Home NDC 71288-404 Heparin Sodium
Product NDC 71288-404
11-digit product format 712880404
Labeler code 71288
Product ID 71288-404_505f018d-608d-4dd4-b7b9-640b25b0fc44
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Heparin Sodium
Dosage form INJECTION
Route INTRAVENOUS; SUBCUTANEOUS
Labeler Meitheal Pharmaceuticals Inc.
Application ANDA211007
Marketing category ANDA
Marketing start 2019-06-15
Substance HEPARIN SODIUM
Active strength 10000 [USP'U]/mL
Pharmacologic classes Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211007-001 HEPARIN SODIUM HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 A211007-002 HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 A211007-003 HEPARIN SODIUM HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 129 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 A211007-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211007-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211007-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211007-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211007-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211007-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211007-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211007-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211007-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211007-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211007-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211007-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211007-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211007-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211007-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211007-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211007-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211007-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211007-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211007-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211007-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211007-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211007-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211007-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211007-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211007-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211007-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211007-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211007-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211007-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211007-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211007-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211007-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211007-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211007-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211007-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211007-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211007-002 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211007-003 HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211007-001 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2019-05-28 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Heparin Sodium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HEPARIN SODIUM 10000 [USP'U]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination ZZ45AB24CA Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1361226 Internal RxNorm lookup 1361615 Internal RxNorm lookup 1362831 Internal RxNorm lookup 1658637 Internal RxNorm lookup 1658659 Internal RxNorm lookup 1659263 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 71288-404-01 Heparin Sodium 1 mL in 1 VIAL, SINGLE-DOSE INJECTION 1 12 71288-404-02 Heparin Sodium 25 in 1 CARTON INJECTION 25 12 71288-404-04 Heparin Sodium 4 mL in 1 VIAL, MULTI-DOSE INJECTION 4 12 71288-404-05 Heparin Sodium 25 in 1 CARTON INJECTION 25 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71288-404 HEPARIN SODIUM INJECTION [MEITHEAL PHARMACEUTICALS INC.] 11 Current NDC, Legacy NDC, 4 package rows 20250205_02fb700d-a28c-4d45-b78d-382dc0d5986c.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 · 4 matching rows.
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 1658637 heparin sodium, porcine 10,000 UNT in 1 ML Injection PSN 02fb700d-a28c-4d45-b78d-382dc0d5986c 12 1362831 heparin sodium, porcine 10,000 UNT/ML Injectable Solution PSN 02fb700d-a28c-4d45-b78d-382dc0d5986c 12 1658659 heparin sodium, porcine 1000 UNT in 1 ML Injection PSN 02fb700d-a28c-4d45-b78d-382dc0d5986c 12 1361226 heparin sodium, porcine 1000 UNT/ML Injectable Solution PSN 02fb700d-a28c-4d45-b78d-382dc0d5986c 12 1659263 heparin sodium, porcine 5000 UNT in 1 ML Injection PSN 02fb700d-a28c-4d45-b78d-382dc0d5986c 12 1361615 heparin sodium, porcine 5000 UNT/ML Injectable Solution PSN 02fb700d-a28c-4d45-b78d-382dc0d5986c 12 1658659 1 ML heparin sodium, porcine 1000 UNT/ML Injection SCD 02fb700d-a28c-4d45-b78d-382dc0d5986c 12 1658637 1 ML heparin sodium, porcine 10000 UNT/ML Injection SCD 02fb700d-a28c-4d45-b78d-382dc0d5986c 12 1659263 1 ML heparin sodium, porcine 5000 UNT/ML Injection SCD 02fb700d-a28c-4d45-b78d-382dc0d5986c 12 1361226 heparin sodium, porcine 1000 UNT/ML Injectable Solution SCD 02fb700d-a28c-4d45-b78d-382dc0d5986c 12 1362831 heparin sodium, porcine 10000 UNT/ML Injectable Solution SCD 02fb700d-a28c-4d45-b78d-382dc0d5986c 12 1361615 heparin sodium, porcine 5000 UNT/ML Injectable Solution SCD 02fb700d-a28c-4d45-b78d-382dc0d5986c 12 1658637 heparin sodium, porcine 10,000 UNT per 1 ML Injection SY 02fb700d-a28c-4d45-b78d-382dc0d5986c 12 1362831 heparin sodium, porcine 10,000 UNT/ML Injectable Solution SY 02fb700d-a28c-4d45-b78d-382dc0d5986c 12 1658659 heparin sodium, porcine 1000 UNT per 1 ML Injection SY 02fb700d-a28c-4d45-b78d-382dc0d5986c 12 1659263 heparin sodium, porcine 5000 UNT per 1 ML Injection SY 02fb700d-a28c-4d45-b78d-382dc0d5986c 12
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71288-404-01 71288040401 1 mL in 1 VIAL, SINGLE-DOSE 1 ml Historical 71288-404-02 71288040402 25 VIAL, SINGLE-DOSE in 1 CARTON (71288-404-02) / 1 mL in 1 VIAL, SINGLE-DOSE (71288-404-01) 2019-06-15 0000-00-00 No No Current 71288-404-04 71288040404 4 mL in 1 VIAL, MULTI-DOSE 4 ml Historical 71288-404-05 71288040405 25 VIAL, MULTI-DOSE in 1 CARTON (71288-404-05) / 4 mL in 1 VIAL, MULTI-DOSE (71288-404-04) 2019-06-15 0000-00-00 No No Current