Kariva

Product NDC
0555-9050
11-digit product format
005559050
Labeler code
0555
Product ID
0555-9050_ad406427-c901-4f7c-9b4f-68bd0667593d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desogestrel/Ethinyl Estradiol and Ethinyl Estradiol
Dosage form
KIT
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA075863
Marketing category
ANDA
Marketing start
2002-04-08
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075863-001KARIVADESOGESTREL; ETHINYL ESTRADIOL0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28ABRS2002-04-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075863-001AB

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075863-001KARIVA0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28ABRS2002-04-0584e616aacf4f…
2026-08-18 06:07:402026-07A075863-001KARIVA0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28ABRS2002-04-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075863-001KARIVA0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28ABRS2002-04-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075863-001KARIVA0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28ABRS2002-04-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A075863-001KARIVA0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28ABRS2002-04-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075863-001KARIVA0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28ABRS2002-04-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075863-001KARIVA0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28ABRS2002-04-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075863-001KARIVA0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28ABRS2002-04-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075863-001KARIVA0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28ABRS2002-04-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075863-001KARIVA0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28ABRS2002-04-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075863-001KARIVA0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28ABRS2002-04-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075863-001KARIVA0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28ABRS2002-04-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075863-001KARIVA0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28ABRS2002-04-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075863-001KARIVA0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28ABRS2002-04-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075863-001KARIVA0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28ABRS2002-04-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075863-001KARIVA0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28ABRS2002-04-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075863-001KARIVA0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28ABRS2002-04-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075863-001KARIVA0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28ABRS2002-04-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075863-001KARIVA0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28ABRS2002-04-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075863-001KARIVA0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28ABRS2002-04-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075863-001KARIVA0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28ABRS2002-04-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075863-001KARIVA0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28ABRS2002-04-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075863-001KARIVA0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28ABRS2002-04-0587673890dc5c…
2021-03-12 10:30 UTC2021-03A075863-001KARIVA0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28ABRS2002-04-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075863-001KARIVA0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28ABRS2002-04-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075863-001KARIVA0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28ABRS2002-04-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075863-001KARIVA0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28ABRS2002-04-053f01610625f2…
2019-09-15 20:21 UTC2019-09A075863-001KARIVA0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28ABRS2002-04-05b00525d2431f…
2019-07-19 19:46 UTC2019-07A075863-001KARIVA0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28ABRS2002-04-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075863-001KARIVA0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28ABRS2002-04-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075863-001KARIVA0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28ABRS2002-04-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075863-001KARIVA0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28ABRS2002-04-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075863-001KARIVA0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28ABRS2002-04-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075863-001KARIVA0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28ABRS2002-04-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075863-001KARIVA0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28ABRS2002-04-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075863-001KARIVA0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28ABRS2002-04-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A075863-001KARIVA0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28ABRS2002-04-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A075863-001KARIVA0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28ABRS2002-04-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075863-001KARIVA0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28ABRS2002-04-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075863-001KARIVA0.15MG,N/A;0.02MG,0.01MGTABLET / ORAL-28ABRS2002-04-05f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A075863-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A075863-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075863-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075863-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075863-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075863-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075863-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075863-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075863-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075863-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075863-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075863-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075863-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075863-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075863-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075863-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075863-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075863-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075863-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075863-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075863-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075863-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075863-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A075863-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075863-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075863-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075863-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A075863-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075863-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075863-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075863-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075863-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075863-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075863-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075863-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075863-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A075863-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A075863-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075863-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075863-001AB1f41ea6bd6efb…

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
Kariva
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
248310Internal RxNorm lookup
249357Internal RxNorm lookup
748797Internal RxNorm lookup
759743Internal RxNorm lookup
762001Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7b11e11f-6977-4109-b9bd-a066e5d1278aAvailable on FDA.report

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
a0f93f28-4e91-4bb1-8dcb-5456fd4bfc50Product name320230718
a057e1a7-94b1-4663-8d17-a3bbf3a12689Product name520230627
0d9f32e2-f85b-4d63-9f04-b06059c34749Product name320230323
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
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
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
d0cc7d42-77a7-b452-c6c3-a162fa11225fProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0555-9050-58Kariva6 in 1 CARTONKIT615
0555-9050-79Kariva1 in 1 BLISTER PACKKIT115
0555-9050-79Kariva1 in 1 POUCHKIT115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0555-9050-58EA - Each0555-9050f38a8958-0aa0-4e48-9b93-27c009e086db12012-07-24
0555-9050-79EA - Each0555-90501f011883-0423-4bdd-aac8-3727c2aed71a12017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DESOGESTRELACTIVE INGREDIENT81K9V7M3A3KARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UKARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
DESOGESTRELACTIVE MOIETY81K9V7M3A3KARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UKARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1KARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933KARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UKARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GKARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDKARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKKARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8KARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82KARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
HYPROMELLOSE 2910 (50 MPA.S)INACTIVE INGREDIENT1IVH67816NKARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6KARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
INDIGOTINDISULFONATE SODIUMINACTIVE INGREDIENTD3741U8K7LKARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XKARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30KARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEKARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQKARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BKARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
POVIDONE K30INACTIVE INGREDIENTU725QWY32XKARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4KARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJKARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APKARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPKARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
TRIACETININACTIVE INGREDIENTXHX3C3X673KARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
DESOGESTRELACTIVE INGREDIENT81K9V7M3A3KARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UKARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
DESOGESTRELACTIVE MOIETY81K9V7M3A3KARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UKARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1KARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933KARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UKARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GKARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDKARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKKARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8KARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOKARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XKARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30KARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEKARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AKARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EKARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4KARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJKARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APKARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPKARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
TRIACETININACTIVE INGREDIENTXHX3C3X673KARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0555-9050KARIVA (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA PHARMACEUTICALS USA, INC.]15Current NDC, Legacy NDC, 3 package rows20240420_7b11e11f-6977-4109-b9bd-a066e5d1278a.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
KarivaDESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.7b11e11f-6977-4109-b9bd-a066e5d1278a2024-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075863
application number: ANDA075863
ndc (product): 0555-9050

