FDA.reportPublic FDA data

Aurovela 24 Fe

Product NDC
65862-934
11-digit product format
658620934
Labeler code
65862
Product ID
65862-934_8b98eb73-94c9-43f2-bc65-de59a5ed1aed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate
Dosage form
KIT
Labeler
Aurobindo Pharma Limited
Application
ANDA207504
Marketing category
ANDA
Marketing start
2017-06-15
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 42.

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
A207504-001AUROVELA 24 FEETHINYL ESTRADIOL; NORETHINDRONE ACETATE0.02MG;1MGTABLET / ORALAB2017-06-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207504-001AB

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A207504-001AUROVELA 24 FE0.02MG;1MGTABLET / ORALAB2017-06-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207504-001AUROVELA 24 FE0.02MG;1MGTABLET / ORALAB2017-06-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207504-001AUROVELA 24 FE0.02MG;1MGTABLET / ORALAB2017-06-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A207504-001AUROVELA 24 FE0.02MG;1MGTABLET / ORALAB2017-06-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207504-001AUROVELA 24 FE0.02MG;1MGTABLET / ORALAB2017-06-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207504-001AUROVELA 24 FE0.02MG;1MGTABLET / ORALAB2017-06-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207504-001AUROVELA 24 FE0.02MG;1MGTABLET / ORALAB2017-06-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207504-001AUROVELA 24 FE0.02MG;1MGTABLET / ORALAB2017-06-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207504-001AUROVELA 24 FE0.02MG;1MGTABLET / ORALAB2017-06-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207504-001AUROVELA 24 FE0.02MG;1MGTABLET / ORALAB2017-06-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207504-001AUROVELA 24 FE0.02MG;1MGTABLET / ORALAB2017-06-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207504-001AUROVELA 24 FE0.02MG;1MGTABLET / ORALAB2017-06-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207504-001AUROVELA 24 FE0.02MG;1MGTABLET / ORALAB2017-06-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207504-001AUROVELA 24 FE0.02MG;1MGTABLET / ORALAB2017-06-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207504-001AUROVELA 24 FE0.02MG;1MGTABLET / ORALAB2017-06-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207504-001AUROVELA 24 FE0.02MG;1MGTABLET / ORALAB2017-06-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207504-001AUROVELA 24 FE0.02MG;1MGTABLET / ORALAB2017-06-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207504-001AUROVELA 24 FE0.02MG;1MGTABLET / ORALAB2017-06-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207504-001AUROVELA 24 FE0.02MG;1MGTABLET / ORALAB2017-06-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207504-001AUROVELA 24 FE0.02MG;1MGTABLET / ORALAB2017-06-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207504-001AUROVELA 24 FE0.02MG;1MGTABLET / ORALAB2017-06-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207504-001AUROVELA 24 FE0.02MG;1MGTABLET / ORALAB2017-06-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A207504-001AUROVELA 24 FE0.02MG;1MGTABLET / ORALAB2017-06-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207504-001AUROVELA 24 FE0.02MG;1MGTABLET / ORALAB2017-06-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207504-001AUROVELA 24 FE0.02MG;1MGTABLET / ORALAB2017-06-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207504-001AUROVELA 24 FE0.02MG;1MGTABLET / ORALAB2017-06-153f01610625f2…
2019-09-15 20:21 UTC2019-09A207504-001AUROVELA 24 FE0.02MG;1MGTABLET / ORALAB2017-06-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A207504-001AUROVELA 24 FE0.02MG;1MGTABLET / ORALAB2017-06-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207504-001AUROVELA 24 FE0.02MG;1MGTABLET / ORALAB2017-06-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207504-001AUROVELA 24 FE0.02MG;1MGTABLET / ORALAB2017-06-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207504-001AUROVELA 24 FE0.02MG;1MGTABLET / ORALAB2017-06-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207504-001AUROVELA 24 FE0.02MG;1MGTABLET / ORALAB2017-06-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207504-001AUROVELA 24 FE0.02MG;1MGTABLET / ORALAB2017-06-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207504-001AUROVELA 24 FE0.02MG;1MGTABLET / ORALAB2017-06-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207504-001AUROVELA 24 FE0.02MG;1MGTABLET / ORALAB2017-06-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A207504-001AUROVELA 24 FE0.02MG;1MGTABLET / ORALAB2017-06-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A207504-001AUROVELA 24 FE0.02MG;1MGTABLET / ORALAB2017-06-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207504-001AUROVELA 24 FE0.02MG;1MGTABLET / ORALAB2017-06-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207504-001AUROVELA 24 FE0.02MG;1MGTABLET / ORALAB2017-06-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207504-001AUROVELA 24 FE0.02MG;1MGTABLET / ORALAB2017-06-15e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A207504-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207504-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207504-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207504-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207504-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207504-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207504-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207504-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207504-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207504-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207504-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207504-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207504-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207504-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207504-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207504-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207504-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207504-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207504-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207504-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207504-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207504-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A207504-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207504-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207504-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207504-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A207504-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A207504-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207504-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207504-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207504-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207504-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207504-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207504-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207504-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A207504-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A207504-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207504-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207504-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207504-001AB1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Aurovela 24 Fe
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
259176Internal RxNorm lookup
1358762Internal RxNorm lookup
1359117Internal RxNorm lookup
1927957Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3eb092dc-2ec1-4d55-b1fe-69505608e04aAvailable 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
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-934-58Aurovela 24 Fe1 in 1 POUCHKIT114
65862-934-58Aurovela 24 Fe5 in 1 CARTONKIT514
65862-934-87Aurovela 24 Fe1 in 1 POUCHKIT114
65862-934-87Aurovela 24 Fe1 in 1 CARTONKIT114
65862-934-88Aurovela 24 Fe1 in 1 POUCHKIT114
65862-934-88Aurovela 24 Fe3 in 1 CARTONKIT314

