Home NDC 51862-884 CAMILA
Product NDC 51862-884
11-digit product format 518620884
Labeler code 51862
Product ID 51862-884_022c6de4-4589-4d4c-8ac4-977c7e3ef568
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name NORETHINDRONE
Dosage form TABLET
Route ORAL
Labeler Mayne Pharma Inc.
Application ANDA076177
Marketing category ANDA
Marketing start 2018-06-15
Substance NORETHINDRONE
Active strength .35 mg/1
Pharmacologic classes Progesterone Congeners [CS], Progestin [EPC]
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 A076177-001 CAMILA NORETHINDRONE 0.35MG TABLET / ORAL-28 AB1 2002-10-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076177-001 AB1
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 A076177-001 CAMILA 0.35MG TABLET / ORAL-28 AB1 2002-10-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076177-001 CAMILA 0.35MG TABLET / ORAL-28 AB1 2002-10-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076177-001 CAMILA 0.35MG TABLET / ORAL-28 AB1 2002-10-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076177-001 CAMILA 0.35MG TABLET / ORAL-28 AB1 2002-10-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076177-001 CAMILA 0.35MG TABLET / ORAL-28 AB1 2002-10-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076177-001 CAMILA 0.35MG TABLET / ORAL-28 AB1 2002-10-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076177-001 CAMILA 0.35MG TABLET / ORAL-28 AB1 2002-10-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076177-001 CAMILA 0.35MG TABLET / ORAL-28 AB1 2002-10-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076177-001 CAMILA 0.35MG TABLET / ORAL-28 AB1 2002-10-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076177-001 CAMILA 0.35MG TABLET / ORAL-28 AB1 2002-10-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076177-001 CAMILA 0.35MG TABLET / ORAL-28 AB1 2002-10-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076177-001 CAMILA 0.35MG TABLET / ORAL-28 AB1 2002-10-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076177-001 CAMILA 0.35MG TABLET / ORAL-28 AB1 2002-10-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076177-001 CAMILA 0.35MG TABLET / ORAL-28 AB1 2002-10-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076177-001 CAMILA 0.35MG TABLET / ORAL-28 AB1 2002-10-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076177-001 CAMILA 0.35MG TABLET / ORAL-28 AB1 2002-10-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076177-001 CAMILA 0.35MG TABLET / ORAL-28 AB1 2002-10-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076177-001 CAMILA 0.35MG TABLET / ORAL-28 AB1 2002-10-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076177-001 CAMILA 0.35MG TABLET / ORAL-28 AB1 2002-10-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076177-001 CAMILA 0.35MG TABLET / ORAL-28 AB1 2002-10-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076177-001 CAMILA 0.35MG TABLET / ORAL-28 AB1 2002-10-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076177-001 CAMILA 0.35MG TABLET / ORAL-28 AB1 2002-10-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076177-001 CAMILA 0.35MG TABLET / ORAL-28 AB1 2002-10-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076177-001 CAMILA 0.35MG TABLET / ORAL-28 AB1 2002-10-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076177-001 CAMILA 0.35MG TABLET / ORAL-28 AB1 2002-10-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076177-001 CAMILA 0.35MG TABLET / ORAL-28 AB1 2002-10-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076177-001 CAMILA 0.35MG TABLET / ORAL-28 AB1 2002-10-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076177-001 CAMILA 0.35MG TABLET / ORAL-28 AB1 2002-10-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076177-001 CAMILA 0.35MG TABLET / ORAL-28 AB1 2002-10-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076177-001 CAMILA 0.35MG TABLET / ORAL-28 AB1 2002-10-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076177-001 CAMILA 0.35MG TABLET / ORAL-28 AB1 2002-10-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076177-001 CAMILA 0.35MG TABLET / ORAL-28 AB1 2002-10-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076177-001 CAMILA 0.35MG TABLET / ORAL-28 AB1 2002-10-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076177-001 CAMILA 0.35MG TABLET / ORAL-28 AB1 2002-10-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076177-001 CAMILA 0.35MG TABLET / ORAL-28 AB1 2002-10-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076177-001 CAMILA 0.35MG TABLET / ORAL-28 AB1 2002-10-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076177-001 CAMILA 0.35MG TABLET / ORAL-28 AB1 2002-10-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076177-001 CAMILA 0.35MG TABLET / ORAL-28 AB1 2002-10-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076177-001 CAMILA 0.35MG TABLET / ORAL-28 AB1 2002-10-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076177-001 CAMILA 0.35MG TABLET / ORAL-28 AB1 2002-10-21 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51862-884-01 CAMILA 28 in 1 BLISTER PACK TABLET 28 2 51862-884-03 CAMILA 3 in 1 CARTON TABLET 3 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51862-884 CAMILA (NORETHINDRONE) TABLET [MAYNE PHARMA INC.] 2 Current NDC, Legacy NDC, 2 package rows 20180615_a786be85-49ba-4369-b510-7dccc10f7f18.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 CAMILA NORETHINDRONE Dr. Reddy's Labratories Inc. 59985565-af09-21ba-0336-3f6db7711bd1 2024-04-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 076177 application number: ANDA076177
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 51862-884-01 51862088401 28 in 1 BLISTER PACK Historical 51862-884-03 51862088403 3 BLISTER PACK in 1 CARTON (51862-884-03) / 28 TABLET in 1 BLISTER PACK (51862-884-01) 3 blister pack 2018-06-15 0000-00-00 No No Current