Home NDC 72789-219-08 Nifedipine
Product NDC 72789-219
Requested package NDC 72789-219-08
11-digit product format 727890219
Labeler code 72789
Product ID 72789-219_5ec291a6-aacc-371f-e063-6294a90af853
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nifedipine
Dosage form CAPSULE
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA202644
Marketing category ANDA
Marketing start 2010-12-07
Substance NIFEDIPINE
Active strength 10 mg/1
Pharmacologic classes Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 45 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202644-001 NIFEDIPINE NIFEDIPINE 10MG CAPSULE / ORAL AB RS 2013-04-25 A202644-002 NIFEDIPINE NIFEDIPINE 20MG CAPSULE / ORAL AB 2013-04-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 90 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 2026-11-14 07:37:17 2026-10 A202644-001 NIFEDIPINE 10MG CAPSULE / ORAL AB RS 2013-04-25 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A202644-002 NIFEDIPINE 20MG CAPSULE / ORAL AB 2013-04-25 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A202644-001 NIFEDIPINE 10MG CAPSULE / ORAL AB RS 2013-04-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 A202644-002 NIFEDIPINE 20MG CAPSULE / ORAL AB 2013-04-25 c2088c7a36db…2026-09-14 22:38:34 2026-08 A202644-001 NIFEDIPINE 10MG CAPSULE / ORAL AB RS 2013-04-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202644-002 NIFEDIPINE 20MG CAPSULE / ORAL AB 2013-04-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202644-001 NIFEDIPINE 10MG CAPSULE / ORAL AB RS 2013-04-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202644-002 NIFEDIPINE 20MG CAPSULE / ORAL AB 2013-04-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202644-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 2013-04-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202644-002 NIFEDIPINE 20MG CAPSULE / ORAL AB 2013-04-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202644-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 2013-04-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202644-002 NIFEDIPINE 20MG CAPSULE / ORAL AB 2013-04-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202644-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 2013-04-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202644-002 NIFEDIPINE 20MG CAPSULE / ORAL AB 2013-04-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202644-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 2013-04-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202644-002 NIFEDIPINE 20MG CAPSULE / ORAL AB 2013-04-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202644-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 2013-04-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202644-002 NIFEDIPINE 20MG CAPSULE / ORAL AB 2013-04-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202644-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 2013-04-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202644-002 NIFEDIPINE 20MG CAPSULE / ORAL AB 2013-04-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202644-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 2013-04-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202644-002 NIFEDIPINE 20MG CAPSULE / ORAL AB 2013-04-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202644-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 2013-04-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202644-002 NIFEDIPINE 20MG CAPSULE / ORAL AB 2013-04-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202644-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 2013-04-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202644-002 NIFEDIPINE 20MG CAPSULE / ORAL AB 2013-04-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202644-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 2013-04-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202644-002 NIFEDIPINE 20MG CAPSULE / ORAL AB 2013-04-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202644-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 2013-04-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202644-002 NIFEDIPINE 20MG CAPSULE / ORAL AB 2013-04-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202644-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 2013-04-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202644-002 NIFEDIPINE 20MG CAPSULE / ORAL AB 2013-04-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202644-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 2013-04-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202644-002 NIFEDIPINE 20MG CAPSULE / ORAL AB 2013-04-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202644-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 2013-04-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202644-002 NIFEDIPINE 20MG CAPSULE / ORAL AB 2013-04-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202644-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 2013-04-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202644-002 NIFEDIPINE 20MG CAPSULE / ORAL AB 2013-04-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202644-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 2013-04-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A202644-002 NIFEDIPINE 20MG CAPSULE / ORAL AB 2013-04-25 5d02ea3f76ae…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 90 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 Nifedipine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NIFEDIPINE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination I9ZF7L6G2L Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198032 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 72789-219-08 Nifedipine 8 in 1 BOTTLE, PLASTIC CAPSULE 8 21
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72789-219 NIFEDIPINE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 20 Current NDC, Legacy NDC, 1 package rows 20240217_51cdb22b-035f-47d7-8048-38006e2589f2.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 · 5 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 72789-219-08 72789021908 8 CAPSULE in 1 BOTTLE, PLASTIC (72789-219-08) 8 capsule 2021-12-15 0000-00-00 No No Current