Fragmin

Product NDC: 0069-0196
11-digit product format: 000690196
Labeler code: 0069
Product ID: 0069-0196_af340f13-7954-4974-845d-ae55e0b56512
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dalteparin Sodium
Dosage form: INJECTION
Route: SUBCUTANEOUS
Labeler: Pfizer Laboratories Div Pfizer Inc
Application: NDA020287
Marketing category: NDA
Marketing start: 2015-04-01
Substance: DALTEPARIN SODIUM
Active strength: 5000 [iU]/.2mL
Pharmacologic classes: Anti-coagulant [EPC], Heparin, Low-Molecular-Weight [CS], Low Molecular Weight 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 · 12 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N020287-001	FRAGMIN	DALTEPARIN SODIUM	2,500IU/0.2ML (12,500IU/ML)	INJECTABLE / SUBCUTANEOUS	RLD	1994-12-22
N020287-002	FRAGMIN	DALTEPARIN SODIUM	10,000IU/0.4ML (25,000IU/ML)	INJECTABLE / SUBCUTANEOUS		2007-05-01
N020287-003	FRAGMIN	DALTEPARIN SODIUM	5,000IU/0.2ML (25,000IU/ML)	INJECTABLE / SUBCUTANEOUS	RLD	1996-03-18
N020287-004	FRAGMIN	DALTEPARIN SODIUM	10,000IU/ML (10,000IU/ML)	INJECTABLE / SUBCUTANEOUS	RLD	1998-01-30
N020287-005	FRAGMIN	DALTEPARIN SODIUM	7,500IU/0.3ML (25,000IU/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2002-04-04
N020287-006	FRAGMIN	DALTEPARIN SODIUM	95,000IU/3.8ML (25,000IU/ML)	INJECTABLE / SUBCUTANEOUS	RLD, RS	2002-04-04
N020287-007	FRAGMIN	DALTEPARIN SODIUM	95,000IU/9.5ML (10,000IU/ML)	INJECTABLE / SUBCUTANEOUS		2002-04-04
N020287-008	FRAGMIN	DALTEPARIN SODIUM	7,500 IU/0.75ML	INJECTABLE / INJECTION		2002-04-04
N020287-009	FRAGMIN	DALTEPARIN SODIUM	12,500IU/0.5ML (25,000IU/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2007-05-01
N020287-010	FRAGMIN	DALTEPARIN SODIUM	15,000IU/0.6ML (25,000IU/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2007-05-01
N020287-011	FRAGMIN	DALTEPARIN SODIUM	18,000IU/0.72ML (25,000IU/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2007-05-01
N020287-012	FRAGMIN	DALTEPARIN SODIUM	10,000IU/4ML (2,500IU/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2022-03-15

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 · 505 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020287-001	FRAGMIN	2,500IU/0.2ML (12,500IU/ML)	INJECTABLE / SUBCUTANEOUS	RLD	1994-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020287-002	FRAGMIN	10,000IU/0.4ML (25,000IU/ML)	INJECTABLE / SUBCUTANEOUS		2007-05-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020287-003	FRAGMIN	5,000IU/0.2ML (25,000IU/ML)	INJECTABLE / SUBCUTANEOUS	RLD	1996-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020287-004	FRAGMIN	10,000IU/ML (10,000IU/ML)	INJECTABLE / SUBCUTANEOUS	RLD	1998-01-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020287-005	FRAGMIN	7,500IU/0.3ML (25,000IU/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2002-04-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020287-006	FRAGMIN	95,000IU/3.8ML (25,000IU/ML)	INJECTABLE / SUBCUTANEOUS	RLD, RS	2002-04-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020287-007	FRAGMIN	95,000IU/9.5ML (10,000IU/ML)	INJECTABLE / SUBCUTANEOUS		2002-04-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020287-008	FRAGMIN	7,500 IU/0.75ML	INJECTABLE / INJECTION		2002-04-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020287-009	FRAGMIN	12,500IU/0.5ML (25,000IU/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2007-05-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020287-010	FRAGMIN	15,000IU/0.6ML (25,000IU/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2007-05-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020287-011	FRAGMIN	18,000IU/0.72ML (25,000IU/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2007-05-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020287-012	FRAGMIN	10,000IU/4ML (2,500IU/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2022-03-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020287-001	FRAGMIN	2,500IU/0.2ML (12,500IU/ML)	INJECTABLE / SUBCUTANEOUS	RLD	1994-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020287-002	FRAGMIN	10,000IU/0.4ML (25,000IU/ML)	INJECTABLE / SUBCUTANEOUS		2007-05-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020287-003	FRAGMIN	5,000IU/0.2ML (25,000IU/ML)	INJECTABLE / SUBCUTANEOUS	RLD	1996-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020287-004	