Citalopram

Product NDC: 13107-006
11-digit product format: 131070006
Labeler code: 13107
Product ID: 13107-006_2627f188-05c8-44ac-845e-80678a0c2fdd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Citalopram
Dosage form: TABLET
Route: ORAL
Labeler: Aurolife Pharma LLC
Application: ANDA077031
Marketing category: ANDA
Marketing start: 2009-01-01
Marketing end: 0000-00-00
Substance: CITALOPRAM HYDROBROMIDE
Active strength: 20 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
475812f9-1b2c-4cb0-9e72-1e52f935ae6f	Product name	1	20221114
0b05d650-9b7b-4b36-a6f4-1a850d5a2e64	Product name	1	20151228
e61ea6cb-0b08-40a9-a984-7b23201c7aa2	Product name	1	20151222

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
13107-006-01	2020-01-31	C162847	48780-1	9d75b9d0-5b30-f424-e053-dadaa90a57ce	9f5a14c2-b460-402e-acb4-04402278e64b
13107-006-05	2020-01-31	C162847	48780-1	9d75b9d0-5b30-f424-e053-dadaa90a57ce	9f5a14c2-b460-402e-acb4-04402278e64b
13107-006-10	2020-01-31	C162847	48780-1	9d75b9d0-5b30-f424-e053-dadaa90a57ce	9f5a14c2-b460-402e-acb4-04402278e64b
13107-006-30	2020-01-31	C162847	48780-1	9d75b9d0-5b30-f424-e053-dadaa90a57ce	9f5a14c2-b460-402e-acb4-04402278e64b
13107-006-32	2020-01-31	C162847	48780-1	9d75b9d0-5b30-f424-e053-dadaa90a57ce	9f5a14c2-b460-402e-acb4-04402278e64b
13107-006-60	2020-01-31	C162847	48780-1	9d75b9d0-5b30-f424-e053-dadaa90a57ce	9f5a14c2-b460-402e-acb4-04402278e64b
13107-006-90	2020-01-31	C162847	48780-1	9d75b9d0-5b30-f424-e053-dadaa90a57ce	9f5a14c2-b460-402e-acb4-04402278e64b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
13107-006-01	Citalopram	100 in 1 BOTTLE	TABLET	100	2
13107-006-05	Citalopram	500 in 1 BOTTLE	TABLET	500	2
13107-006-10	Citalopram	100 in 1 CARTON	TABLET	100	2
13107-006-10	Citalopram	10 in 1 BLISTER PACK	TABLET	10	2
13107-006-30	Citalopram	30 in 1 BOTTLE	TABLET	30	2
13107-006-32	Citalopram	30 in 1 BLISTER PACK	TABLET	30	2
13107-006-60	Citalopram	60 in 1 BOTTLE	TABLET	60	2
13107-006-90	Citalopram	90 in 1 BOTTLE	TABLET	90	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13107-006-01	EA - Each	13107-006	d6f6dbb8-62e5-4931-9c5e-3e4d5337fd23	1	2012-07-24
13107-006-05	EA - Each	13107-006	b8996d49-b426-4cdc-b705-bdbdbbdf5f85	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CITALOPRAM HYDROBROMIDE	ACTIVE INGREDIENT	I1E9D14F36	CITALOPRAM TABLET [AUROLIFE PHARMA LLC]	2
CITALOPRAM	ACTIVE MOIETY	0DHU5B8D6V	CITALOPRAM TABLET [AUROLIFE PHARMA LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CITALOPRAM TABLET [AUROLIFE PHARMA LLC]	2
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	CITALOPRAM TABLET [AUROLIFE PHARMA LLC]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CITALOPRAM TABLET [AUROLIFE PHARMA LLC]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	CITALOPRAM TABLET [AUROLIFE PHARMA LLC]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CITALOPRAM TABLET [AUROLIFE PHARMA LLC]	2
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	CITALOPRAM TABLET [AUROLIFE PHARMA LLC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CITALOPRAM TABLET [AUROLIFE PHARMA LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CITALOPRAM TABLET [AUROLIFE PHARMA LLC]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	CITALOPRAM TABLET [AUROLIFE PHARMA LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CITALOPRAM TABLET [AUROLIFE PHARMA LLC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CITALOPRAM TABLET [AUROLIFE PHARMA LLC]	2
CITALOPRAM HYDROBROMIDE	ACTIVE INGREDIENT	I1E9D14F36	CITALOPRAM (CITALOPRAM) TABLET [H.J. HARKINS COMPANY, INC.]	1
CITALOPRAM HYDROBROMIDE	ACTIVE INGREDIENT	I1E9D14F36	CITALOPRAM TABLET [BLENHEIM PHARMACAL, INC.]	1
CITALOPRAM HYDROBROMIDE	ACTIVE INGREDIENT	I1E9D14F36	CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]	1
CITALOPRAM	ACTIVE MOIETY	0DHU5B8D6V	CITALOPRAM (CITALOPRAM) TABLET [H.J. HARKINS COMPANY, INC.]	1
CITALOPRAM	ACTIVE MOIETY	0DHU5B8D6V	CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]	1
CITALOPRAM	ACTIVE MOIETY	0DHU5B8D6V	CITALOPRAM TABLET [BLENHEIM PHARMACAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CITALOPRAM (CITALOPRAM) TABLET [H.J. HARKINS COMPANY, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CITALOPRAM TABLET [BLENHEIM PHARMACAL, INC.]	1
COPOVIDONE	INACTIVE INGREDIENT	D9C330MD8B	CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]	1
COPOVIDONE	INACTIVE INGREDIENT	D9C330MD8B	CITALOPRAM (CITALOPRAM) TABLET [H.J. HARKINS COMPANY, INC.]	1
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	CITALOPRAM TABLET [BLENHEIM PHARMACAL, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CITALOPRAM TABLET [BLENHEIM PHARMACAL, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CITALOPRAM (CITALOPRAM) TABLET [H.J. HARKINS COMPANY, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	CITALOPRAM TABLET [BLENHEIM PHARMACAL, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	CITALOPRAM (CITALOPRAM) TABLET [H.J. HARKINS COMPANY, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CITALOPRAM TABLET [BLENHEIM PHARMACAL, INC.]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	CITALOPRAM TABLET [BLENHEIM PHARMACAL, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CITALOPRAM (CITALOPRAM) TABLET [H.J. HARKINS COMPANY, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CITALOPRAM TABLET [BLENHEIM PHARMACAL, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CITALOPRAM (CITALOPRAM) TABLET [H.J. HARKINS COMPANY, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CITALOPRAM TABLET [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CITALOPRAM (CITALOPRAM) TABLET [H.J. HARKINS COMPANY, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	CITALOPRAM (CITALOPRAM) TABLET [H.J. HARKINS COMPANY, INC.]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	CITALOPRAM TABLET [BLENHEIM PHARMACAL, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CITALOPRAM (CITALOPRAM) TABLET [H.J. HARKINS COMPANY, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CITALOPRAM TABLET [BLENHEIM PHARMACAL, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CITALOPRAM TABLET [BLENHEIM PHARMACAL, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CITALOPRAM (CITALOPRAM) TABLET [H.J. HARKINS COMPANY, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13107-006	CITALOPRAM TABLET [AUROLIFE PHARMA LLC]	2	Legacy NDC, 8 package rows	20120510_9f5a14c2-b460-402e-acb4-04402278e64b.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
I1E9D14F36	CITALOPRAM HYDROBROMIDE	59729-32-7	CITALOPRAM HYDROBROMIDE
0DHU5B8D6V	CITALOPRAM	59729-33-8	Citalopram