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-934-87EA - Each65862-93411fa106c-aa62-4b18-b8bb-17e997a3065812019-05-02
65862-934-88EA - Each65862-934a2c70064-aea9-4f98-a9c2-e65abd7ca56a12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-934AUROVELA 24 FE (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [AUROBINDO PHARMA LIMITED]14Current NDC, Legacy NDC, 6 package rows20231123_3eb092dc-2ec1-4d55-b1fe-69505608e04a.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aurovela 24 FeNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEAurobindo Pharma Limited3eb092dc-2ec1-4d55-b1fe-69505608e04a2023-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207504
application number: ANDA207504
ndc (product): 65862-934
TARINA 24 FENORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEAfaxys Pharma, LLC557fa655-c40f-4ecb-bd18-4820c7e15e4b2023-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207504
application number: ANDA207504

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1927957{24 (ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Tablet) / 4 (ferrous fumarate 75 MG Oral Tablet) } Pack [Aurovela Fe 24 1/20 28 Day]BPCK3eb092dc-2ec1-4d55-b1fe-69505608e04a14
1359117{24 (ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Tablet) / 4 (ferrous fumarate 75 MG Oral Tablet) } PackGPCK3eb092dc-2ec1-4d55-b1fe-69505608e04a14
1927957Aurovela 24 Fe 1/20 28 Day PackPSN3eb092dc-2ec1-4d55-b1fe-69505608e04a14
1359117Eth estra-Noreth Ac 0.02-1 MG (24) Oral Tablet / Ferr fum 75 MG (4) Oral Tablet 28 Day PackPSN3eb092dc-2ec1-4d55-b1fe-69505608e04a14
259176ferrous fumarate 75 MG Oral TabletPSN3eb092dc-2ec1-4d55-b1fe-69505608e04a14
1358762norethindrone acetate 1 MG / ethinyl estradiol 0.02 MG Oral TabletPSN3eb092dc-2ec1-4d55-b1fe-69505608e04a14
1358762ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral TabletSCD3eb092dc-2ec1-4d55-b1fe-69505608e04a14
259176ferrous fumarate 75 MG Oral TabletSCD3eb092dc-2ec1-4d55-b1fe-69505608e04a14
1927957Aurovela 24 Fe 1/20 28 Day PackSY3eb092dc-2ec1-4d55-b1fe-69505608e04a14
1359117ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Tablet / ferrous fumarate 75 MG Oral Tablet 28 day PackSY3eb092dc-2ec1-4d55-b1fe-69505608e04a14
1358762ethinyl estradiol 20 MCG / norethindrone acetate 1 MG Oral TabletSY3eb092dc-2ec1-4d55-b1fe-69505608e04a14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-934-58658620934585 POUCH in 1 CARTON (65862-934-58) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK5 pouch2017-06-150000-00-00NoNoCurrent
65862-934-87658620934871 POUCH in 1 CARTON (65862-934-87) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK1 pouch2017-06-150000-00-00NoNoCurrent
65862-934-88658620934883 POUCH in 1 CARTON (65862-934-88) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK3 pouch2017-06-150000-00-00NoNoCurrent