Home NDC 70954-076-10 Meloxicam
Product NDC 70954-076
Requested package NDC 70954-076-10
11-digit product format 709540076
Labeler code 70954
Product ID 70954-076_40db3e3d-d629-4943-98f1-dc2451013b6e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Meloxicam
Dosage form CAPSULE
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application ANDA211398
Marketing category ANDA
Marketing start 2021-03-10
Substance MELOXICAM
Active strength 5 mg/1
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
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 43 .
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 A211398-001 MELOXICAM MELOXICAM 5MG CAPSULE / ORAL AB 2021-03-09 A211398-002 MELOXICAM MELOXICAM 10MG CAPSULE / ORAL AB 2021-03-09
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 2 · 72 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 A211398-001 MELOXICAM 5MG CAPSULE / ORAL AB 2021-03-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211398-002 MELOXICAM 10MG CAPSULE / ORAL AB 2021-03-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211398-001 MELOXICAM 5MG CAPSULE / ORAL AB 2021-03-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211398-002 MELOXICAM 10MG CAPSULE / ORAL AB 2021-03-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211398-001 MELOXICAM 5MG CAPSULE / ORAL AB 2021-03-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211398-002 MELOXICAM 10MG CAPSULE / ORAL AB 2021-03-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211398-001 MELOXICAM 5MG CAPSULE / ORAL AB 2021-03-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211398-002 MELOXICAM 10MG CAPSULE / ORAL AB 2021-03-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211398-001 MELOXICAM 5MG CAPSULE / ORAL AB 2021-03-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211398-002 MELOXICAM 10MG CAPSULE / ORAL AB 2021-03-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211398-001 MELOXICAM 5MG CAPSULE / ORAL AB 2021-03-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211398-002 MELOXICAM 10MG CAPSULE / ORAL AB 2021-03-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211398-001 MELOXICAM 5MG CAPSULE / ORAL AB 2021-03-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211398-002 MELOXICAM 10MG CAPSULE / ORAL AB 2021-03-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211398-001 MELOXICAM 5MG CAPSULE / ORAL AB 2021-03-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211398-002 MELOXICAM 10MG CAPSULE / ORAL AB 2021-03-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211398-001 MELOXICAM 5MG CAPSULE / ORAL AB 2021-03-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211398-002 MELOXICAM 10MG CAPSULE / ORAL AB 2021-03-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211398-001 MELOXICAM 5MG CAPSULE / ORAL AB 2021-03-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211398-002 MELOXICAM 10MG CAPSULE / ORAL AB 2021-03-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211398-001 MELOXICAM 5MG CAPSULE / ORAL AB 2021-03-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211398-002 MELOXICAM 10MG CAPSULE / ORAL AB 2021-03-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211398-001 MELOXICAM 5MG CAPSULE / ORAL AB 2021-03-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211398-002 MELOXICAM 10MG CAPSULE / ORAL AB 2021-03-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211398-001 MELOXICAM 5MG CAPSULE / ORAL AB 2021-03-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211398-002 MELOXICAM 10MG CAPSULE / ORAL AB 2021-03-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211398-001 MELOXICAM 5MG CAPSULE / ORAL AB 2021-03-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211398-002 MELOXICAM 10MG CAPSULE / ORAL AB 2021-03-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211398-001 MELOXICAM 5MG CAPSULE / ORAL AB 2021-03-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211398-002 MELOXICAM 10MG CAPSULE / ORAL AB 2021-03-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211398-001 MELOXICAM 5MG CAPSULE / ORAL AB 2021-03-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A211398-002 MELOXICAM 10MG CAPSULE / ORAL AB 2021-03-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211398-001 MELOXICAM 5MG CAPSULE / ORAL AB 2021-03-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211398-002 MELOXICAM 10MG CAPSULE / ORAL AB 2021-03-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211398-001 MELOXICAM 5MG CAPSULE / ORAL AB 2021-03-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A211398-002 MELOXICAM 10MG CAPSULE / ORAL AB 2021-03-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211398-001 MELOXICAM 5MG CAPSULE / ORAL AB 2021-03-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A211398-002 MELOXICAM 10MG CAPSULE / ORAL AB 2021-03-09 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211398-001 MELOXICAM 5MG CAPSULE / ORAL AB 2021-03-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A211398-002 MELOXICAM 10MG CAPSULE / ORAL AB 2021-03-09 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 72 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 Meloxicam
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MELOXICAM 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination VG2QF83CGL Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1722349 Internal RxNorm lookup 1722357 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 70954-076-10 Meloxicam 30 in 1 BOTTLE CAPSULE 30 5 70954-076-20 Meloxicam 90 in 1 BOTTLE CAPSULE 90 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70954-076 MELOXICAM CAPSULE [ANI PHARMACEUTICALS, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20240727_ce9a8fd7-9bd2-4793-82f3-0fb8f0965d0f.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.
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 70954-076-10 70954007610 30 CAPSULE in 1 BOTTLE (70954-076-10) 30 capsule 2021-03-10 0000-00-00 No No Current