Home NDC 76282-271 Ramipril
Product NDC 76282-271
11-digit product format 762820271
Labeler code 76282
Product ID 76282-271_af09ebd5-6988-4e8c-b9b1-8e5e9c9520e3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ramipril
Dosage form CAPSULE
Route ORAL
Labeler Exelan Pharmaceuticals, Inc.
Application ANDA078745
Marketing category ANDA
Marketing start 2008-06-27
Marketing end 0000-00-00
Substance RAMIPRIL
Active strength 1 mg/1
Pharmacologic classes Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag E
Listing certified through 2018-12-31
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 2 · 88 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078745-001 RAMIPRIL RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 A078745-002 RAMIPRIL RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 A078745-003 RAMIPRIL RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 A078745-004 RAMIPRIL RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 5 · 172 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 A078745-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078745-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078745-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078745-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078745-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078745-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078745-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078745-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078745-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078745-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078745-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078745-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078745-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078745-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078745-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078745-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078745-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078745-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078745-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078745-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078745-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078745-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078745-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078745-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078745-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078745-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078745-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078745-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078745-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078745-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078745-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078745-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078745-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078745-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078745-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078745-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078745-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078745-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078745-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078745-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 3 of 5 · 172 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 76282-271-01 Ramipril 100 in 1 BOTTLE CAPSULE 100 3 76282-271-05 Ramipril 500 in 1 BOTTLE CAPSULE 500 3 76282-271-10 Ramipril 1000 in 1 BOTTLE CAPSULE 1000 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded RAMIPRIL ACTIVE INGREDIENT L35JN3I7SJ RAMIPRIL CAPSULE [EXELAN PHARMACEUTICALS, INC.] 1 RAMIPRIL ACTIVE MOIETY L35JN3I7SJ RAMIPRIL CAPSULE [EXELAN PHARMACEUTICALS, INC.] 1 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH RAMIPRIL CAPSULE [EXELAN PHARMACEUTICALS, INC.] 1 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L RAMIPRIL CAPSULE [EXELAN PHARMACEUTICALS, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G RAMIPRIL CAPSULE [EXELAN PHARMACEUTICALS, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD RAMIPRIL CAPSULE [EXELAN PHARMACEUTICALS, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA RAMIPRIL CAPSULE [EXELAN PHARMACEUTICALS, INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 RAMIPRIL CAPSULE [EXELAN PHARMACEUTICALS, INC.] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 RAMIPRIL CAPSULE [EXELAN PHARMACEUTICALS, INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L RAMIPRIL CAPSULE [EXELAN PHARMACEUTICALS, INC.] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O RAMIPRIL CAPSULE [EXELAN PHARMACEUTICALS, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ RAMIPRIL CAPSULE [EXELAN PHARMACEUTICALS, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RAMIPRIL CAPSULE [EXELAN PHARMACEUTICALS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76282-271 RAMIPRIL CAPSULE [EXELAN PHARMACEUTICALS, INC.] 3 Legacy NDC, 3 package rows 20171130_2e6303e8-1c22-451f-8733-a55e237ff961.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ramipril RAMIPRIL Chartwell RX, LLC. b7e49f05-6d4f-465a-b0d7-f704466a2e52 2026-01-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078745 application number: ANDA078745
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 76282-271-01 76282027101 100 in 1 BOTTLE Historical 76282-271-05 76282027105 500 in 1 BOTTLE Historical 76282-271-10 76282027110 1000 in 1 BOTTLE Historical