FRAGMIN	10,000IU/ML (10,000IU/ML)	INJECTABLE / SUBCUTANEOUS	RLD	1998-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020287-005	FRAGMIN	7,500IU/0.3ML (25,000IU/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2002-04-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020287-006	FRAGMIN	95,000IU/3.8ML (25,000IU/ML)	INJECTABLE / SUBCUTANEOUS	RLD, RS	2002-04-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020287-007	FRAGMIN	95,000IU/9.5ML (10,000IU/ML)	INJECTABLE / SUBCUTANEOUS		2002-04-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020287-008	FRAGMIN	7,500 IU/0.75ML	INJECTABLE / INJECTION		2002-04-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020287-009	FRAGMIN	12,500IU/0.5ML (25,000IU/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2007-05-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020287-010	FRAGMIN	15,000IU/0.6ML (25,000IU/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2007-05-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020287-011	FRAGMIN	18,000IU/0.72ML (25,000IU/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2007-05-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020287-012	FRAGMIN	10,000IU/4ML (2,500IU/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2022-03-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020287-001	FRAGMIN	2,500IU/0.2ML (12,500IU/ML)	INJECTABLE / SUBCUTANEOUS	RLD	1994-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020287-002	FRAGMIN	10,000IU/0.4ML (25,000IU/ML)	INJECTABLE / SUBCUTANEOUS		2007-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020287-003	FRAGMIN	5,000IU/0.2ML (25,000IU/ML)	INJECTABLE / SUBCUTANEOUS	RLD	1996-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020287-004	FRAGMIN	10,000IU/ML (10,000IU/ML)	INJECTABLE / SUBCUTANEOUS	RLD	1998-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020287-005	FRAGMIN	7,500IU/0.3ML (25,000IU/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2002-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020287-006	FRAGMIN	95,000IU/3.8ML (25,000IU/ML)	INJECTABLE / SUBCUTANEOUS	RLD, RS	2002-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020287-007	FRAGMIN	95,000IU/9.5ML (10,000IU/ML)	INJECTABLE / SUBCUTANEOUS		2002-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020287-008	FRAGMIN	7,500 IU/0.75ML	INJECTABLE / INJECTION		2002-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020287-009	FRAGMIN	12,500IU/0.5ML (25,000IU/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2007-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020287-010	FRAGMIN	15,000IU/0.6ML (25,000IU/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2007-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020287-011	FRAGMIN	18,000IU/0.72ML (25,000IU/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2007-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020287-012	FRAGMIN	10,000IU/4ML (2,500IU/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2022-03-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020287-001	FRAGMIN	2,500IU/0.2ML (12,500IU/ML)	INJECTABLE / SUBCUTANEOUS	RLD	1994-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020287-002	FRAGMIN	10,000IU/0.4ML (25,000IU/ML)	INJECTABLE / SUBCUTANEOUS		2007-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020287-003	FRAGMIN	5,000IU/0.2ML (25,000IU/ML)	INJECTABLE / SUBCUTANEOUS	RLD	1996-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020287-004	FRAGMIN	10,000IU/ML (10,000IU/ML)	INJECTABLE / SUBCUTANEOUS	RLD	1998-01-30	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 5 · 193 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020287-001	NPP	2022-05-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020287-002	NPP	2022-05-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020287-003	NPP	2022-05-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020287-004	NPP	2022-05-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020287-005	NPP	2022-05-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020287-006	NPP	2022-05-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020287-007	NPP	2022-05-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020287-008	NPP	2022-05-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020287-009	