Cyclafem 1/35

Product NDC
0603-7521
Requested package NDC
0603-7521-49
11-digit product format
006037521
Labeler code
0603
Product ID
0603-7521_216c7cea-d247-41dd-a05b-6f6e5345d642
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
norethindrone and ethinyl estradiol
Dosage form
KIT
Labeler
Par Pharmaceutical, Inc.
Application
ANDA076337
Marketing category
ANDA
Marketing start
2010-11-12
Marketing end
2022-04-30
Active strength
0
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0603-75210603-7521-49DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
A076337-001CYCLAFEM 1/35ETHINYL ESTRADIOL; NORETHINDRONE0.035MG;1MGTABLET / ORAL-282010-11-12

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 22:38:342026-08A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-282010-11-1284e616aacf4f…
2026-08-18 06:07:402026-07A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-282010-11-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-282010-11-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-282010-11-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-282010-11-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-282010-11-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-282010-11-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-282010-11-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-282010-11-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-282010-11-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-282010-11-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-282010-11-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-282010-11-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-282010-11-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-282010-11-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-282010-11-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-282010-11-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-282010-11-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-282010-11-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-28AB2010-11-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-282010-11-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-282010-11-12782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-28AB2010-11-1287673890dc5c…
2021-03-12 10:30 UTC2021-03A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-28AB2010-11-125aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-28AB2010-11-128869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-28AB2010-11-12c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-28AB2010-11-123f01610625f2…
2019-09-15 20:21 UTC2019-09A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-28AB2010-11-12b00525d2431f…
2019-07-19 19:46 UTC2019-07A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-28AB2010-11-12ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-282010-11-126a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-282010-11-121c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-282010-11-12ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-282010-11-12a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-282010-11-129b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-282010-11-12a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-282010-11-123f0d92c62455…
2023-05-13 08:27 UTC2023-05A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-282010-11-12053a50430f4f…
2023-01-26 05:58 UTC2023-01A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-282010-11-123bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-282010-11-123a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076337-001CYCLAFEM 1/350.035MG;1MGTABLET / ORAL-282010-11-12f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A076337-001AB174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076337-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A076337-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076337-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076337-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076337-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076337-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076337-001AB1ea99ee380514…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
859c4b0b-8cba-4f41-9afe-cc181a01fb62Product name220240215
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
833edb59-a012-45c2-aff5-2ed74b66fa59Product name120201207
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
f4d31098-441e-52d3-27f1-49c829f8a3a1Product name520190703
6dd982ab-2966-22ee-3b75-d225abb791aaProduct name520190612
d2c4820a-bb24-f61d-8cd0-dd0290a6bd4dProduct name720190612
f92411e4-13dd-7baf-106e-9b3fcf758c39Product name420190502
c21bcd2e-ecbd-48e6-ab68-12cc12256c0fProduct name220190213
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
f6ac5560-6d3b-d281-41d2-adc50d283c20Product name320170228
120cc5ad-761c-444c-9e82-dec22f96dfe1Product name720161219
01996782-abcb-4e6d-bcaf-4a23e6a95c0cProduct name120160714
2aecf0b6-88a0-49e5-92e1-983c700c116cProduct name120151222
61972742-5d4d-491d-a881-b6bc3a011577Product name120151113
23ede539-308f-46e5-817b-41ef23af8d40Product name120150930
425e3610-bbe8-4d70-9c46-8cf09afc4e4dProduct name120150930
5e13e814-349e-3480-99f3-ee22a591426fProduct name220150518
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3Product name120140508
d0cc7d42-77a7-b452-c6c3-a162fa11225fProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0603-7521-01EA - Each0603-752191fc3d55-4cc2-44c0-ac34-3f206c62952312015-05-05
0603-7521-17EA - Each0603-75213ad688f4-734c-4aeb-ad21-82df52f6a57c12012-07-24
0603-7521-49EA - Each0603-7521bde89cca-26b9-4178-9277-bf6955e4573912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UCYCLAFEM 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]11
NORETHINDRONEACTIVE INGREDIENTT18F433X4SCYCLAFEM 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]11
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UCYCLAFEM 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]11
NORETHINDRONEACTIVE MOIETYT18F433X4SCYCLAFEM 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]11
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCYCLAFEM 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]11
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACYCLAFEM 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]11
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCYCLAFEM 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]11
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6CYCLAFEM 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]11
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCYCLAFEM 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYCLAFEM 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]11
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCYCLAFEM 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]11
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BCYCLAFEM 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]11
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCYCLAFEM 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1047040{21 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Cyclafem 1/35 28 Day]BPCKc91c8c31-4806-449e-bfe5-fa5c615252dc1
749858{21 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCKc91c8c31-4806-449e-bfe5-fa5c615252dc1
1047040Cyclafem 1/35 28 Day PackPSNc91c8c31-4806-449e-bfe5-fa5c615252dc1
749858Eth estra-Noreth 0.035-1 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSNc91c8c31-4806-449e-bfe5-fa5c615252dc1
748797inert 1 MG Oral TabletPSNc91c8c31-4806-449e-bfe5-fa5c615252dc1
312033norethindrone acetate 1 MG / ethinyl estradiol 35 MCG Oral TabletPSNc91c8c31-4806-449e-bfe5-fa5c615252dc1
312033ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral TabletSCDc91c8c31-4806-449e-bfe5-fa5c615252dc1
748797inert ingredients 1 MG Oral TabletSCDc91c8c31-4806-449e-bfe5-fa5c615252dc1
1047040Cyclafem 1/35 28 Day PackSYc91c8c31-4806-449e-bfe5-fa5c615252dc1
312033ethinyl estradiol 35 MCG / norethindrone 1 MG Oral TabletSYc91c8c31-4806-449e-bfe5-fa5c615252dc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0603-7521-49006037521493 BLISTER PACK in 1 CARTON (0603-7521-49) > 1 KIT in 1 BLISTER PACK (0603-7521-01) 3 blister pack2010-11-122022-04-30NoNoCurrent