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
762001{21 (desogestrel 0.15 MG / ethinyl estradiol 0.02 MG Oral Tablet) / 5 (ethinyl estradiol 0.01 MG Oral Tablet) / 2 (inert ingredients 1 MG Oral Tablet) } Pack [Kariva 28 Day]BPCK7b11e11f-6977-4109-b9bd-a066e5d1278a15
759743{21 (desogestrel 0.15 MG / ethinyl estradiol 0.02 MG Oral Tablet) / 5 (ethinyl estradiol 0.01 MG Oral Tablet) / 2 (inert ingredients 1 MG Oral Tablet) } PackGPCK7b11e11f-6977-4109-b9bd-a066e5d1278a15
759743Desogest-Eth estra 0.15-0.02 MG (21) Oral Tablet / Eth estra 0.01 MG (5) Oral Tablet / Inert 1 MG (2) Oral Tablet 28 Day PackPSN7b11e11f-6977-4109-b9bd-a066e5d1278a15
249357desogestrel 0.15 MG / ethinyl estradiol 0.02 MG Oral TabletPSN7b11e11f-6977-4109-b9bd-a066e5d1278a15
248310ethinyl estradiol 0.01 MG Oral TabletPSN7b11e11f-6977-4109-b9bd-a066e5d1278a15
748797inert 1 MG Oral TabletPSN7b11e11f-6977-4109-b9bd-a066e5d1278a15
762001Kariva 28 Day PackPSN7b11e11f-6977-4109-b9bd-a066e5d1278a15
249357desogestrel 0.15 MG / ethinyl estradiol 0.02 MG Oral TabletSCD7b11e11f-6977-4109-b9bd-a066e5d1278a15
248310ethinyl estradiol 0.01 MG Oral TabletSCD7b11e11f-6977-4109-b9bd-a066e5d1278a15
748797inert ingredients 1 MG Oral TabletSCD7b11e11f-6977-4109-b9bd-a066e5d1278a15
248310ethinyl estradiol 10 MCG Oral TabletSY7b11e11f-6977-4109-b9bd-a066e5d1278a15
762001Kariva 28 Day PackSY7b11e11f-6977-4109-b9bd-a066e5d1278a15
762001{21 (desogestrel 0.15 MG / ethinyl estradiol 0.02 MG Oral Tablet) / 5 (ethinyl estradiol 0.01 MG Oral Tablet) / 2 (inert ingredients 1 MG Oral Tablet) } Pack [Kariva 28 Day]BPCKa7afffba-774f-4136-ac34-44fe8561c2e11
759743{21 (desogestrel 0.15 MG / ethinyl estradiol 0.02 MG Oral Tablet) / 5 (ethinyl estradiol 0.01 MG Oral Tablet) / 2 (inert ingredients 1 MG Oral Tablet) } PackGPCKa7afffba-774f-4136-ac34-44fe8561c2e11
759743Desogest-Eth estra 0.15-0.02 MG (21) Oral Tablet / Eth estra 0.01 MG (5) Oral Tablet / Inert 1 MG (2) Oral Tablet 28 Day PackPSNa7afffba-774f-4136-ac34-44fe8561c2e11
249357desogestrel 0.15 MG / ethinyl estradiol 0.02 MG Oral TabletPSNa7afffba-774f-4136-ac34-44fe8561c2e11
248310ethinyl estradiol 0.01 MG Oral TabletPSNa7afffba-774f-4136-ac34-44fe8561c2e11
748797inert 1 MG Oral TabletPSNa7afffba-774f-4136-ac34-44fe8561c2e11
762001Kariva 28 Day PackPSNa7afffba-774f-4136-ac34-44fe8561c2e11
249357desogestrel 0.15 MG / ethinyl estradiol 0.02 MG Oral TabletSCDa7afffba-774f-4136-ac34-44fe8561c2e11
248310ethinyl estradiol 0.01 MG Oral TabletSCDa7afffba-774f-4136-ac34-44fe8561c2e11
748797inert ingredients 1 MG Oral TabletSCDa7afffba-774f-4136-ac34-44fe8561c2e11
248310ethinyl estradiol 10 MCG Oral TabletSYa7afffba-774f-4136-ac34-44fe8561c2e11
762001Kariva 28 Day PackSYa7afffba-774f-4136-ac34-44fe8561c2e11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0555-9050-58005559050586 POUCH in 1 CARTON (0555-9050-58) / 1 BLISTER PACK in 1 POUCH (0555-9050-79) / 1 KIT in 1 BLISTER PACK6 pouch2002-04-080000-00-00NoNoCurrent
0555-9050-79005559050791 in 1 BLISTER PACKHistorical