FDA.reportPublic FDA data

OCELLA

Product NDC
0555-9131
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0555-9131DDiscontinued by firm2026-08-11
excluded packagepackage0555-91310555-9131-67DDiscontinued by firm2026-08-11

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021098-001YASMINDROSPIRENONE; ETHINYL ESTRADIOL3MG;0.03MGTABLET / ORAL-28ABRLD, RS2001-05-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N021098-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021098-001YASMIN3MG;0.03MGTABLET / ORAL-28ABRLD, RS2001-05-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021098-001YASMIN3MG;0.03MGTABLET / ORAL-28ABRLD, RS2001-05-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021098-001YASMIN3MG;0.03MGTABLET / ORAL-28ABRLD, RS2001-05-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021098-001YASMIN3MG;0.03MGTABLET / ORAL-28ABRLD, RS2001-05-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021098-001YASMIN3MG;0.03MGTABLET / ORAL-28ABRLD, RS2001-05-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021098-001YASMIN3MG;0.03MGTABLET / ORAL-28ABRLD, RS2001-05-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021098-001YASMIN3MG;0.03MGTABLET / ORAL-28ABRLD, RS2001-05-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021098-001YASMIN3MG;0.03MGTABLET / ORAL-28ABRLD, RS2001-05-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021098-001YASMIN3MG;0.03MGTABLET / ORAL-28ABRLD, RS2001-05-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021098-001YASMIN3MG;0.03MGTABLET / ORAL-28ABRLD, RS2001-05-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021098-001YASMIN3MG;0.03MGTABLET / ORAL-28ABRLD, RS2001-05-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021098-001YASMIN3MG;0.03MGTABLET / ORAL-28ABRLD, RS2001-05-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021098-001YASMIN3MG;0.03MGTABLET / ORAL-28ABRLD, RS2001-05-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021098-001YASMIN3MG;0.03MGTABLET / ORAL-28ABRLD, RS2001-05-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021098-001YASMIN3MG;0.03MGTABLET / ORAL-28ABRLD, RS2001-05-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021098-001YASMIN3MG;0.03MGTABLET / ORAL-28ABRLD, RS2001-05-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021098-001YASMIN3MG;0.03MGTABLET / ORAL-28ABRLD, RS2001-05-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021098-001YASMIN3MG;0.03MGTABLET / ORAL-28ABRLD, RS2001-05-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021098-001YASMIN3MG;0.03MGTABLET / ORAL-28ABRLD, RS2001-05-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021098-001YASMIN3MG;0.03MGTABLET / ORAL-28ABRLD, RS2001-05-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021098-001YASMIN3MG;0.03MGTABLET / ORAL-28ABRLD, RS2001-05-1187673890dc5c…
2021-03-12 10:30 UTC2021-03N021098-001YASMIN3MG;0.03MGTABLET / ORAL-28ABRLD, RS2001-05-115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021098-001YASMIN3MG;0.03MGTABLET / ORAL-28ABRLD, RS2001-05-118869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021098-001YASMIN3MG;0.03MGTABLET / ORAL-28ABRLD, RS2001-05-11c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021098-001YASMIN3MG;0.03MGTABLET / ORAL-28ABRLD, RS2001-05-113f01610625f2…
2019-09-15 20:21 UTC2019-09N021098-001YASMIN3MG;0.03MGTABLET / ORAL-28ABRLD, RS2001-05-11b00525d2431f…
2019-07-19 19:46 UTC2019-07N021098-001YASMIN3MG;0.03MGTABLET / ORAL-28ABRLD, RS2001-05-11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021098-001YASMIN3MG;0.03MGTABLET / ORAL-28ABRLD, RS2001-05-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021098-001YASMIN3MG;0.03MGTABLET / ORAL-28ABRLD, RS2001-05-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021098-001YASMIN3MG;0.03MGTABLET / ORAL-28ABRLD, RS2001-05-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021098-001YASMIN3MG;0.03MGTABLET / ORAL-28ABRLD, RS2001-05-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021098-001YASMIN3MG;0.03MGTABLET / ORAL-28ABRLD, RS2001-05-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021098-001YASMIN3MG;0.03MGTABLET / ORAL-28ABRLD, RS2001-05-11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021098-001YASMIN3MG;0.03MGTABLET / ORAL-28ABRLD, RS2001-05-113f0d92c62455…
