FDA.reportPublic FDA data

Cryselle

Product NDC
0555-9049
11-digit product format
005559049
Labeler code
0555
Product ID
0555-9049_1fa9262a-8c57-4a86-b5aa-b331d1612fe2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Norgestrel and Ethinyl Estradiol
Dosage form
KIT
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA075840
Marketing category
ANDA
Marketing start
2002-07-24
Marketing end
2027-01-31
NDC exclude flag
No
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075840-001CRYSELLEETHINYL ESTRADIOL; NORGESTREL0.03MG;0.3MGTABLET / ORAL-21AB2001-11-30
A075840-002CRYSELLEETHINYL ESTRADIOL; NORGESTREL0.03MG;0.3MGTABLET / ORAL-28ABRS2001-11-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A075840-001AB
A075840-002AB

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075840-001CRYSELLE0.03MG;0.3MGTABLET / ORAL-21AB2001-11-3084e616aacf4f…
2026-09-14 22:38:342026-08A075840-002CRYSELLE0.03MG;0.3MGTABLET / ORAL-28ABRS2001-11-3084e616aacf4f…
2026-08-18 06:07:402026-07A075840-001CRYSELLE0.03MG;0.3MGTABLET / ORAL-21AB2001-11-30caaa826d4ba7…
2026-08-18 06:07:402026-07A075840-002CRYSELLE0.03MG;0.3MGTABLET / ORAL-28ABRS2001-11-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075840-001CRYSELLE0.03MG;0.3MGTABLET / ORAL-21AB2001-11-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075840-002CRYSELLE0.03MG;0.3MGTABLET / ORAL-28ABRS2001-11-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075840-001CRYSELLE0.03MG;0.3MGTABLET / ORAL-21AB2001-11-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075840-002CRYSELLE0.03MG;0.3MGTABLET / ORAL-28ABRS2001-11-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A075840-001CRYSELLE0.03MG;0.3MGTABLET / ORAL-21AB2001-11-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075840-002CRYSELLE0.03MG;0.3MGTABLET / ORAL-28ABRS2001-11-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075840-001CRYSELLE0.03MG;0.3MGTABLET / ORAL-21AB2001-11-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075840-002CRYSELLE0.03MG;0.3MGTABLET / ORAL-28ABRS2001-11-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075840-001CRYSELLE0.03MG;0.3MGTABLET / ORAL-21AB2001-11-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075840-002CRYSELLE0.03MG;0.3MGTABLET / ORAL-28ABRS2001-11-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075840-001CRYSELLE0.03MG;0.3MGTABLET / ORAL-21AB2001-11-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075840-002CRYSELLE0.03MG;0.3MGTABLET / ORAL-28ABRS2001-11-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075840-001CRYSELLE0.03MG;0.3MGTABLET / ORAL-21AB2001-11-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075840-002CRYSELLE0.03MG;0.3MGTABLET / ORAL-28ABRS2001-11-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075840-001CRYSELLE0.03MG;0.3MGTABLET / ORAL-21AB2001-11-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075840-002CRYSELLE0.03MG;0.3MGTABLET / ORAL-28ABRS2001-11-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075840-001CRYSELLE0.03MG;0.3MGTABLET / ORAL-21AB2001-11-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075840-002CRYSELLE0.03MG;0.3MGTABLET / ORAL-28ABRS2001-11-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075840-001CRYSELLE0.03MG;0.3MGTABLET / ORAL-21AB2001-11-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A075840-002CRYSELLE0.03MG;0.3MGTABLET / ORAL-28ABRS2001-11-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075840-001CRYSELLE0.03MG;0.3MGTABLET / ORAL-21AB2001-11-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075840-002CRYSELLE0.03MG;0.3MGTABLET / ORAL-28ABRS2001-11-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075840-001CRYSELLE0.03MG;0.3MGTABLET / ORAL-21AB2001-11-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075840-002CRYSELLE0.03MG;0.3MGTABLET / ORAL-28ABRS2001-11-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075840-001CRYSELLE0.03MG;0.3MGTABLET / ORAL-21AB2001-11-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075840-002CRYSELLE0.03MG;0.3MGTABLET / ORAL-28ABRS2001-11-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075840-001CRYSELLE0.03MG;0.3MGTABLET / ORAL-21AB2001-11-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075840-002CRYSELLE0.03MG;0.3MGTABLET / ORAL-28ABRS2001-11-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075840-001CRYSELLE0.03MG;0.3MGTABLET / ORAL-21AB2001-11-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075840-002CRYSELLE0.03MG;0.3MGTABLET / ORAL-28ABRS2001-11-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075840-001CRYSELLE0.03MG;0.3MGTABLET / ORAL-21AB2001-11-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075840-002CRYSELLE0.03MG;0.3MGTABLET / ORAL-28AB2001-11-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075840-001CRYSELLE0.03MG;0.3MGTABLET / ORAL-21AB2001-11-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075840-002CRYSELLE0.03MG;0.3MGTABLET / ORAL-28AB2001-11-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075840-001CRYSELLE0.03MG;0.3MGTABLET / ORAL-21AB2001-11-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075840-002CRYSELLE0.03MG;0.3MGTABLET / ORAL-28AB2001-11-3074a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A075840-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A075840-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A075840-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075840-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075840-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075840-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075840-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075840-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075840-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075840-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075840-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075840-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075840-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075840-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075840-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075840-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075840-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075840-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075840-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075840-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075840-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075840-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075840-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075840-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075840-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075840-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075840-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075840-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075840-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075840-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075840-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075840-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075840-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075840-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075840-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075840-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075840-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075840-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075840-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075840-002AB174a2ff9319b5…