NPP	2022-05-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020287-010	NPP	2022-05-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020287-011	NPP	2022-05-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020287-001	NPP	2022-05-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020287-002	NPP	2022-05-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020287-003	NPP	2022-05-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020287-004	NPP	2022-05-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020287-005	NPP	2022-05-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020287-006	NPP	2022-05-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020287-007	NPP	2022-05-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020287-008	NPP	2022-05-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020287-009	NPP	2022-05-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020287-010	NPP	2022-05-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020287-011	NPP	2022-05-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020287-001	NPP	2022-05-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020287-002	NPP	2022-05-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020287-003	NPP	2022-05-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020287-004	NPP	2022-05-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020287-005	NPP	2022-05-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020287-006	NPP	2022-05-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020287-007	NPP	2022-05-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020287-008	NPP	2022-05-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020287-009	NPP	2022-05-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020287-010	NPP	2022-05-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020287-011	NPP	2022-05-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020287-001	NPP	2022-05-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020287-002	NPP	2022-05-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020287-003	NPP	2022-05-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020287-004	NPP	2022-05-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020287-005	NPP	2022-05-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020287-006	NPP	2022-05-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020287-007	NPP	2022-05-16	`74a2ff9319b5…`

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: Fragmin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DALTEPARIN SODIUM	5000 [iU]/.2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
12M44VTJ7B	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 18 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
978725	Internal RxNorm lookup
978727	Internal RxNorm lookup
978733	Internal RxNorm lookup
978735	Internal RxNorm lookup
978736	Internal RxNorm lookup
978737	Internal RxNorm lookup
978740	Internal RxNorm lookup
978741	Internal RxNorm lookup
978744	Internal RxNorm lookup
978745	Internal RxNorm lookup
978746	Internal RxNorm lookup
978747	Internal RxNorm lookup
978755	Internal RxNorm lookup
978757	Internal RxNorm lookup
978777	Internal RxNorm lookup
978778	Internal RxNorm lookup
2618839	Internal RxNorm lookup
2618842	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
23527b8b-9b28-4e6d-9751-33b143975ac7	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
603b0afe-8b26-4c18-86ca-a17a3337c817	Product name	1	20190808
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0069-0196-01	Fragmin	0.2 mL in 1 SYRINGE	INJECTION	0.2		27
0069-0196-02	Fragmin	10 in 1 CARTON	INJECTION	10		27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0069-0196-01	ML - Milliliter	0069-0196	1bc12a39-5f82-483d-9a25-292364aa266e	1	2015-07-20
0069-0196-02	ML - Milliliter	0069-0196	ef28d5f6-2bcf-4fa4-8b99-22e1926607b8	1	2015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DALTEPARIN SODIUM	ACTIVE INGREDIENT	12M44VTJ7B	FRAGMIN (DALTEPARIN SODIUM) INJECTION [PFIZER LABORATORIES DIV PFIZER INC]	4
DALTEPARIN	ACTIVE MOIETY	S79O08V79F	FRAGMIN (DALTEPARIN SODIUM) INJECTION [PFIZER LABORATORIES DIV PFIZER INC]	4
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	FRAGMIN (DALTEPARIN SODIUM) INJECTION [PFIZER LABORATORIES DIV PFIZER INC]	4
