Home NDC 62332-966 PIVYA
Product NDC 62332-966
11-digit product format 623320966
Labeler code 62332
Product ID 62332-966_440a5eea-c5f5-4e61-e063-6294a90a3a0c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pivmecillinam
Dosage form TABLET, COATED
Route ORAL
Labeler Alembic Pharmaceuticals Inc.
Application NDA216483
Marketing category NDA
Marketing start 2026-02-02
Substance PIVMECILLINAM HYDROCHLORIDE
Active strength 185 mg/1
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 N216483-001 PIVYA PIVMECILLINAM HYDROCHLORIDE EQ 185MG BASE TABLET / ORAL RLD, RS 2024-04-24
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.
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 N216483-001 PIVYA EQ 185MG BASE TABLET / ORAL RLD, RS 2024-04-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216483-001 PIVYA EQ 185MG BASE TABLET / ORAL RLD, RS 2024-04-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216483-001 PIVYA EQ 185MG BASE TABLET / ORAL RLD, RS 2024-04-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216483-001 PIVYA EQ 185MG BASE TABLET / ORAL RLD, RS 2024-04-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216483-001 PIVYA EQ 185MG BASE TABLET / ORAL RLD, RS 2024-04-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216483-001 PIVYA EQ 185MG BASE TABLET / ORAL RLD, RS 2024-04-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216483-001 PIVYA EQ 185MG BASE TABLET / ORAL RLD, RS 2024-04-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216483-001 PIVYA EQ 185MG BASE TABLET / ORAL RLD, RS 2024-04-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216483-001 PIVYA EQ 185MG BASE TABLET / ORAL RLD 2024-04-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216483-001 PIVYA EQ 185MG BASE TABLET / ORAL RLD 2024-04-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216483-001 PIVYA EQ 185MG BASE TABLET / ORAL RLD 2024-04-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216483-001 PIVYA EQ 185MG BASE TABLET / ORAL RLD 2024-04-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216483-001 PIVYA EQ 185MG BASE TABLET / ORAL RLD, RS 2024-04-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216483-001 PIVYA EQ 185MG BASE TABLET / ORAL RLD, RS 2024-04-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216483-001 PIVYA EQ 185MG BASE TABLET / ORAL RLD, RS 2024-04-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N216483-001 PIVYA EQ 185MG BASE TABLET / ORAL RLD, RS 2024-04-24 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216483-001 PIVYA EQ 185MG BASE TABLET / ORAL RLD, RS 2024-04-24 a50c72e98297…
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 PIVYA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PIVMECILLINAM HYDROCHLORIDE 185 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 48FX7N21H2 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2715865 Internal RxNorm lookup 2715871 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 62332-966-09 PIVYA 9 in 1 BLISTER PACK TABLET, COATED 9 1 62332-966-09 PIVYA 1 in 1 CARTON TABLET, COATED 1 1 62332-966-10 PIVYA 5 in 1 CARTON TABLET, COATED 5 1 62332-966-10 PIVYA 10 in 1 BLISTER PACK TABLET, COATED 10 1
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 PIVYA PIVMECILLINAM Alembic Pharmaceuticals Inc. 440a5f17-ab11-0fc8-e063-6394a90a58e9 2025-10-10 Warnings, Adverse reactions Exact identifier application applno (NDA): 216483 application number: NDA216483 ndc (product): 62332-966
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 62332-966-09 62332096609 1 BLISTER PACK in 1 CARTON (62332-966-09) / 9 TABLET, COATED in 1 BLISTER PACK 1 blister pack 2026-02-02 No No Current 62332-966-10 62332096610 5 in 1 CARTON Historical