Home NDC 0409-7620 Heparin Sodium
Product NDC 0409-7620
11-digit product format 004097620
Labeler code 0409
Product ID 0409-7620_9efb32ae-3ffe-4a82-8719-43762f675d8d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name HEPARIN SODIUM
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hospira, Inc.
Application NDA018916
Marketing category NDA
Marketing start 2005-03-31
Marketing end 0000-00-00
Substance HEPARIN SODIUM
Active strength 200 [USP'U]/100mL
Pharmacologic classes Anti-coagulant [EPC],Heparin [CS],Unfractionated Heparin [EPC]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 11 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018916-001 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% HEPARIN SODIUM 1,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 N018916-002 HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9% HEPARIN SODIUM 10,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 N018916-003 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9% HEPARIN SODIUM 5,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 N018916-004 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45% HEPARIN SODIUM 100 UNITS/ML INJECTABLE / INJECTION 1984-01-31 N018916-005 HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45% HEPARIN SODIUM 10,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 N018916-006 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER HEPARIN SODIUM 5,000 UNITS/100ML INJECTABLE / INJECTION RLD, RS 1984-01-31 N018916-007 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER HEPARIN SODIUM 5,000 UNITS/100ML INJECTABLE / INJECTION RLD, RS 1984-01-31 N018916-008 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER HEPARIN SODIUM 10,000 UNITS/100ML INJECTABLE / INJECTION RLD, RS 1984-01-31 N018916-009 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM 5,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 N018916-010 HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM 200 UNITS/100ML INJECTABLE / INJECTION AP RLD, RS 1989-06-23 N018916-011 HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM 200 UNITS/100ML INJECTABLE / INJECTION AP RLD, RS 1989-06-23
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 13 · 484 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 2026-10-15 13:18:30 2026-09 N018916-001 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% 1,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N018916-002 HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9% 10,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N018916-003 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9% 5,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N018916-004 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45% 100 UNITS/ML INJECTABLE / INJECTION 1984-01-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N018916-005 HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45% 10,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N018916-006 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 5,000 UNITS/100ML INJECTABLE / INJECTION RLD, RS 1984-01-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N018916-007 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 5,000 UNITS/100ML INJECTABLE / INJECTION RLD, RS 1984-01-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N018916-008 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 10,000 UNITS/100ML INJECTABLE / INJECTION RLD, RS 1984-01-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N018916-009 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 5,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N018916-010 HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200 UNITS/100ML INJECTABLE / INJECTION AP RLD, RS 1989-06-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 N018916-011 HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200 UNITS/100ML INJECTABLE / INJECTION AP RLD, RS 1989-06-23 c2088c7a36db…2026-09-14 22:38:34 2026-08 N018916-001 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% 1,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018916-002 HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9% 10,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018916-003 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9% 5,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018916-004 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45% 100 UNITS/ML INJECTABLE / INJECTION 1984-01-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018916-005 HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45% 10,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018916-006 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 5,000 UNITS/100ML INJECTABLE / INJECTION RLD, RS 1984-01-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018916-007 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 5,000 UNITS/100ML INJECTABLE / INJECTION RLD, RS 1984-01-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018916-008 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 10,000 UNITS/100ML INJECTABLE / INJECTION RLD, RS 1984-01-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018916-009 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 5,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018916-010 HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200 UNITS/100ML INJECTABLE / INJECTION AP RLD, RS 1989-06-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018916-011 HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200 UNITS/100ML INJECTABLE / INJECTION AP RLD, RS 1989-06-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 N018916-001 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% 1,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018916-002 HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9% 10,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018916-003 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9% 5,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018916-004 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45% 100 UNITS/ML INJECTABLE / INJECTION 1984-01-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018916-005 HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45% 10,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018916-006 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 5,000 UNITS/100ML INJECTABLE / INJECTION RLD, RS 1984-01-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018916-007 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 5,000 UNITS/100ML INJECTABLE / INJECTION RLD, RS 1984-01-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018916-008 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 10,000 UNITS/100ML INJECTABLE / INJECTION RLD, RS 1984-01-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018916-009 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 5,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018916-010 HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200 UNITS/100ML INJECTABLE / INJECTION AP RLD, RS 1989-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018916-011 HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200 UNITS/100ML INJECTABLE / INJECTION AP RLD, RS 1989-06-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N018916-001 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% 1,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018916-002 HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9% 10,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018916-003 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9% 5,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018916-004 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45% 100 UNITS/ML INJECTABLE / INJECTION 1984-01-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018916-005 HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45% 10,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018916-006 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 5,000 UNITS/100ML INJECTABLE / INJECTION RLD, RS 1984-01-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018916-007 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 5,000 UNITS/100ML INJECTABLE / INJECTION RLD, RS 1984-01-31 011fe1cb6892…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 3 · 88 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0409-7620-03 Heparin Sodium 1 in 1 POUCH INJECTION, SOLUTION 1 34 0409-7620-03 Heparin Sodium 18 in 1 CASE INJECTION, SOLUTION 18 34 0409-7620-13 Heparin Sodium 500 mL in 1 BAG INJECTION, SOLUTION 500 34 0409-7620-49 Heparin Sodium 1000 mL in 1 BAG INJECTION, SOLUTION 1000 34 0409-7620-59 Heparin Sodium 12 in 1 CASE INJECTION, SOLUTION 12 34 0409-7620-59 Heparin Sodium 1 in 1 POUCH INJECTION, SOLUTION 1 34
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HEPARIN SODIUM ACTIVE INGREDIENT ZZ45AB24CA HEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.] 15 HEPARIN ACTIVE MOIETY T2410KM04A HEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.] 15 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP HEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.] 15 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X HEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.] 15 SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE INACTIVE INGREDIENT 70WT22SF4B HEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.] 15 WATER INACTIVE INGREDIENT 059QF0KO0R HEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.] 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-7620 HEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.] 31 Legacy NDC, 6 package rows 20241127_32e34077-aff1-4ec7-f9b0-b8e240768fb8.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 · 3 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 0409-7620-03 00409762003 18 POUCH in 1 CASE (0409-7620-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG (0409-7620-13) 18 pouch 2005-03-31 0000-00-00 No No Current 0409-7620-13 00409762013 500 mL in 1 BAG 500 ml Historical 0409-7620-49 00409762049 1000 mL in 1 BAG 1000 ml Historical 0409-7620-59 00409762059 12 POUCH in 1 CASE (0409-7620-59) > 1 BAG in 1 POUCH > 1000 mL in 1 BAG (0409-7620-49) 12 pouch 2005-03-31 0000-00-00 No No Current