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
Cryselle

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311359Internal RxNorm lookup
748797Internal RxNorm lookup
749786Internal RxNorm lookup
750265Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ee6be128-d494-4361-9a0d-341c0eee3587Available 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
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
0555-9049-58Cryselle6 in 1 CARTONKIT615
0555-9049-79Cryselle1 in 1 BLISTER PACKKIT115
0555-9049-79Cryselle1 in 1 POUCHKIT115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0555-9049-58EA - Each0555-9049d363784a-eb4d-4cbd-88b6-3017430508e912013-02-13
0555-9049-79EA - Each0555-904987c812cf-97ed-458d-8785-498ab7bfb13d12017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
NORGESTRELACTIVE INGREDIENT3J8Q1747Z2CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
NORGESTRELACTIVE MOIETY3J8Q1747Z2CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
NORGESTRELACTIVE INGREDIENT3J8Q1747Z2CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
NORGESTRELACTIVE MOIETY3J8Q1747Z2CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ACRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0555-9049CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [TEVA PHARMACEUTICALS USA, INC.]14Current NDC, Legacy NDC, 3 package rows20220827_ee6be128-d494-4361-9a0d-341c0eee3587.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CryselleNORGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutionsf73ece43-6b5f-4abb-ba6d-4d62775f2f8e2026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075840
application number: ANDA075840
CryselleNORGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutionsfcf4f8ea-1eb3-4a43-87d2-16f93e9044432024-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075840
application number: ANDA075840
CryselleNORGESTREL AND ETHINYL ESTRADIOLProficient Rx LP9c4fac8e-8744-4378-80af-7887de955a512023-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075840
application number: ANDA075840
CryselleNORGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.ee6be128-d494-4361-9a0d-341c0eee35872022-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075840
application number: ANDA075840
ndc (product): 0555-9049