2023-05-13 08:27 UTC2023-05N021098-001YASMIN3MG;0.03MGTABLET / ORAL-28ABRLD, RS2001-05-11053a50430f4f…
2023-01-26 05:58 UTC2023-01N021098-001YASMIN3MG;0.03MGTABLET / ORAL-28ABRLD, RS2001-05-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021098-001YASMIN3MG;0.03MGTABLET / ORAL-28ABRLD, RS2001-05-113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021098-001YASMIN3MG;0.03MGTABLET / ORAL-28ABRLD, RS2001-05-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021098-001YASMIN3MG;0.03MGTABLET / ORAL-28ABRLD, RS2001-05-11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021098-001YASMIN3MG;0.03MGTABLET / ORAL-28ABRLD, RS2001-05-11cb3db0bc1861…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021098-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021098-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021098-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021098-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021098-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021098-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021098-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021098-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021098-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021098-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021098-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021098-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021098-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021098-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021098-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021098-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021098-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021098-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021098-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021098-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021098-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N021098-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021098-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021098-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021098-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N021098-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021098-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021098-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021098-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021098-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021098-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021098-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021098-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021098-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N021098-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N021098-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021098-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021098-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021098-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021098-001AB1cb3db0bc1861…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021098-00167875312020-08-31Drug product74a2ff9319b5…
2020-12-22 03:56 UTC2020-12N021098-00167875312020-08-31Drug product8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021098-00167875312020-08-31Drug productc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021098-00167875312020-08-31Drug product3f01610625f2…
2019-09-15 20:21 UTC2019-09N021098-00167875312020-08-31Drug productb00525d2431f…
2019-07-19 19:46 UTC2019-07N021098-00167875312020-08-31Drug productea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1ecea64-06d1-4fdc-a2a1-b801e0cd0d11Product name420250623
