Home NDC 68083-136 Heparin Sodium
Product NDC 68083-136
11-digit product format 680830136
Labeler code 68083
Product ID 68083-136_7b0f85d1-774a-4644-af2f-c798d9c202a2
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 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 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 3 · 82 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 A205323-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2017-02-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205323-002 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2019-11-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A205323-001 HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE / INJECTION AP 2017-02-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205323-002 HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE / INJECTION AP 2019-11-18 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 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 Heparin Sodium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HEPARIN SODIUM 5000 [USP'U]/mL
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
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