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
750265{21 (ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Cryselle 28]BPCKee6be128-d494-4361-9a0d-341c0eee358715
750265{21 (ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Cryselle 28]BPCKfcf4f8ea-1eb3-4a43-87d2-16f93e90444315
749786{21 (ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCKee6be128-d494-4361-9a0d-341c0eee358715
749786{21 (ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCKfcf4f8ea-1eb3-4a43-87d2-16f93e90444315
750265Cryselle 28 Day PackPSNee6be128-d494-4361-9a0d-341c0eee358715
750265Cryselle 28 Day PackPSNfcf4f8ea-1eb3-4a43-87d2-16f93e90444315
749786eth estra-norgestrel 0.03-0.3 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSNee6be128-d494-4361-9a0d-341c0eee358715
749786eth estra-norgestrel 0.03-0.3 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSNfcf4f8ea-1eb3-4a43-87d2-16f93e90444315
748797inert 1 MG Oral TabletPSNee6be128-d494-4361-9a0d-341c0eee358715
748797inert 1 MG Oral TabletPSNfcf4f8ea-1eb3-4a43-87d2-16f93e90444315
311359norgestrel 0.3 MG / ethinyl estradiol 0.03 MG Oral TabletPSNee6be128-d494-4361-9a0d-341c0eee358715
311359norgestrel 0.3 MG / ethinyl estradiol 0.03 MG Oral TabletPSNfcf4f8ea-1eb3-4a43-87d2-16f93e90444315
311359ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral TabletSCDee6be128-d494-4361-9a0d-341c0eee358715
311359ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral TabletSCDfcf4f8ea-1eb3-4a43-87d2-16f93e90444315
748797inert ingredients 1 MG Oral TabletSCDee6be128-d494-4361-9a0d-341c0eee358715
748797inert ingredients 1 MG Oral TabletSCDfcf4f8ea-1eb3-4a43-87d2-16f93e90444315
750265Cryselle 28 Day PackSYee6be128-d494-4361-9a0d-341c0eee358715
750265Cryselle 28 Day PackSYfcf4f8ea-1eb3-4a43-87d2-16f93e90444315
311359ethinyl estradiol 30 MCG / norgestrel 0.3 MG Oral TabletSYee6be128-d494-4361-9a0d-341c0eee358715
311359ethinyl estradiol 30 MCG / norgestrel 0.3 MG Oral TabletSYfcf4f8ea-1eb3-4a43-87d2-16f93e90444315
750265{21 (ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Cryselle 28]BPCK9ef8ffe1-5cba-47dc-a405-dd523d76abb53
749786{21 (ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK9ef8ffe1-5cba-47dc-a405-dd523d76abb53
750265Cryselle 28 Day PackPSN9ef8ffe1-5cba-47dc-a405-dd523d76abb53
749786eth estra-norgestrel 0.03-0.3 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN9ef8ffe1-5cba-47dc-a405-dd523d76abb53
748797inert 1 MG Oral TabletPSN9ef8ffe1-5cba-47dc-a405-dd523d76abb53
311359norgestrel 0.3 MG / ethinyl estradiol 0.03 MG Oral TabletPSN9ef8ffe1-5cba-47dc-a405-dd523d76abb53
311359ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral TabletSCD9ef8ffe1-5cba-47dc-a405-dd523d76abb53
748797inert ingredients 1 MG Oral TabletSCD9ef8ffe1-5cba-47dc-a405-dd523d76abb53
750265Cryselle 28 Day PackSY9ef8ffe1-5cba-47dc-a405-dd523d76abb53
311359ethinyl estradiol 30 MCG / norgestrel 0.3 MG Oral TabletSY9ef8ffe1-5cba-47dc-a405-dd523d76abb53
750265{21 (ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Cryselle 28]BPCK22e5d50a-a772-4e90-82f8-b49ecdf916102
749786{21 (ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK22e5d50a-a772-4e90-82f8-b49ecdf916102
750265Cryselle 28 Day PackPSN22e5d50a-a772-4e90-82f8-b49ecdf916102
749786eth estra-norgestrel 0.03-0.3 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN22e5d50a-a772-4e90-82f8-b49ecdf916102
748797inert 1 MG Oral TabletPSN22e5d50a-a772-4e90-82f8-b49ecdf916102
311359norgestrel 0.3 MG / ethinyl estradiol 0.03 MG Oral TabletPSN22e5d50a-a772-4e90-82f8-b49ecdf916102
311359ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral TabletSCD22e5d50a-a772-4e90-82f8-b49ecdf916102
748797inert ingredients 1 MG Oral TabletSCD22e5d50a-a772-4e90-82f8-b49ecdf916102
750265Cryselle 28 Day PackSY22e5d50a-a772-4e90-82f8-b49ecdf916102
311359ethinyl estradiol 30 MCG / norgestrel 0.3 MG Oral TabletSY22e5d50a-a772-4e90-82f8-b49ecdf916102
750265{21 (ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Cryselle 28]BPCKcf19bbd6-91d1-4cbd-9fc4-5c750451f6661
750265{21 (ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Cryselle 28]BPCK9c4fac8e-8744-4378-80af-7887de955a511
749786{21 (ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCKcf19bbd6-91d1-4cbd-9fc4-5c750451f6661
749786{21 (ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK9c4fac8e-8744-4378-80af-7887de955a511
750265Cryselle 28 Day PackPSNcf19bbd6-91d1-4cbd-9fc4-5c750451f6661
750265Cryselle 28 Day PackPSN9c4fac8e-8744-4378-80af-7887de955a511
749786eth estra-norgestrel 0.03-0.3 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSNcf19bbd6-91d1-4cbd-9fc4-5c750451f6661
749786eth estra-norgestrel 0.03-0.3 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN9c4fac8e-8744-4378-80af-7887de955a511
748797inert 1 MG Oral TabletPSNcf19bbd6-91d1-4cbd-9fc4-5c750451f6661
748797inert 1 MG Oral TabletPSN9c4fac8e-8744-4378-80af-7887de955a511
311359norgestrel 0.3 MG / ethinyl estradiol 0.03 MG Oral TabletPSN9c4fac8e-8744-4378-80af-7887de955a511
311359norgestrel 0.3 MG / ethinyl estradiol 0.03 MG Oral TabletPSNcf19bbd6-91d1-4cbd-9fc4-5c750451f6661
311359ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral TabletSCD9c4fac8e-8744-4378-80af-7887de955a511
311359ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral TabletSCDcf19bbd6-91d1-4cbd-9fc4-5c750451f6661
748797inert ingredients 1 MG Oral TabletSCDcf19bbd6-91d1-4cbd-9fc4-5c750451f6661
748797inert ingredients 1 MG Oral TabletSCD9c4fac8e-8744-4378-80af-7887de955a511
750265Cryselle 28 Day PackSYcf19bbd6-91d1-4cbd-9fc4-5c750451f6661
750265Cryselle 28 Day PackSY9c4fac8e-8744-4378-80af-7887de955a511
311359ethinyl estradiol 30 MCG / norgestrel 0.3 MG Oral TabletSY9c4fac8e-8744-4378-80af-7887de955a511
311359ethinyl estradiol 30 MCG / norgestrel 0.3 MG Oral TabletSYcf19bbd6-91d1-4cbd-9fc4-5c750451f6661

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0555-9049-58005559049586 POUCH in 1 CARTON (0555-9049-58) / 1 BLISTER PACK in 1 POUCH (0555-9049-79) / 1 KIT in 1 BLISTER PACK6 pouch2002-07-242027-01-31NoNoCurrent
0555-9049-79005559049791 in 1 BLISTER PACKHistorical