Home NDC 68083-136 Heparin Sodium
Product NDC 68083-136
11-digit product format 680830136
Labeler code 68083
Product ID 68083-136_794ab494-666a-4e82-ba24-982189a20255
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Heparin Sodium
Dosage form INJECTION
Route INTRAVENOUS; SUBCUTANEOUS
Labeler Gland Pharma Limited
Application ANDA205323
Marketing category ANDA
Marketing start 2017-03-09
Substance HEPARIN SODIUM
Active strength 5000 [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 1 .
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 A205323-001 HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2017-02-06 A205323-002 HEPARIN SODIUM HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2019-11-18
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 · 78 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 2026-02-19 14:30 UTC 2026-02 A205323-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2017-02-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205323-002 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2019-11-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205323-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2017-02-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205323-002 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2019-11-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205323-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2017-02-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205323-002 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2019-11-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205323-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2017-02-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205323-002 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2019-11-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205323-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2017-02-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205323-002 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2019-11-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205323-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2017-02-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205323-002 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2019-11-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205323-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2017-02-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205323-002 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2019-11-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205323-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2017-02-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205323-002 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2019-11-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205323-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2017-02-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205323-002 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2019-11-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205323-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2017-02-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205323-002 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2019-11-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205323-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2017-02-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205323-002 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2019-11-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205323-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2017-02-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205323-002 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2019-11-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205323-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2017-02-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205323-002 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2019-11-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205323-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2017-02-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A205323-002 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2019-11-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205323-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2017-02-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205323-002 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2019-11-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205323-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2017-02-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A205323-002 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2019-11-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205323-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2017-02-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A205323-002 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2019-11-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205323-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2017-02-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205323-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2017-02-06 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A205323-002 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2019-11-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205323-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2017-02-06 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A205323-002 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2019-11-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205323-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2017-02-06 87673890dc5c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 78 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 5000 [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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1361226 Internal RxNorm lookup 1361615 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 68083-136-01 Heparin Sodium 1 mL in 1 VIAL INJECTION 1 12 68083-136-25 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 68083-136 HEPARIN SODIUM INJECTION [GLAND PHARMA LIMITED] 12 Current NDC, Legacy NDC, 2 package rows 20241119_301b19bc-21c2-4a35-9d29-569b08d855c4.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 68083-136-01 68083013601 1 mL in 1 VIAL 1 ml Historical 68083-136-25 68083013625 25 VIAL in 1 CARTON (68083-136-25) / 1 mL in 1 VIAL (68083-136-01) 25 vial 2017-03-09 0000-00-00 No No Current