Home NDC 0555-9034 Balziva
Product NDC 0555-9034
11-digit product format 005559034
Labeler code 0555
Product ID 0555-9034_7885d65c-3e23-4a03-9d1b-132893517c04
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Norethindrone and Ethinyl Estradiol
Dosage form KIT
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA076238
Marketing category ANDA
Marketing start 2006-10-16
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076238-001 BALZIVA-28 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.4MG TABLET / ORAL-28 AB RS 2004-04-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076238-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A076238-001 BALZIVA-28 0.035MG;0.4MG TABLET / ORAL-28 AB RS 2004-04-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076238-001 BALZIVA-28 0.035MG;0.4MG TABLET / ORAL-28 AB RS 2004-04-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076238-001 BALZIVA-28 0.035MG;0.4MG TABLET / ORAL-28 AB RS 2004-04-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076238-001 BALZIVA-28 0.035MG;0.4MG TABLET / ORAL-28 AB RS 2004-04-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076238-001 BALZIVA-28 0.035MG;0.4MG TABLET / ORAL-28 AB RS 2004-04-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076238-001 BALZIVA-28 0.035MG;0.4MG TABLET / ORAL-28 AB RS 2004-04-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076238-001 BALZIVA-28 0.035MG;0.4MG TABLET / ORAL-28 AB RS 2004-04-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076238-001 BALZIVA-28 0.035MG;0.4MG TABLET / ORAL-28 AB RS 2004-04-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076238-001 BALZIVA-28 0.035MG;0.4MG TABLET / ORAL-28 AB RS 2004-04-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076238-001 BALZIVA-28 0.035MG;0.4MG TABLET / ORAL-28 AB RS 2004-04-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076238-001 BALZIVA-28 0.035MG;0.4MG TABLET / ORAL-28 AB RS 2004-04-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076238-001 BALZIVA-28 0.035MG;0.4MG TABLET / ORAL-28 AB RS 2004-04-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076238-001 BALZIVA-28 0.035MG;0.4MG TABLET / ORAL-28 AB RS 2004-04-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076238-001 BALZIVA-28 0.035MG;0.4MG TABLET / ORAL-28 AB RS 2004-04-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076238-001 BALZIVA-28 0.035MG;0.4MG TABLET / ORAL-28 AB RS 2004-04-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076238-001 BALZIVA-28 0.035MG;0.4MG TABLET / ORAL-28 AB RS 2004-04-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076238-001 BALZIVA-28 0.035MG;0.4MG TABLET / ORAL-28 AB RS 2004-04-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076238-001 BALZIVA-28 0.035MG;0.4MG TABLET / ORAL-28 AB RS 2004-04-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076238-001 BALZIVA-28 0.035MG;0.4MG TABLET / ORAL-28 AB RS 2004-04-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076238-001 BALZIVA-28 0.035MG;0.4MG TABLET / ORAL-28 AB RS 2004-04-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076238-001 BALZIVA-28 0.035MG;0.4MG TABLET / ORAL-28 AB RS 2004-04-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076238-001 BALZIVA-28 0.035MG;0.4MG TABLET / ORAL-28 AB RS 2004-04-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076238-001 BALZIVA-28 0.035MG;0.4MG TABLET / ORAL-28 AB RS 2004-04-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076238-001 BALZIVA-28 0.035MG;0.4MG TABLET / ORAL-28 AB RS 2004-04-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076238-001 BALZIVA-28 0.035MG;0.4MG TABLET / ORAL-28 AB RS 2004-04-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076238-001 BALZIVA-28 0.035MG;0.4MG TABLET / ORAL-28 AB RS 2004-04-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076238-001 BALZIVA-28 0.035MG;0.4MG TABLET / ORAL-28 AB RS 2004-04-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076238-001 BALZIVA-28 0.035MG;0.4MG TABLET / ORAL-28 AB RS 2004-04-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076238-001 BALZIVA-28 0.035MG;0.4MG TABLET / ORAL-28 AB RS 2004-04-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076238-001 BALZIVA-28 0.035MG;0.4MG TABLET / ORAL-28 AB RS 2004-04-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076238-001 BALZIVA-28 0.035MG;0.4MG TABLET / ORAL-28 AB RS 2004-04-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076238-001 BALZIVA-28 0.035MG;0.4MG TABLET / ORAL-28 AB RS 2004-04-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076238-001 BALZIVA-28 0.035MG;0.4MG TABLET / ORAL-28 AB RS 2004-04-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076238-001 BALZIVA-28 0.035MG;0.4MG TABLET / ORAL-28 AB RS 2004-04-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076238-001 BALZIVA-28 0.035MG;0.4MG TABLET / ORAL-28 AB RS 2004-04-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076238-001 BALZIVA-28 0.035MG;0.4MG TABLET / ORAL-28 AB RS 2004-04-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076238-001 BALZIVA-28 0.035MG;0.4MG TABLET / ORAL-28 AB RS 2004-04-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076238-001 BALZIVA-28 0.035MG;0.4MG TABLET / ORAL-28 AB RS 2004-04-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076238-001 BALZIVA-28 0.035MG;0.4MG TABLET / ORAL-28 AB RS 2004-04-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076238-001 BALZIVA-28 0.035MG;0.4MG TABLET / ORAL-28 AB RS 2004-04-22 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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 Balziva
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 238015 Internal RxNorm lookup 748797 Internal RxNorm lookup 749736 Internal RxNorm lookup 1095362 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0555-9034-58 Balziva 6 in 1 CARTON KIT 6 15 0555-9034-79 Balziva 1 in 1 BLISTER PACK KIT 1 15 0555-9034-79 Balziva 1 in 1 POUCH KIT 1 15
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0555-9034 BALZIVA (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [TEVA PHARMACEUTICALS USA, INC.] 14 Current NDC, Legacy NDC, 3 package rows 20221118_36a282d2-7285-442b-9574-dfce2d9456f1.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Balziva NORETHINDRONE AND ETHINYL ESTRADIOL Teva Pharmaceuticals USA, Inc. 36a282d2-7285-442b-9574-dfce2d9456f1 2021-12-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076238 application number: ANDA076238 ndc (product): 0555-9034
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0555-9034-58 00555903458 6 POUCH in 1 CARTON (0555-9034-58) / 1 BLISTER PACK in 1 POUCH (0555-9034-79) / 1 KIT in 1 BLISTER PACK 6 pouch 2006-10-16 0000-00-00 No No Current 0555-9034-79 00555903479 1 in 1 BLISTER PACK Historical