Home NDC 63629-8358-1 Doxylamine succinate and pyridoxine hydrochloride
Product NDC 63629-8358
Requested package NDC 63629-8358-1
11-digit product format 636298358
Labeler code 63629
Product ID 63629-8358_cc9ee8eb-9955-40f4-bf93-112cc233deed
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxylamine succinate and pyridoxine hydrochloride
Dosage form TABLET, DELAYED RELEASE
Route ORAL
Labeler Bryant Ranch Prepack
Application NDA021876
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2018-11-15
Marketing end 0000-00-00
Substance DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
Active strength 10 mg/1; mg/1
Pharmacologic classes Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 12 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…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021876-001 DICLEGIS DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE 10MG;10MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2013-04-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021876-001 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 · 42 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 2026-08-18 06:07:40 2026-07 N021876-001 DICLEGIS 10MG;10MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2013-04-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021876-001 DICLEGIS 10MG;10MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2013-04-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021876-001 DICLEGIS 10MG;10MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2013-04-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021876-001 DICLEGIS 10MG;10MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2013-04-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021876-001 DICLEGIS 10MG;10MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2013-04-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021876-001 DICLEGIS 10MG;10MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2013-04-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021876-001 DICLEGIS 10MG;10MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2013-04-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021876-001 DICLEGIS 10MG;10MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2013-04-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021876-001 DICLEGIS 10MG;10MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2013-04-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021876-001 DICLEGIS 10MG;10MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2013-04-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021876-001 DICLEGIS 10MG;10MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2013-04-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021876-001 DICLEGIS 10MG;10MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2013-04-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021876-001 DICLEGIS 10MG;10MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2013-04-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021876-001 DICLEGIS 10MG;10MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2013-04-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021876-001 DICLEGIS 10MG;10MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2013-04-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021876-001 DICLEGIS 10MG;10MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2013-04-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021876-001 DICLEGIS 10MG;10MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2013-04-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021876-001 DICLEGIS 10MG;10MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2013-04-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021876-001 DICLEGIS 10MG;10MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2013-04-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021876-001 DICLEGIS 10MG;10MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2013-04-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021876-001 DICLEGIS 10MG;10MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2013-04-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021876-001 DICLEGIS 10MG;10MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2013-04-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021876-001 DICLEGIS 10MG;10MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2013-04-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021876-001 DICLEGIS 10MG;10MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2013-04-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021876-001 DICLEGIS 10MG;10MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2013-04-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021876-001 DICLEGIS 10MG;10MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2013-04-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021876-001 DICLEGIS 10MG;10MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2013-04-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021876-001 DICLEGIS 10MG;10MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2013-04-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021876-001 DICLEGIS 10MG;10MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2013-04-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021876-001 DICLEGIS 10MG;10MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2013-04-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021876-001 DICLEGIS 10MG;10MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2013-04-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021876-001 DICLEGIS 10MG;10MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2013-04-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021876-001 DICLEGIS 10MG;10MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2013-04-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021876-001 DICLEGIS 10MG;10MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2013-04-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021876-001 DICLEGIS 10MG;10MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2013-04-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021876-001 DICLEGIS 10MG;10MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2013-04-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021876-001 DICLEGIS 10MG;10MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2013-04-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021876-001 DICLEGIS 10MG;10MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2013-04-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021876-001 DICLEGIS 10MG;10MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2013-04-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021876-001 DICLEGIS 10MG;10MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2013-04-08 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021876-001 7560122 2019-01-25 Drug product 2013-04-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021876-001 6340695 2021-06-21 U-1382 Drug product 2013-04-16 74a2ff9319b5…2021-12-28 21:50 UTC 2021-12 N021876-001 6340695 2021-06-21 U-1382 Drug product 2013-04-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021876-001 6340695 2021-06-21 U-1382 Drug product 2013-04-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021876-001 6340695 2021-06-21 U-1382 Drug product 2013-04-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021876-001 6340695 2021-06-21 U-1382 Drug product 2013-04-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021876-001 6340695 2021-06-21 U-1382 Drug product 2013-04-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021876-001 7560122 2019-01-25 Drug product 2013-04-16 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021876-001 6340695 2021-06-21 U-1382 Drug product 2013-04-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021876-001 7560122 2019-01-25 Drug product 2013-04-16 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021876-001 6340695 2021-06-21 U-1382 Drug product 2013-04-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021876-001 7560122 2019-01-25 Drug product 2013-04-16 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021876-001 6340695 2021-06-21 U-1382 Drug product 2013-04-16 ea99ee380514…
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63629-8358-1 63629835801 30 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-8358-1) 2020-09-18 0000-00-00 No No Current