Home NDC 63629-9863-3 Cevimeline Hydrochloride
Product NDC 63629-9863
Requested package NDC 63629-9863-3
11-digit product format 636299863
Labeler code 63629
Product ID 63629-9863_b8a8d949-15e3-4dc7-afd2-c9621a5c7c83
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cevimeline Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA203775
Marketing category ANDA
Marketing start 2014-06-17
Substance CEVIMELINE HYDROCHLORIDE
Active strength 30 mg/1
Pharmacologic classes Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [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 A203775-001 CEVIMELINE HYDROCHLORIDE CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2014-06-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203775-001 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 A203775-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2014-06-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203775-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2014-06-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203775-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2014-06-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203775-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2014-06-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203775-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2014-06-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203775-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2014-06-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203775-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2014-06-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203775-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2014-06-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203775-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2014-06-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203775-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2014-06-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203775-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2014-06-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203775-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2014-06-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203775-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2014-06-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203775-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2014-06-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203775-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2014-06-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203775-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2014-06-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203775-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2014-06-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203775-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2014-06-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203775-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2014-06-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203775-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2014-06-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203775-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2014-06-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203775-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2014-06-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203775-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2014-06-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203775-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2014-06-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203775-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2014-06-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203775-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2014-06-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203775-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2014-06-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203775-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2014-06-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203775-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2014-06-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203775-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2014-06-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203775-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2014-06-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203775-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2014-06-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203775-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2014-06-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203775-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2014-06-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203775-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2014-06-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203775-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2014-06-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203775-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2014-06-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203775-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2014-06-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203775-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2014-06-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203775-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2014-06-04 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 Cevimeline Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEVIMELINE HYDROCHLORIDE 30 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination P81Q6V85NP Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309140 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 63629-9863-1 Cevimeline Hydrochloride 30 in 1 BOTTLE CAPSULE 30 101 63629-9863-2 Cevimeline Hydrochloride 60 in 1 BOTTLE CAPSULE 60 101 63629-9863-3 Cevimeline Hydrochloride 90 in 1 BOTTLE CAPSULE 90 101
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-9863 CEVIMELINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK] 101 Current NDC, 3 package rows 20240913_51307f82-66f2-41c7-80ff-174d7e50f7ee.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 63629-9863-3 63629986303 90 CAPSULE in 1 BOTTLE (63629-9863-3) 90 capsule 2024-09-05 No No Current