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	FRAGMIN (DALTEPARIN SODIUM) INJECTION [PFIZER LABORATORIES DIV PFIZER INC]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	FRAGMIN (DALTEPARIN SODIUM) INJECTION [PFIZER LABORATORIES DIV PFIZER INC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0069-0196	FRAGMIN (DALTEPARIN SODIUM) INJECTION [PFIZER LABORATORIES DIV PFIZER INC]	26	Current NDC, Legacy NDC, 2 package rows	20241114_23527b8b-9b28-4e6d-9751-33b143975ac7.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fragmin	DALTEPARIN SODIUM	Pfizer Laboratories Div Pfizer Inc	23527b8b-9b28-4e6d-9751-33b143975ac7	2025-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020287 application number: NDA020287 ndc (product): 0069-0196

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
12M44VTJ7B	DALTEPARIN SODIUM	9041-08-1	DALTEPARIN SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
978755	dalteparin sodium 10,000 UNT in 1 ML Prefilled Syringe	PSN	23527b8b-9b28-4e6d-9751-33b143975ac7	27
2618839	dalteparin sodium 10,000 UNT in 4 ML Injection	PSN	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978740	dalteparin sodium 12,500 UNT in 0.5 ML Prefilled Syringe	PSN	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978744	dalteparin sodium 15,000 UNT in 0.6 ML Prefilled Syringe	PSN	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978746	dalteparin sodium 18,000 UNT in 0.72 ML Prefilled Syringe	PSN	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978777	dalteparin sodium 25,000 UNT/ML Injectable Solution	PSN	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978725	dalteparin sodium 2500 UNT in 0.2 ML Prefilled Syringe	PSN	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978733	dalteparin sodium 5000 UNT in 0.2 ML Prefilled Syringe	PSN	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978736	dalteparin sodium 7500 UNT in 0.3 ML Prefilled Syringe	PSN	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978757	Fragmin 10,000 UNT in 1 ML Prefilled Syringe	PSN	23527b8b-9b28-4e6d-9751-33b143975ac7	27
2618842	Fragmin 10,000 UNT in 4 ML Injection	PSN	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978741	Fragmin 12,500 UNT in 0.5 ML Prefilled Syringe	PSN	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978745	Fragmin 15,000 UNT in 0.6 ML Prefilled Syringe	PSN	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978747	Fragmin 18,000 UNT in 0.72 ML Prefilled Syringe	PSN	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978778	Fragmin 25,000 UNT/ML Injectable Solution	PSN	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978727	Fragmin 2500 UNT in 0.2 ML Prefilled Syringe	PSN	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978735	Fragmin 5000 UNT in 0.2 ML Prefilled Syringe	PSN	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978737	Fragmin 7500 UNT in 0.3 ML Prefilled Syringe	PSN	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978727	0.2 ML dalteparin sodium 12500 UNT/ML Prefilled Syringe [Fragmin]	SBD	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978735	0.2 ML dalteparin sodium 25000 UNT/ML Prefilled Syringe [Fragmin]	SBD	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978737	0.3 ML dalteparin sodium 25000 UNT/ML Prefilled Syringe [Fragmin]	SBD	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978741	0.5 ML dalteparin sodium 25000 UNT/ML Prefilled Syringe [Fragmin]	SBD	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978745	0.6 ML dalteparin sodium 25000 UNT/ML Prefilled Syringe [Fragmin]	SBD	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978747	0.72 ML dalteparin sodium 25000 UNT/ML Prefilled Syringe [Fragmin]	SBD	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978757	1 ML dalteparin sodium 10000 UNT/ML Prefilled Syringe [Fragmin]	SBD	23527b8b-9b28-4e6d-9751-33b143975ac7	27
