NDC 52959-535

temazepam

Temazepam

temazepam is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by H.j. Harkins Company, Inc.. The primary component is Temazepam.

• Product ID: 52959-535_54f020bf-54a5-4a05-98f2-c7ca8e25be3f
• NDC: 52959-535
• Product Type: Human Prescription Drug
• Proprietary Name: temazepam
• Generic Name: Temazepam
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 1987-04-21
• Marketing Category: ANDA / ANDA
• Application Number: ANDA071456
• Labeler Name: H.J. Harkins Company, Inc.
• Substance Name: TEMAZEPAM
• Active Ingredient Strength: 15 mg/1
• Pharm Classes: Benzodiazepine [EPC],Benzodiazepines [CS]
• DEA Schedule: CIV
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 52959-535-60

60 CAPSULE in 1 BOTTLE (52959-535-60)

• Marketing Start Date: 1987-04-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52959-535-28 [52959053528]

temazepam CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA071456
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1987-04-21
• Inactivation Date: 2019-11-13

NDC 52959-535-10 [52959053510]

temazepam CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA071456
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1987-04-21
• Inactivation Date: 2019-11-13

NDC 52959-535-20 [52959053520]

temazepam CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA071456
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1987-04-21
• Inactivation Date: 2019-11-13

NDC 52959-535-60 [52959053560]

temazepam CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA071456
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1987-04-21
• Inactivation Date: 2019-11-13

NDC 52959-535-12 [52959053512]

temazepam CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA071456
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1987-04-21
• Inactivation Date: 2019-11-13

NDC 52959-535-24 [52959053524]

temazepam CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA071456
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1987-04-21
• Inactivation Date: 2019-11-13

NDC 52959-535-40 [52959053540]

temazepam CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA071456
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1987-04-21
• Inactivation Date: 2019-11-13

NDC 52959-535-30 [52959053530]

temazepam CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA071456
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1987-04-21
• Inactivation Date: 2019-11-13

NDC 52959-535-15 [52959053515]

temazepam CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA071456
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1987-04-21
• Inactivation Date: 2019-11-13

Drug Details

Active Ingredients

Ingredient	Strength
TEMAZEPAM	15 mg/1

OpenFDA Data

• SPL SET ID: 2ed81194-be24-45a0-8dde-fbc6ad3d7abe
• Manufacturer:
  • H.J. Harkins Company, Inc.
• UNII:
  • CHB1QD2QSS
• RxNorm Concept Unique ID - RxCUI:
  • 198242
  • 198241

Pharmacological Class

• Benzodiazepine [EPC]
• Benzodiazepines [CS]

NDC Crossover Matching brand name "temazepam" or generic name "Temazepam"

NDC	Brand Name	Generic Name
0228-2076	Temazepam	Temazepam
0228-2077	Temazepam	Temazepam
0378-3110	Temazepam	temazepam
0378-3120	Temazepam	temazepam
0378-4010	Temazepam	temazepam
0378-5050	Temazepam	temazepam
0406-9959	TEMAZEPAM	temazepam
0406-9960	TEMAZEPAM	temazepam
0406-9961	TEMAZEPAM	temazepam
0406-9962	TEMAZEPAM	temazepam
0440-8474	temazepam	temazepam
0440-8475	temazepam	temazepam
0440-8476	temazepam	temazepam
0440-8477	temazepam	temazepam
0615-7808	Temazepam	Temazepam
0615-7809	Temazepam	Temazepam
67877-148	temazepam	temazepam
67877-146	temazepam	temazepam
67877-149	temazepam	temazepam
67877-147	temazepam	temazepam
68071-4083	Temazepam	Temazepam
68071-4100	Temazepam	Temazepam
68084-549	TEMAZEPAM	TEMAZEPAM
68788-6986	Temazepam	Temazepam
68788-7163	Temazepam	Temazepam
68788-6904	Temazepam	Temazepam
70518-0647	temazepam	temazepam
70518-1944	Temazepam	Temazepam
70518-1754	Temazepam	Temazepam
71335-0315	Temazepam	Temazepam
71335-0527	Temazepam	Temazepam
71610-004	TEMAZEPAM	TEMAZEPAM
71610-089	temazepam	temazepam
71610-086	temazepam	temazepam
71610-101	temazepam	temazepam
0781-2201	Temazepam	Temazepam
0781-2202	Temazepam	Temazepam
0904-6436	Temazepam	Temazepam
21695-282	temazepam	temazepam
21695-283	temazepam	temazepam
33261-102	Temazepam	Temazepam
33261-101	Temazepam	Temazepam
33358-332	Temazepam	Temazepam
35356-664	temazepam	temazepam
35356-663	temazepam	temazepam
35356-821	temazepam	temazepam
40032-121	Temazepam	Temazepam
40032-123	Temazepam	Temazepam
40032-122	Temazepam	Temazepam
40032-120	Temazepam	Temazepam