENT	N295J34A25	OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]	8
ETHINYL ESTRADIOL	ACTIVE INGREDIENT	423D2T571U	OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]	8
DROSPIRENONE	ACTIVE MOIETY	N295J34A25	OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]	8
ETHINYL ESTRADIOL	ACTIVE MOIETY	423D2T571U	OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]	8
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]	8
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]	8
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]	8
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]	8
POVIDONE K25	INACTIVE INGREDIENT	K0KQV10C35	OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]	8
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]	8
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]	8
DROSPIRENONE	ACTIVE INGREDIENT	N295J34A25	OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]	2
ETHINYL ESTRADIOL	ACTIVE INGREDIENT	423D2T571U	OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]	2
DROSPIRENONE	ACTIVE MOIETY	N295J34A25	OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]	2
ETHINYL ESTRADIOL	ACTIVE MOIETY	423D2T571U	OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]	2
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]	2
POVIDONE K25	INACTIVE INGREDIENT	K0KQV10C35	OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0555-9131	OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [TEVA PHARMACEUTICALS USA, INC.]	24	Current NDC, Legacy NDC, 2 package rows	20241207_0d729f4d-2fa3-47f6-8a1f-d8cfea4cff37.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
Yasmin	DROSPIRENONE AND ETHINYL ESTRADIOL	Bayer HealthCare Pharmaceuticals Inc.	d7ea6a60-5a56-4f81-b206-9b27b7e58875	2023-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021098 application number: NDA021098

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
801185	{21 (drospirenone 3 MG / ethinyl estradiol 0.03 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Ocella 28 Day]	BPCK	0d729f4d-2fa3-47f6-8a1f-d8cfea4cff37	28
748800	{21 (drospirenone 3 MG / ethinyl estradiol 0.03 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack	GPCK	0d729f4d-2fa3-47f6-8a1f-d8cfea4cff37	28
748800	Drospiren-Eth estra 3-0.03 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack	PSN	0d729f4d-2fa3-47f6-8a1f-d8cfea4cff37	28
284207	drospirenone 3 MG / ethinyl estradiol 0.03 MG Oral Tablet	PSN	0d729f4d-2fa3-47f6-8a1f-d8cfea4cff37	28
748797	inert 1 MG Oral Tablet	PSN	0d729f4d-2fa3-47f6-8a1f-d8cfea4cff37	28
801185	Ocella 28 Day Pack	PSN	0d729f4d-2fa3-47f6-8a1f-d8cfea4cff37	28
284207	drospirenone 3 MG / ethinyl estradiol 0.03 MG Oral Tablet	SCD	0d729f4d-2fa3-47f6-8a1f-d8cfea4cff37	28
748797	inert ingredients 1 MG Oral Tablet	SCD	0d729f4d-2fa3-47f6-8a1f-d8cfea4cff37	28
801185	Ocella 28 Day Pack	SY	0d729f4d-2fa3-47f6-8a1f-d8cfea4cff37	28
801185	{21 (drospirenone 3 MG / ethinyl estradiol 0.03 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Ocella 28 Day]	BPCK	4fedeb6a-d99f-43e1-89f3-75818ce919aa	2
801185	{21 (drospirenone 3 MG / ethinyl estradiol 0.03 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Ocella 28 Day]	BPCK	7ca41896-abb1-43c2-99f8-7b3584ac8d7d	2
748800	{21 (drospirenone 3 MG / ethinyl estradiol 0.03 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack	GPCK	7ca41896-abb1-43c2-99f8-7b3584ac8d7d	2
748800	{21 (drospirenone 3 MG / ethinyl estradiol 0.03 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack	GPCK	4fedeb6a-d99f-43e1-89f3-75818ce919aa	2
748800	Drospiren-Eth estra 3-0.03 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack	PSN	7ca41896-abb1-43c2-99f8-7b3584ac8d7d	2
748800	Drospiren-Eth estra 3-0.03 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack	PSN	4fedeb6a-d99f-43e1-89f3-75818ce919aa	2
284207	drospirenone 3 MG / ethinyl estradiol 0.03 MG Oral Tablet	PSN	7ca41896-abb1-43c2-99f8-7b3584ac8d7d	2
284207	drospirenone 3 MG / ethinyl estradiol 0.03 MG Oral Tablet	PSN	4fedeb6a-d99f-43e1-89f3-75818ce919aa	2
748797	inert 1 MG Oral Tablet	PSN	4fedeb6a-d99f-43e1-89f3-75818ce919aa	2
748797	inert 1 MG Oral Tablet	PSN	7ca41896-abb1-43c2-99f8-7b3584ac8d7d	2
801185	Ocella 28 Day Pack	PSN	7ca41896-abb1-43c2-99f8-7b3584ac8d7d	2
801185	Ocella 28 Day Pack	PSN	4fedeb6a-d99f-43e1-89f3-75818ce919aa	2
284207	drospirenone 3 MG / ethinyl estradiol 0.03 MG Oral Tablet	SCD	7ca41896-abb1-43c2-99f8-7b3584ac8d7d	2
284207	drospirenone 3 MG / ethinyl estradiol 0.03 MG Oral Tablet	SCD	4fedeb6a-d99f-43e1-89f3-75818ce919aa	2
748797	inert ingredients 1 MG Oral Tablet	SCD	4fedeb6a-d99f-43e1-89f3-75818ce919aa	2
748797	inert ingredients 1 MG Oral Tablet	SCD	7ca41896-abb1-43c2-99f8-7b3584ac8d7d	2
801185	Ocella 28 Day Pack	SY	7ca41896-abb1-43c2-99f8-7b3584ac8d7d	2
801185	Ocella 28 Day Pack	SY	4fedeb6a-d99f-43e1-89f3-75818ce919aa	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0555-9131-67	00555913167	3 BLISTER PACK in 1 PACKAGE (0555-9131-67) / 1 KIT in 1 BLISTER PACK (0555-9131-79)	3 blister pack	2001-06-11	2026-06-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OCELLA	TEVA PHARMACEUTICALS USA, INC. \| Bayer HealthCare Pharmaceuticals Inc.	2026-03-04	HUMAN PRESCRIPTION DRUG LABEL	28
OCELLA	RPK Pharmaceuticals, Inc.	2023-07-03	HUMAN PRESCRIPTION DRUG LABEL	2
OCELLA ™ 28 TABLETS (drospirenone and ethinyl estradiol)	Physicians Total Care, Inc. \| Schering GmbH und Co. Produktions KG	2011-02-23	HUMAN PRESCRIPTION DRUG LABEL	2