2618842	4 ML dalteparin sodium 2500 UNT/ML Injection [Fragmin]	SBD	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978778	dalteparin sodium 25000 UNT/ML Injectable Solution [Fragmin]	SBD	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978725	0.2 ML dalteparin sodium 12500 UNT/ML Prefilled Syringe	SCD	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978733	0.2 ML dalteparin sodium 25000 UNT/ML Prefilled Syringe	SCD	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978736	0.3 ML dalteparin sodium 25000 UNT/ML Prefilled Syringe	SCD	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978740	0.5 ML dalteparin sodium 25000 UNT/ML Prefilled Syringe	SCD	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978744	0.6 ML dalteparin sodium 25000 UNT/ML Prefilled Syringe	SCD	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978746	0.72 ML dalteparin sodium 25000 UNT/ML Prefilled Syringe	SCD	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978755	1 ML dalteparin sodium 10000 UNT/ML Prefilled Syringe	SCD	23527b8b-9b28-4e6d-9751-33b143975ac7	27
2618839	4 ML dalteparin sodium 2500 UNT/ML Injection	SCD	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978777	dalteparin sodium 25000 UNT/ML Injectable Solution	SCD	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978727	0.2 ML Fragmin 12,500 UNT/ML Prefilled Syringe	SY	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978735	0.2 ML Fragmin 25000 UNT/ML Prefilled Syringe	SY	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978737	0.3 ML Fragmin 25000 UNT/ML Prefilled Syringe	SY	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978741	0.5 ML Fragmin 25,000 UNT/ML Prefilled Syringe	SY	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978745	0.6 ML Fragmin 25,000 UNT/ML Prefilled Syringe	SY	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978747	0.72 ML Fragmin 25,000 UNT/ML Prefilled Syringe	SY	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978757	1 ML Fragmin 10,000 UNT/ML Prefilled Syringe	SY	23527b8b-9b28-4e6d-9751-33b143975ac7	27
2618842	4 ML Fragmin 2500 UNT/ML Injection	SY	23527b8b-9b28-4e6d-9751-33b143975ac7	27
2618839	dalteparin sodium 10,000 UNT per 4 ML Injection	SY	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978755	dalteparin sodium 10000 UNT/ML 1 ML Prefilled Syringe	SY	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978740	dalteparin sodium 12,500 UNT per 0.5 ML Prefilled Syringe	SY	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978744	dalteparin sodium 15,000 UNT per 0.6 ML Prefilled Syringe	SY	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978746	dalteparin sodium 18,000 UNT per 0.72 ML Prefilled Syringe	SY	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978725	dalteparin sodium 2500 UNT per 0.2 ML Prefilled Syringe	SY	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978733	dalteparin sodium 5000 UNT per 0.2 ML Prefilled Syringe	SY	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978736	dalteparin sodium 7500 UNT per 0.3 ML Prefilled Syringe	SY	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978777	dalteparin sodium 95,000 UNT in 3.8 ML Injectable Solution	SY	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978757	Fragmin 10,000 UNT per 1 ML Prefilled Syringe	SY	23527b8b-9b28-4e6d-9751-33b143975ac7	27
2618842	Fragmin 10,000 UNT per 4 ML Injection	SY	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978741	Fragmin 12,500 UNT per 0.5 ML Prefilled Syringe	SY	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978745	Fragmin 15,000 UNT per 0.6 ML Prefilled Syringe	SY	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978747	Fragmin 18,000 UNT per 0.72 ML Prefilled Syringe	SY	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978727	Fragmin 2500 UNT per 0.2 ML Prefilled Syringe	SY	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978778	Fragmin 25000 UNT/ML Injectable Solution	SY	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978735	Fragmin 5000 UNT per 0.2 ML Prefilled Syringe	SY	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978737	Fragmin 7500 UNT per 0.3 ML Prefilled Syringe	SY	23527b8b-9b28-4e6d-9751-33b143975ac7	27
978778	Fragmin 95,000 UNT in 3.8 ML Injectable Solution	SY	23527b8b-9b28-4e6d-9751-33b143975ac7	27

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0069-0196-01	00069019601	0.2 mL in 1 SYRINGE	0.2 ml					Historical
0069-0196-02	00069019602	10 SYRINGE in 1 CARTON (0069-0196-02) / .2 mL in 1 SYRINGE (0069-0196-01)	10 syringe	2015-04-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fragmin	Pfizer Laboratories Div Pfizer Inc \| Pfizer Manufacturing Belgium NV \| Pfizer Health AB	2025-09-30	HUMAN PRESCRIPTION DRUG LABEL	27