Home NDC 70934-164-20 Cefdinir
Product NDC 70934-164
Requested package NDC 70934-164-20
11-digit product format 709340164
Labeler code 70934
Product ID 70934-164_b816046d-d447-5ba9-e053-2a95a90ace48
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefdinir
Dosage form CAPSULE
Route ORAL
Labeler Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application ANDA065330
Marketing category ANDA
Marketing start 2018-09-10
Marketing end 0000-00-00
Substance CEFDINIR
Active strength 300 mg/1
Pharmacologic classes Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A065330-001 CEFDINIR CEFDINIR 300MG CAPSULE / ORAL AB RS 2007-04-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065330-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A065330-001 CEFDINIR 300MG CAPSULE / ORAL AB RS 2007-04-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065330-001 CEFDINIR 300MG CAPSULE / ORAL AB RS 2007-04-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065330-001 CEFDINIR 300MG CAPSULE / ORAL AB RS 2007-04-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065330-001 CEFDINIR 300MG CAPSULE / ORAL AB RS 2007-04-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065330-001 CEFDINIR 300MG CAPSULE / ORAL AB RS 2007-04-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065330-001 CEFDINIR 300MG CAPSULE / ORAL AB RS 2007-04-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065330-001 CEFDINIR 300MG CAPSULE / ORAL AB RS 2007-04-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065330-001 CEFDINIR 300MG CAPSULE / ORAL AB RS 2007-04-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065330-001 CEFDINIR 300MG CAPSULE / ORAL AB RS 2007-04-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065330-001 CEFDINIR 300MG CAPSULE / ORAL AB RS 2007-04-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065330-001 CEFDINIR 300MG CAPSULE / ORAL AB RS 2007-04-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065330-001 CEFDINIR 300MG CAPSULE / ORAL AB RS 2007-04-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065330-001 CEFDINIR 300MG CAPSULE / ORAL AB RS 2007-04-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065330-001 CEFDINIR 300MG CAPSULE / ORAL AB RS 2007-04-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065330-001 CEFDINIR 300MG CAPSULE / ORAL AB RS 2007-04-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065330-001 CEFDINIR 300MG CAPSULE / ORAL AB RS 2007-04-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065330-001 CEFDINIR 300MG CAPSULE / ORAL AB RS 2007-04-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065330-001 CEFDINIR 300MG CAPSULE / ORAL AB RS 2007-04-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065330-001 CEFDINIR 300MG CAPSULE / ORAL AB RS 2007-04-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065330-001 CEFDINIR 300MG CAPSULE / ORAL AB RS 2007-04-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065330-001 CEFDINIR 300MG CAPSULE / ORAL AB RS 2007-04-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065330-001 CEFDINIR 300MG CAPSULE / ORAL AB RS 2007-04-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065330-001 CEFDINIR 300MG CAPSULE / ORAL AB RS 2007-04-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065330-001 CEFDINIR 300MG CAPSULE / ORAL AB RS 2007-04-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065330-001 CEFDINIR 300MG CAPSULE / ORAL AB RS 2007-04-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065330-001 CEFDINIR 300MG CAPSULE / ORAL AB RS 2007-04-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065330-001 CEFDINIR 300MG CAPSULE / ORAL AB RS 2007-04-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065330-001 CEFDINIR 300MG CAPSULE / ORAL AB RS 2007-04-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065330-001 CEFDINIR 300MG CAPSULE / ORAL AB RS 2007-04-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065330-001 CEFDINIR 300MG CAPSULE / ORAL AB RS 2007-04-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065330-001 CEFDINIR 300MG CAPSULE / ORAL AB RS 2007-04-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065330-001 CEFDINIR 300MG CAPSULE / ORAL AB RS 2007-04-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065330-001 CEFDINIR 300MG CAPSULE / ORAL AB RS 2007-04-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065330-001 CEFDINIR 300MG CAPSULE / ORAL AB RS 2007-04-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065330-001 CEFDINIR 300MG CAPSULE / ORAL AB RS 2007-04-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065330-001 CEFDINIR 300MG CAPSULE / ORAL AB RS 2007-04-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065330-001 CEFDINIR 300MG CAPSULE / ORAL AB RS 2007-04-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065330-001 CEFDINIR 300MG CAPSULE / ORAL AB RS 2007-04-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065330-001 CEFDINIR 300MG CAPSULE / ORAL AB RS 2007-04-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A065330-001 CEFDINIR 300MG CAPSULE / ORAL AB RS 2007-04-06 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70934-164-20 Cefdinir 20 in 1 BOTTLE, PLASTIC CAPSULE 20 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70934-164 CEFDINIR CAPSULE [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS] 3 Legacy NDC, 1 package rows 20210112_76a31bff-99f3-e0d5-e053-2991aa0a00fa.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.
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 70934-164-20 70934016420 20 CAPSULE in 1 BOTTLE, PLASTIC (70934-164-20) 20 capsule 2018-09-10 0000-00-00 No No Current