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
283672	citalopram 10 MG Oral Tablet	PSN	9f5a14c2-b460-402e-acb4-04402278e64b	2
200371	citalopram 20 MG Oral Tablet	PSN	9f5a14c2-b460-402e-acb4-04402278e64b	2
309314	citalopram 40 MG Oral Tablet	PSN	9f5a14c2-b460-402e-acb4-04402278e64b	2
283672	citalopram 10 MG Oral Tablet	SCD	9f5a14c2-b460-402e-acb4-04402278e64b	2
200371	citalopram 20 MG Oral Tablet	SCD	9f5a14c2-b460-402e-acb4-04402278e64b	2
309314	citalopram 40 MG Oral Tablet	SCD	9f5a14c2-b460-402e-acb4-04402278e64b	2
283672	citalopram 10 MG (as citalopram HBr 12.49 MG) Oral Tablet	SY	9f5a14c2-b460-402e-acb4-04402278e64b	2
200371	citalopram 20 MG (as citalopram HBr 24.99 MG) Oral Tablet	SY	9f5a14c2-b460-402e-acb4-04402278e64b	2
309314	citalopram 40 MG (as citalopram HBr 49.98 MG) Oral Tablet	SY	9f5a14c2-b460-402e-acb4-04402278e64b	2
283672	citalopram 10 MG Oral Tablet	PSN	793c9089-8139-4d21-9e8c-64eb0d554063	1
200371	citalopram 20 MG Oral Tablet	PSN	d9785b1d-f224-42cc-9f46-402feb3f9b15	1
200371	citalopram 20 MG Oral Tablet	PSN	33694be4-87ce-4d25-92f6-6ae517bdf5ff	1
283672	citalopram 10 MG Oral Tablet	SCD	793c9089-8139-4d21-9e8c-64eb0d554063	1
200371	citalopram 20 MG Oral Tablet	SCD	33694be4-87ce-4d25-92f6-6ae517bdf5ff	1
200371	citalopram 20 MG Oral Tablet	SCD	d9785b1d-f224-42cc-9f46-402feb3f9b15	1
283672	citalopram 10 MG (as citalopram HBr 12.49 MG) Oral Tablet	SY	793c9089-8139-4d21-9e8c-64eb0d554063	1
200371	citalopram 20 MG (as citalopram HBr 24.99 MG) Oral Tablet	SY	d9785b1d-f224-42cc-9f46-402feb3f9b15	1
200371	citalopram 20 MG (as citalopram HBr 24.99 MG) Oral Tablet	SY	33694be4-87ce-4d25-92f6-6ae517bdf5ff	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
13107-006-01	13107000601	100 in 1 BOTTLE	Historical
13107-006-05	13107000605	500 in 1 BOTTLE	Historical
13107-006-10	13107000610	100 in 1 CARTON	Historical
13107-006-30	13107000630	30 in 1 BOTTLE	Historical
13107-006-32	13107000632	30 in 1 BLISTER PACK	Historical
13107-006-60	13107000660	60 in 1 BOTTLE	Historical
13107-006-90	13107000690	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Citalopram Hydrobromide Tablets, USP	Blenheim Pharmacal, Inc.	2015-03-05	HUMAN PRESCRIPTION DRUG LABEL	1
Citalopram - Aurolife Pharma LLC	Aurolife Pharma LLC	2012-04-24	Human Prescription Drug Label	2
Citalopram - H.J. Harkins Company, Inc. \| Aurolife Pharma LLC	H.J. Harkins Company, Inc. \| Aurolife Pharma LLC	2011-11-02	Human Prescription Drug Label	1
Citalopram Tablets, USP	RedPharm Drug Inc. \| Aurobindo Pharma Limited	2011-08-17	Human Prescription Drug Label	1

Citalopram

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#