d39a542a-f5b0-4c2d-a820-0f5d39e6621fProduct name120250307
8511fc19-172b-4e1f-90ec-2f09c85b16deProduct name220250116
d9a998ac-31a9-4391-9054-c30e50912603Product name220240829
782f1593-b73e-4d35-8017-647969d714d8Product name420240805
1a545a57-aed5-4b6e-b1f9-a93c26d50effProduct name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a0f93f28-4e91-4bb1-8dcb-5456fd4bfc50Product name320230718
a057e1a7-94b1-4663-8d17-a3bbf3a12689Product name520230627
0d9f32e2-f85b-4d63-9f04-b06059c34749Product name320230323
94cad6dc-cea3-446b-a918-06fd714373a6Product name120211018
fa479cfe-0bd0-7366-d57a-92f3682e87c5Product name320210518
20e1a411-dba8-4afa-b9f9-1205d5b0bde9Product name320210513
cec4644c-0fed-4608-a5ea-d3a1b1b6d697Product name220200728
00a01e22-7ea3-6f8f-0cc1-380aac10f424Product name620200716
5956a0e2-c373-452c-bdcf-c93d354432efProduct name120200714
ca306105-d51c-4821-9ec1-8eec753d073dProduct name120200619
f1d1b304-0b6c-25e9-a872-86d3d4bd2ab9Product name820200612
0381745d-0d4c-bcc1-87eb-abb98c1e6cb6Product name820191120
89f15567-66a7-42ff-8abb-567b85d302d8Product name120190828
6dd982ab-2966-22ee-3b75-d225abb791aaProduct name520190612
d2c4820a-bb24-f61d-8cd0-dd0290a6bd4dProduct name720190612
f92411e4-13dd-7baf-106e-9b3fcf758c39Product name420190502
60ff9adc-7870-42ca-8836-514bd9732fa8Product name420181220
ddff2484-d547-4e6a-bacd-95eef7e31c64Product name220180807
c6636356-4ccb-40e9-a952-59eb1f2fc859Product name420180806
79d5025d-8129-440a-b861-6df2d2661609Product name320180607
e042bc86-5d40-8945-82f8-de9dd95420ddProduct name620180606
d871c48c-6b0b-4203-b55d-72ead21ea7adProduct name520180419
90854981-3820-4bc4-a1d3-666ec508941cProduct name220180214
390e6d23-3a11-4327-9294-c958a378baaeProduct name420180124
12434b90-2738-45d5-9e1b-55001e853273Product name220171122
b651f154-0364-4007-9dc6-9d33036db1d7Product name420170808
3395ac9b-f30b-4991-80ba-fd5196be0214Product name320170802
2d386545-84d1-e1e9-1402-7fc8962353e8Product name220170717
a5e2d962-d98c-4fbf-8183-ffd42dd01e19Product name620170711
30783b73-16b0-4cc1-b03a-e5d801c0d7a8Product name420170608
00606b81-6e33-4c38-9ca9-bd14bd74d84cProduct name420170501
f4ce24e8-8632-4fad-9984-b693f985f80fProduct name320170501
b17c5419-b38b-579f-10bc-8a4ce69fc044Product name520170316
120cc5ad-761c-444c-9e82-dec22f96dfe1Product name720161219
01996782-abcb-4e6d-bcaf-4a23e6a95c0cProduct name120160714
2aecf0b6-88a0-49e5-92e1-983c700c116cProduct name120151222
61972742-5d4d-491d-a881-b6bc3a011577Product name120151113
5e13e814-349e-3480-99f3-ee22a591426fProduct name220150518
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3Product name120140508
83cac4be-cfee-33c1-5b8e-bb83ae18bce4Product name120140508
d0cc7d42-77a7-b452-c6c3-a162fa11225fProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0555-9131-67OCELLA3 in 1 PACKAGEKIT328
0555-9131-79OCELLA1 in 1 BLISTER PACKKIT128

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0555-9131-67EA - Each0555-9131aa72b0e6-9f83-4ff7-b968-bf13300cd69d12012-07-24
0555-9131-79EA - Each0555-9131e64e1996-2a10-49e7-b0ba-3f674b8f3f7412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DROSPIRENONEACTIVE INGREDIENTN295J34A25OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]8
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UOCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]8
DROSPIRENONEACTIVE MOIETYN295J34A25OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]8
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UOCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTOCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]8
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEOCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]8
POVIDONE K25INACTIVE INGREDIENTK0KQV10C35OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]8
TALCINACTIVE INGREDIENT7SEV7J4R1UOCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES, INC.]8
DROSPIRENONEACTIVE INGREDIENTN295J34A25OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UOCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
DROSPIRENONEACTIVE MOIETYN295J34A25OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UOCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTOCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEOCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
POVIDONE K25INACTIVE INGREDIENTK0KQV10C35OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UOCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0555-9131OCELLA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [TEVA PHARMACEUTICALS USA, INC.]24Current NDC, Legacy NDC, 2 package rows20241207_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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
YasminDROSPIRENONE AND ETHINYL ESTRADIOLBayer HealthCare Pharmaceuticals Inc.d7ea6a60-5a56-4f81-b206-9b27b7e588752023-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021098
application number: NDA021098

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
801185{21 (drospirenone 3 MG / ethinyl estradiol 0.03 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Ocella 28 Day]BPCK0d729f4d-2fa3-47f6-8a1f-d8cfea4cff3728
748800{21 (drospirenone 3 MG / ethinyl estradiol 0.03 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK0d729f4d-2fa3-47f6-8a1f-d8cfea4cff3728
748800Drospiren-Eth estra 3-0.03 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN0d729f4d-2fa3-47f6-8a1f-d8cfea4cff3728
284207drospirenone 3 MG / ethinyl estradiol 0.03 MG Oral TabletPSN0d729f4d-2fa3-47f6-8a1f-d8cfea4cff3728
748797inert 1 MG Oral TabletPSN0d729f4d-2fa3-47f6-8a1f-d8cfea4cff3728
801185Ocella 28 Day PackPSN0d729f4d-2fa3-47f6-8a1f-d8cfea4cff3728
284207drospirenone 3 MG / ethinyl estradiol 0.03 MG Oral TabletSCD0d729f4d-2fa3-47f6-8a1f-d8cfea4cff3728
748797inert ingredients 1 MG Oral TabletSCD0d729f4d-2fa3-47f6-8a1f-d8cfea4cff3728
801185Ocella 28 Day PackSY0d729f4d-2fa3-47f6-8a1f-d8cfea4cff3728
801185{21 (drospirenone 3 MG / ethinyl estradiol 0.03 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Ocella 28 Day]BPCK4fedeb6a-d99f-43e1-89f3-75818ce919aa2
801185{21 (drospirenone 3 MG / ethinyl estradiol 0.03 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Ocella 28 Day]BPCK7ca41896-abb1-43c2-99f8-7b3584ac8d7d2
748800{21 (drospirenone 3 MG / ethinyl estradiol 0.03 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK7ca41896-abb1-43c2-99f8-7b3584ac8d7d2
748800{21 (drospirenone 3 MG / ethinyl estradiol 0.03 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK4fedeb6a-d99f-43e1-89f3-75818ce919aa2
748800Drospiren-Eth estra 3-0.03 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN7ca41896-abb1-43c2-99f8-7b3584ac8d7d2
748800Drospiren-Eth estra 3-0.03 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN4fedeb6a-d99f-43e1-89f3-75818ce919aa2
284207drospirenone 3 MG / ethinyl estradiol 0.03 MG Oral TabletPSN7ca41896-abb1-43c2-99f8-7b3584ac8d7d2
284207drospirenone 3 MG / ethinyl estradiol 0.03 MG Oral TabletPSN4fedeb6a-d99f-43e1-89f3-75818ce919aa2
748797inert 1 MG Oral TabletPSN4fedeb6a-d99f-43e1-89f3-75818ce919aa2
748797inert 1 MG Oral TabletPSN7ca41896-abb1-43c2-99f8-7b3584ac8d7d2
801185Ocella 28 Day PackPSN7ca41896-abb1-43c2-99f8-7b3584ac8d7d2
801185Ocella 28 Day PackPSN4fedeb6a-d99f-43e1-89f3-75818ce919aa2
284207drospirenone 3 MG / ethinyl estradiol 0.03 MG Oral TabletSCD7ca41896-abb1-43c2-99f8-7b3584ac8d7d2
284207drospirenone 3 MG / ethinyl estradiol 0.03 MG Oral TabletSCD4fedeb6a-d99f-43e1-89f3-75818ce919aa2
748797inert ingredients 1 MG Oral TabletSCD4fedeb6a-d99f-43e1-89f3-75818ce919aa2
748797inert ingredients 1 MG Oral TabletSCD7ca41896-abb1-43c2-99f8-7b3584ac8d7d2
801185Ocella 28 Day PackSY7ca41896-abb1-43c2-99f8-7b3584ac8d7d2
801185Ocella 28 Day PackSY4fedeb6a-d99f-43e1-89f3-75818ce919aa2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0555-9131-67005559131673 BLISTER PACK in 1 PACKAGE (0555-9131-67) / 1 KIT in 1 BLISTER PACK (0555-9131-79) 3 blister pack2001-06-112026-06-30NoNoCurrent
0555-9131-79005559131791 in 1 BLISTER PACKHistorical